Drug recalls

1. Class III16 Sep 2026Imprimisrx Nj LLC
   Povidone Iodine 1.25% / Proparacaine HCl 0.5% Ophthalmic Solution, 10 mL per dropper bottle, For Office Use Only, Imprimis NJOF, LLC, 1705 Route 46 West, Unit 6B, Ledgewood, NJ 07852, NDC 71384-732-10
   Subpotent Drug
2. Not Yet Classified16 Sep 2026Ourpharma LLC
   fentaNYL Citrate, 1,000 mcg/100 mL (10mcg/mL) Injection solution in 100 mL, 0.9% NaCl Bag, OurPharma LLC, 2512 S. City Lake, Fayetteville, AR, NDC 73013-1013-01.
   Labeling: Not Elsewhere Classified: Complaint received on 08/31/2026 regarding the discrepancy of the IV bag expiry (07/31/2026 and 11/30/2026) and the product expiry (12/09/2026).
3. Class III16 Sep 2026Ajanta Pharma USA INC
   Fluphenazine Hydrochloride Tablets, USP, 1mg, 100-count bottles, Rx Only, Marketed by: Ajanta Pharma USA Inc., Bridgewater, NJ 08807, Made in India, NDC 27241-255-01.
   Failed impurities/degradation specifications: (OOS) for Organic Impurities by HPLC (Impurity-A) during testing at the 18 months long term stability. Result: 1.1 percent. Spec: 1.0 percent.
4. Class I16 Sep 2026Baxter Healthcare Corporation
   Dextrose Injection, USP, 70 %, 2000 mL bags, Rx Only, Baxter Healthcare Corporation Deerfield, IL, 60016, Made in USA, NDC 00338-0719-06
   Presence of Particulate Matter: particulate matter identified as stainless steel particles in the solution.
5. Class II9 Sep 2026Baxter Healthcare Corporation
   Clindamycin Injection USP in 5% Dextrose, 900 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3814-50.
   CGMP Deviations
6. Class II9 Sep 2026Baxter Healthcare Corporation
   Vasopressin, in 0.9% Sodium Chloride Injection, 20 units per 100 mL (0.2 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60012 USA, NDC 0338-9640-12.
   CGMP Deviations
7. Class II9 Sep 2026Baxter Healthcare Corporation
   Daptomycin, in 0.9% Sodium Chloride Injection, 1,000 mg per 100 mL (10 mg/mL), 1,000 mg total, in 1000 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, N…
   CGMP Deviations
8. Class I9 Sep 2026Optimal Balance Pharmacy
   Glutathione 200 mg/mL, 30 mL sterile multidose vial, Each vial contains: Glutathione, Ascorbic Acid, Benzyl Alcohol & sterile water for injection, For IM or IV Injection Use Only, RX only, Optimal Balance Pharmacy, 2…
   Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
9. Class II9 Sep 2026Baxter Healthcare Corporation
   CARDENE IV (Nicardipine Hydrochloride) in 0.83% Sodium Chloride Injection, 40 mg in 200 mL (0.2 mg/mL) in GALAXY Single-Dose Container, Manufactured and Marketed by: Baxter Healthcare Corporation, Deerfield, IL 60015 …
   CGMP Deviations
10. Class III9 Sep 2026Supernus Pharmaceuticals, Inc.
    Trokendi XR, (topiramate) extended-release capsules, 50 mg, 30 Capsules, Rx only, Manufactured by: Catalent Pharma Solutions, Winchester, KY 40391 USA, Manufactured for: Supernus Pharmaceuticals, Inc., Rockville, MD 2…
    Failed dissolution specifications.
11. Class III9 Sep 2026American Health Packaging
    Buprenorphine Sublingual Tablets (C-III), 2 mg, 30 Tablets (3x10), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217, Carton NDC#: 60687-481-21, (Individual Dose NDC: 60687-481-11).
    Labeling: Label Mix-up
12. Class II9 Sep 2026Teva Pharmaceuticals Usa, INC
    traZODone Hydrochloride Tablets, USP, 50 mg, Rx only, 100 Tablets, Manufactured in Croatia By: Pliva Hrvatska d.o.o, Zagreb, Croatia, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054, NDC 50111-560-01
    Presence of Foreign Tablets/Capsules
13. Class I9 Sep 2026Baxter Healthcare Corporation
    0.9% Sodium Chloride Injection USP 500 mL, VIAFLEX Plastic Containers, with 24 units per case. Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, Made in USA, NDC 0338-0049-03
    Presence of particulate matter: Particulates identified as fiberglass
14. Class II9 Sep 2026Allies Group Inc.
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 3ml - 0.1 fl. oz, Sachet: Single use only, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 0689…
    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
15. Class II9 Sep 2026Allies Group Inc.
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 90ml - 3 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 075853
    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
16. Class II9 Sep 2026Baxter Healthcare Corporation
    Pantoprazole Sodium in 0.9% Sodium Chloride Injection, 80 mg/100 mL (0.8 mg/mL) Single-Dose Infusion Bag in 100 mL GALAXY Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015, USA, NDC 0338…
    CGMP Deviations
17. Class II9 Sep 2026Lexia LLC
    Broadway Joe's Pain Cream, (Histamine Dihydrochloride 0.025%), 1500mg CBD Isolate, 1000mg Hempseed oil, 2 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-5, UPC 8 50041 64003 7
    CGMP Deviations: Potential contamination of raw material
18. Class II9 Sep 2026Baxter Healthcare Corporation
    Daptomycin, in 0.9% Sodium Chloride Injection, 500 mg per 50 mL (10 mg/mL), 500 mg total, in 50 mL Single Dose Container (24 bags/carton), Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60…
    CGMP Deviations
19. Class II9 Sep 2026Baxter Healthcare Corporation
    Nexterone (amiodarone HCI), 360 mg/200 mL (1.8 mg/mL) in GALAXY Single-Dose Container, sterile, Nonpyrogenic, iso-osmotic solution in Dextrose, Baxter Healthcare Corporation, Deerfield, IL 60015, Made in the USA, NDC …
    CGMP Deviations
20. Class II9 Sep 2026Baxter Healthcare Corporation
    Clindamycin Injection USP in 5% Dextrose, 600 mg per 50 mL (12 mg/mL) in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Baxter healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-3612-50.
    CGMP Deviations
21. Class II9 Sep 2026Allies Group Inc.
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 50ML - 1.7 fl. oz Tube, Made in U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 073224
    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
22. Class II9 Sep 2026Baxter Healthcare Corporation
    Dexmedetomidine Hydrochloride in 0.9% Sodium Chloride Injection, 400 mcg per 100 mL (4 mcg/mL) in Galaxy 100 mL Single Dose Container, Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015, USA, NDC 0338-9557-12.
    CGMP Deviations
23. Class II9 Sep 2026Allies Group Inc.
    THE ONE SPF 50 INVISIBLE SUNSCREEN GEL, (Avobenzone 3%, Homosalate 7%, Octocrylene 10%, Octisalate 5%), 20ml - 0.7 fl. oz. Tube, Made in the U.S.A, Distributed by Allies Group Pte Ltd, Singapore 068914. UPC 8 885014 …
    Subpotent Product: Firm Testing indicated the affected product may not reliably provide the SPF 50 protection stated on the label.
24. Class II9 Sep 2026Baxter Healthcare Corporation
    Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 033…
    CGMP Deviations
25. Class II9 Sep 2026Lexia LLC
    Broadway Joe's Pain Cream, 3000 gm CBD, (Histamine Dihydrochloride 0.025%) (CDB Isolate 3000mg, HempSeed Oil 2000mg),4 oz-jar, Produced for Broadway Joe's, Franklin, TN, 37067, NDC 83088-8120-6; UPC 8 50041 64004 4
    CGMP Deviations: Potential contamination of raw material
26. Class II9 Sep 2026Baxter Healthcare Corporation
    MYXREDLIN, Insulin Human in 0.9% Sodium Chloride Injection, 100 units/100 mL (1 unit/mL), Rx only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338-0126-12.
    CGMP Deviations
27. Class III9 Sep 2026Bionpharma Inc.
    Doxylamine Succinate and Pyridoxine HCl Delayed-Release tablets 10 mg/10 mg, 100-count bottle, Rx Only, MADE IN INDIA, Distributed by: Bionpharma Inc., Princeton, NJ 08540 NDC 69452-206-20.
    Presence of Foreign Tablets/Capsules
28. Class II9 Sep 2026Baxter Healthcare Corporation
    Famotidine Injection in Sodium Chloride Injection, 20 mg, 50 mL in GALAXY Single Dose Container, Rx Only, Sterile Nonpyrogenic, Baxter International Inc., Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 03…
    CGMP Deviations
29. Class II9 Sep 2026Baxter Healthcare Corporation
    Vancomycin Injection, USP, in 0.9% Sodium Chloride, 1g per 200 mL (5 mg/mL) in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3583-01.
    CGMP Deviations
30. Class II9 Sep 2026Baxter Healthcare Corporation
    Vasopressin, in 0.9% Sodium Chloride Injection, 40 units per 100 mL (0.4 units/mL), 100mL Single-Dose Container, Rx only, Sterile, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-9647-12.
    CGMP Deviations
31. Class II9 Sep 2026Sage Products, LLC
    2% Chlorhexidine Gluconate* Cloth, Non-sterile, 6 Disposable cloths, Sage Products LLC, 3909 Three Oaks Road, Cary, Illinois 60013. NDC: 53462-705-26
    Cross Contamination with Other Products
32. Class III9 Sep 2026Chiesi Usa, Inc.
    Revcovi (elapegademase-lvlr) Injection, 2.4mg/1.5mL (1.6 mg/mL), Single-Dose Vial, Rx Only, For Intramuscular Use Only, Mfd. by Chiesi USA, Inc., Cary, NC 27518, NDC 10122-502-01
    Failed Stability Specifications: Out of specification stability result for the protein concentration profile.
33. Class II9 Sep 2026Mylan Pharmaceuticals INC
    Prasugrel Tablets, USP, 10mg, Rx only, 30 Tablets in each bottle, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505, Made in India, NDC 0378-5186-93.
    Failed Dissolution Specifications; product failed to meet 18-month stability testing acceptance criteria
34. Class II9 Sep 2026Baxter Healthcare Corporation
    Clindamycin Injection USP in 5% Dextrose, 900 mg/50 mL (18 mg/mL), in GALAXY 50 mL Single Dose Container, Rx only, Sterile Nonpyrogenic, Manufactured by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 430…
    CGMP Deviations
35. Class II9 Sep 2026Baxter Healthcare Corporation
    Vancomycin Injection, USP in 5% Dextrose, 1 g per 200mL (5 mg/mL), in GALAXY Single-Dose Container, Rx only, Sterile Nonpyrogenic, Iso-osmotic, Baxter Healthcare Corporation, Deerfield, IL, 60015 USA, NDC 0338-3552-48.
    CGMP Deviations
36. Class II9 Sep 2026Baxter Healthcare Corporation
    Clindamycin Phosphate in 0.9% Sodium Chloride Injection, 600 mg per 50 mL (12 mg/mL), 50 mL Single-Dose GALAXY Container, Rx only, Sterile Nonpyrogenic, Baxter Healthcare Corporation, Deerfield, IL 60015 USA, NDC 0338…
    CGMP Deviations
37. Class II9 Sep 2026Mylan Pharmaceuticals INC
    Carton label: Mycophenolate Mofetil for injection, USP, 500 mg/vial, Sterile, 4 Single Dose Vials, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505, Made in India, NDC 67457-386-81. Vial Label…
    Failed Dissolution Specifications
38. Class II9 Sep 2026Golden State Medical Supply Inc.
    Prasugrel HCI, Tablets, USP, 10mg, 30-count bottle, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA 93012, USA, NDC: 51407-445-30.
    Failed Dissolution Specifications. Notification from the manufacturer that lot is being recalled due to failed dissolution
39. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 200 mcg (0.2 mg), packaged in a) 90-count bottles (NDC 16729-457-15) and b) 1000-count bottles (NDC 16729-457-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27…
    Subpotent Drug
40. Class II2 Sep 2026Hikma Pharmaceuticals USA Inc.
    Ramipril Capsules USP, 10 mg, packaged in a) 100 Capsules (NDC 76282-673-01) and b) 500 Capsules (NDC 76282-673-05) bottles, Rx only, Manufactured for: Exelan Pharmaceuticals, Inc., Boca Raton, FL 33432, Manufactured …
    Failed Impurities/Degradation Specifications: OOS result obtained for a process impurity, dicyclohexylurea (DCU).
41. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehra…
    Subpotent Drug
42. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 125 mcg (0.125 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Deh…
    Subpotent Drug
43. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehr…
    Subpotent Drug
44. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 137 mcg (0.137 mg), packaged in a) 90-count bottles (NDC 16729-454-15) b) 1000-count bottles (NDC 16729-454-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617…
    Subpotent Drug
45. Class II2 Sep 2026Lupin Pharmaceuticals Inc.
    Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pithampur (MP) 454 775, INDIA, NDC 68180-956-04.
    Failed content uniformity specifications.
46. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 300 mcg (0.3 mg), 90-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehradu…
    Subpotent Drug
47. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 75 mcg (0.075 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehr…
    Subpotent Drug
48. Class II2 Sep 2026Mallinckrodt Hospital Products Inc.
    Acthar Gel (repository corticotropin injection), 5 mL multiple-dose vial, Rx Only, Mfd. for: Mallinckrodt ARD LLC, Bridgewater, NJ 08807, NDC 63004-8710-1 & NDC 63004-8710-2
    Presence of particulate matter: glass and stopper piece
49. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehr…
    Subpotent Drug
50. Class II2 Sep 2026Church & Dwight Co., Inc.
    Zicam, Cold Remedy, Medicated Nasal Swabs, With Cooling Menthol & Eucalyptus, 20 Single-Use Swabs per carton, Zinc-Free Homeopathic, Distributed by Church & Dwight Co. Inc., Ewing, NJ 08628, UPC 732216301205.
    CGMP Deviations; FDA inspection of the contract manufacturer noted out of limit results for microbiological testing
51. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), packaged in a) 90-count bottles (NDC 16729-456-15), and b) 1000-count bottles (NDC 16729-456-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC …
    Subpotent Drug
52. Class I2 Sep 2026Fresenius Kabi Usa, LLC
    Tyenne (tocilizumab-aazg) Injection, 400 mg/20 mL (20 mg/mL), 20 mL vial, Rx Only, Manufactured by Fresenius Kabi USA, LLC, Lake Zurich, Illinois, 60047, NDC 65219-594-20.
    Presence of particulate matter:An internal investigation at the firm found the product to contain glass particles.
53. Class I2 Sep 2026B Braun Medical INC
    Lactated Ringer's Injection USP, 1000 mL EXCEL container, Rx only, L7500, B. Braun Medical, Inc., Bethlehem, PA 18018-3524 USA, NDC 0264-7750-00
    Presence of Particulate matter.
54. Not Yet Classified2 Sep 2026Safecor Health, LLC
    Ibuprofen, 150 mg per 7.5 mL, Delivers: 7.5 mL, Conc: 20 mg/mL, Oral Suspension, 12mL Oral Syringes, Berry Flavor/Alcohol Free, Mfg By: MCNEIL, Pkg by: Safecor, Woburn, MA
    Cross Contamination with Other Products
55. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), packaged in a) 90-count bottles (NDC 16729-451-15) and b) 1000-count bottles, (NDC 16729-451-17), Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27…
    Subpotent Drug
56. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 88 mcg (0.088 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Dehr…
    Subpotent Drug
57. Class II2 Sep 2026Accord Healthcare, Inc.
    Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottles, Rx Only, Manufactured for: Accord Healthcare, Inc., Raleigh, NC 27617, Manufactured by: Intas Pharmaceuticals Limited, Camp Road, Selaqui, Deh…
    Subpotent Drug
58. Class II2 Sep 2026Apotex Corp.
    Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg, 30 count bottle, Rx only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston, Florida 33326, NDC 60505-4379-3
    Failed Dissolution Specifications; product failed to meet 24-month stability testing acceptance criteria
59. Class II26 Aug 2026American Regent, Inc.
    Cyanocobalamin injection USP, 10,000 mcg/10 mL (1,000 mcg/mL), For IM or SC Use Only, packaged in a) 10 mL Multi-Dose Vial (NDC 0517-0032-01) and b) 25x10 mL Multi-Dose Vials (NDC 0517-0032-25), Rx Only, AMERICAN REGE…
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
60. Class II26 Aug 2026Golden State Medical Supply Inc.
    Carbamazepine Tablets, USP, 200mg, packaged in a)1000-count bottles (NDC 51407-215-10), b) 100-count bottles (NDC 51407-215-01), Rx Only, Manufactured by: Taro Pharmaceutical Industries Ltd., Marketed by: GSMS, Incorp…
    CGMP deviations: tablets with black specks.
61. Class II26 Aug 2026American Regent, Inc.
    Multrys (Trace Elements Injection 4, USP), For intravenous infusion, packaged in a) 1 mL Single-Dose Vial (NDC 0517-9302-01), and b) 25x1 mL Single-Dose Vials (NDC 0517-9302-25) Rx Only, AMERICAN REGENT, INC., SHIRLEY…
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
62. Class II26 Aug 2026American Regent, Inc.
    ACETYLCYSTEINE SOLUTION, USP, 20% (200 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7604-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7604-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
63. Class I26 Aug 2026American Regent, Inc.
    Papaverine HCl Injection, USP, 60 mg/2 mL (30 mg/mL), packaged in a) 2mL Single-Dose Vial (NDC 0517-4002-01), and b) 25x2mL Single-Dose Vials (NDC 0517-4002-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    Presence of Particulate Matter: Product contaminated with particulate matter identified as glass and/or paraformaldehyde
64. Class II26 Aug 2026American Regent, Inc.
    ACETYLCYSTEINE SOLUTION, USP, 10% (100 mg/mL), packaged in a) 4 mL Vial NOT FOR INJECTION (NDC 0517-7504-01), and b) 25x4 mL Vials NOT FOR INJECTION (NDC 0517-7504-25), Rx Only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
65. Class II26 Aug 2026Shilpa Medicare Limited
    PEMRYDI RTU (pemetrexed injection), 100 mg/10 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807.…
    Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
66. Class II26 Aug 2026American Regent, Inc.
    Atropine Sulfate injection, USP, 1 mg/mL, For intravenous Use, Sterile, packaged in a) 1 mL Single-Dose Vial (NDC 0517-1001-01), and b) 25x1 mL Single-Dose Vial (NDC 0517-1001-25), Rx only, AMERICAN REGENT INC., SHIRL…
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
67. Class II26 Aug 2026Regeneron Pharmaceuticals INC
    Libtayo (cemiplimab-rwlc) Injection, 350 mg/7 mL (50 mg/mL), For Intravenous Infusion After Dilution, Single-Dose Vial, Rx only, Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591; Marketed by: Rege…
    Lack of Assurance of Sterility
68. Class II26 Aug 2026American Regent, Inc.
    Nitroglycerin injection, USP, 50 mg/10 mL (5 mg/mL), packaged in a) 10 mL vials (NDC 0517-4810-01), b) 25x10mL vials (NDC 0517-4810-25) RX only, AMERICAN REGENT, INC., Shirley, NY 11967.
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
69. Class II26 Aug 2026Mylan Pharmaceuticals INC
    Acamprosate Calcium, Delayed-Release Tablets, 333 mg, 180 tablets bottles, Rx only, Mylan Pharmaceuticals Inc., Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 266505, NDC 0378-6333-80.
    Failed Dissolution Specifications
70. Class II26 Aug 2026Shilpa Medicare Limited
    PEMRYDI RTU(pemetrexed injection), 500 mg/50 mL (10 mg/mL), Single-dose vial, Rx only, Manufactured by: Zydus Lifesciences Limited, Ahmedabad, India; Distributed by: Amneal Pharmaceuticals LC, Bridgewater, NY 08807. …
    Discolored solution. The firm has received market complaints reporting green to dark green discoloration in certain vials
71. Class II26 Aug 2026American Regent, Inc.
    niCARdipine Hydrochloride Injection, USP, 25 mg/10mL (2.5 mg/mL), packaged in a) 10 mL Single Dose Vial (NDC 72572-470-01) and b) 10x10 mL Single Dose Vials (NDC 72572-470-10), Rx Only, Mfd for: Civica, Inc., Lehi, UT…
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
72. Class II26 Aug 2026American Regent, Inc.
    AMINAOCAPROIC ACID INJECTION, USP, 250 mg/mL (5 g/20 mL), packaged in a) 20 mL MULTIPLE DOSE VIAL FOR IV INFUSION (NDC 0517-9120-01), and b) 25x20 mL MULTIPLE DOSE VIALS (NDC 0517-9120-25), Rx Only, American Regent, …
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
73. Class II26 Aug 2026American Regent, Inc.
    Selenious Acid Injection, USP 12 mcg/2 mL (6 mcg/2mL), For intravenous use, packaged in a) 2mL Single-Dose Vial (NDC 0517-6502-01), and b)10x2mL Single-Dose Vial (NDC 0517-6502-10), Rx Only, AMERICAN REGENT, INC., SHI…
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
74. Class I26 Aug 2026Fresenius Kabi Usa, LLC
    Morphine Sulfate Injection, USP, 2 mg /mL, 1 mL single-dose Simplist prefilled syringes, For Intramuscular or Intravenous use, Rx only, Fresenius Kabi, Lake Zurich, IL. Unit of Use NDC Number 76045-004-01; Unit of Sal…
    Labeling: Label Mixup: MicroVault labeled as Morphine 2 mg/1 mL, contains a Prefilled Syringe of Dilaudid 0.5 mg/0.5 mL.
75. Class II26 Aug 2026Sun Pharmaceutical Industries INC
    Carbamazepine Tablets, USP, 200mg, 1000 count bottles, Rx only, Manufactured by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761, Distributed by: Taro Pharmaceuticals USA, Inc., Hawthorne, NY 10532, NDC…
    CGMP Deviations; black spots found on tablets from burnt excipient during manufacturing
76. Class II26 Aug 2026American Regent, Inc.
    Cyanocobalamin injection USP, 1,000 mcg/mL, For IM or SC Use Only, packaged in a) 1 mL Multi-Dose Vial (NDC 0517-0031-01), and b) 25x1 mL Multi-Dose Vials (NDC 0517-0031-25) Rx only, AMERICAN REGENT, INC., SHIRLEY, NY…
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
77. Class II26 Aug 2026American Regent, Inc.
    Tralement (trace elements injection 4*, USP), packaged in a) 1mL Single Dose vials (NDC 0517-9305-01) and b) 5x1mL Single Dose vials (NDC 0517-9305-25), Rx only, AMERICAN REGENT, INC., SHIRLEY, NY 11967.
    Presence of Particulate Matter: Product contaminated with particulate matter identified as hair, glass and/or paraformaldehyde
78. Class I19 Aug 2026Buy-herbal
    Kian Pee Wan Capsules, 30-count bottles
    Marketed Without an Approved NDA/ANDA: Product contains undeclared drug ingredients dexamethasone and cyproheptadine.
79. Class II19 Aug 2026Shoolin Pharma Chem Llp
    SILDENAFIL CITRATE USP, 0.100 KG, 100 gm-bag Net Wt, RX ONLY "FOR Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesana, Gujarat, 3…
    CGMP Deviations:Noted during FDA inspection
80. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 7.5mg (5mg/mL), Glycine 7.5 mg (5mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-721-01
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
81. Class I19 Aug 2026Victory Medical Center Pharmacy
    Glutathione (MDV), 200 mg/mL, 30 mL vial, each mL contains Glutathione 200 mg, Ascorbic Acid 20 mg, Benzyl Alcohol 1.5%, Na Hydroxide (Ph Adjust) in sterile water for injection, VMC.
    Microbial Contamination of Sterile Products - out of specifications results were obtained for bacterial endotoxin.
82. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 12.5MG (2.5MG/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-495-05
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
83. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 2.25MG (0.9 mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-811-02
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
84. Class I19 Aug 2026Liebel-flarsheim Company LLC
    Optiray Imaging Bulk Package-350, Ioversol Injection 74%, 350 mg/mL Organically Bound Iodine, 500 mL Multiple-Dose Vial, Rx only, Sterile Solution, Manufactured by: Liebel-Flarsheim Company LLC, Raleigh, NC 27616, Mad…
    Presence of Particulate Matter: comprising polyethylene and other plastic materials, stainless steel and glass.
85. Class II19 Aug 2026Heritage Pharmaceuticals INC
    CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816, NDC 23155-603-51
    Presence of Foreign Substance: presence of particles and white flakes in the reconstituted bottles.
86. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 2.5mg (1mg/mL), Glycine 12.5 mg (5mg/mL), 2.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-711-02
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
87. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 6.75mg (4.5 mg/mL), 1.5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202 NDC 71170-821-01
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
88. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 0.9mg (0.9 mg/mL), 1 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-810-01
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
89. Class II19 Aug 2026Prestige Brands Holdings
    CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per dropper bottle, Sterile, Dist. by Medtech Products Inc., Tarrytown, NY 10591, a Prestige Consumer Healthcare Company. NDC: 67172-999-01 UPC 6 78112 65920 3
    Lack of assurance of sterility. The recall is due to potential contamination
90. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 20mg (5mg/mL), Glycine 20 mg (5mg/mL), 4 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-724-04.
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
91. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 10mg (5mg/mL), Glycine 10 mg (5mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-722-02
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
92. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 9mg (4.5 mg/mL), 2 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-822-02
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
93. Class II19 Aug 2026Shoolin Pharma Chem Llp
    TADALAFIL USP, 0.100 KG, 0.1KG(100gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, …
    CGMP Deviations:Noted during FDA inspection
94. Class II19 Aug 2026Shoolin Pharma Chem Llp
    TADALAFIL USP, 0.500 KG, 0.500KG(500gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715…
    CGMP Deviations:Noted during FDA inspection
95. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 4.5mg (0.9 mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202. NDC 71170-812-03
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
96. Class II19 Aug 2026Novartis Pharmaceuticals Corporation
    Diovan (valsartan) 160 mg, 90 tablets, Rx only, Manufactured by: Patheon Manufacturing Services LLC, Greenville, NC 27834, Distributed by: Novartis Pharmaceutical Corp, East Hanover, NJ 07936, NDC 0078-0359-34
    Failed Dissolution Specifications
97. Class II19 Aug 2026Apollo Care, LLC
    SEMAGLUTIDE 5mg (1mg/mL), Glycine 25 mg (5mg/mL), 5 mL Sterile Multi-Dose Vial, Rx Only, For Subcutaneous Injection Only, APOLLO care, 3801 Mojave Ct, Ste 102, Columbia, MO 65202.NDC 71170-712-03
    Presence of Particulate Matter; identified as a nylon/polyamide and silk/proteinaceous-type material
98. Class I19 Aug 2026Baxter Healthcare Corporation
    Cefazolin in Dextrose, Injection, USP, 2g / 100mL (20mg / mL) Single-Dose Infusion Bag in 100mL GALAXY Plastic Container, Frozen Premix, Sterile, Rx only, Manufactured by Baxter Healthcare Corporation, Deerfield, IL 6…
    Presence of Particulate Matter
99. Class II19 Aug 2026Shoolin Pharma Chem Llp
    SILDENAFIL CITRATE USP, 1.00KG, 1.00KG-bag Net Wt. Rx only " For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, …
    CGMP Deviations:Noted during FDA inspection
100. Class II19 Aug 2026Shoolin Pharma Chem Llp
     TADALAFIL USP, 1.00 KG, 1KG(1000gm)-bag, Rx only, "For Prescription Compounding Only", Shoolin Pharma Chem LLP, Block/Survey no 408, B/H Ratnamani Tubes, Near Maruti Inox, Indrad, Kadi, Mahesania, Gujarat, 382715, In…
     CGMP Deviations:Noted during FDA inspection

Source: openFDA drug enforcement reports. Recalls are reported weekly.