Drug and pharmaceutical recalls
17622 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2024-02-07FDA-DrugTeva Pharmaceuticals USA, IncClass IIBudesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 USA, NDC 0591-2510-30
Failed Dissolution Specifications
- 2024-02-07FDA-DrugLupin Pharmaceuticals Inc.Class IICefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-405-01
Failed Impurities/Degradation Specifications
- 2024-01-31FDA-DrugHaleon US Holdings LLCClass IRobitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Microbial Contamination of Non-Sterile Products
- 2024-01-31FDA-DrugHaleon US Holdings LLCClass IRobitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distributed by: GSK Consumer Healthcare, Warren, NJ 07059
Microbial Contamination of Non-Sterile Products
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIFexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India, b) 45 Tablets per bottle, NDC 51316-800-45; Distributed by: CVS Pharmacy, Inc., Woonsocket, RI 02895, Made in India, c) 150 Tablets per bottle, NDC 51660-998-55, Distributed by: Ohm Laboratories Inc., New Brunswick, NJ 08901, Made in India.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIZolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-308-88.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIZolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-307-88.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IINiacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-539-81.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IINiacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited, Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-613-81.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIMesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 63304-175-13.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IILurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-579-83.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IILurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191(U.T. of D & NH), INDIA, NDC 47335-639-83.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIFebuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191, (U.T. of D & NH), INDIA, NDC 47335-722-83.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IIFebuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Ltd., Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), INDIA, NDC 47335-721-83.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugSUN PHARMACEUTICAL INDUSTRIES INCClass IICinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Industries Limited Survey No. 259/15, Dadra-396 191 (U.T. of D & NH), India, NDC 47335-380-83.
CGMP Deviations: Microbial contamination was reported in stagnant water in the duct of the manufacturing equipment.
- 2024-01-31FDA-DrugBE PHARMACEUTICALS AGClass IIFosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial, Rx Only, Distributed by BE Pharmaceuticals Inc. 203 New Edition Court Cary, NC 27511, Made in India, NDC 71839-104-01.
Lack of Sterility Assurance: Aseptic process simulation failure.
- 2024-01-31FDA-DrugPFIZERClass IBleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC 61703-332-18
Presence of particulate matter: glass
- 2024-01-31FDA-DrugStrides Pharma Inc.Class IIMethoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Strides Pharma Inc. East Brunswick, NJ 08816, NDC 64380-752-16
Failed Dissolution Specifications
- 2024-01-31FDA-DrugGlenmark Pharmaceuticals Inc., USAClass IIFluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Village: Kishanpura, Baddi Nalagarh Road, District: Solan, Himachal Pradesh - 173205, India, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, NDC 68462-185-56
Failed Excipient Specifications: OOS for assay of Isopropyl Alcohol
- 2024-01-31FDA-DrugIntegraDose Compounding Services LLCClass IIVasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
Subpotent Drug
- 2024-01-31FDA-DrugAmerisource Health Services LLCClass IIIBenzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC 68084-214-01; Individual Dose NDC 68084-214-11
Superpotent drug: Assay results were slightly above specification at the time zero point.
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IISecret Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-380-10, UPC 0 37000 79884 2
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IISecret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-383-10, UPC: 0 37000 72986 0
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IISecret, Dry Spray, Aluminum chlorohydrate 23.5% Antiperspirant, Waterlily, Topical Spray Can, Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-381-10; UPC 0 37000 72372 1; 12/pack UPC 0 37000 72991 4
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IISecret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000 71109 4, (b) 6OZ (170g), NDC 37000-134-17, UPC 0 37000 71108 7; (c) twin pack-2 Topical spray cans, each can Net Wt. 6OZ (170g), NDC: 37000-134-01, UPC 0 37000 58690 6; Dist. by: Procter & Gamble, Cincinnati, OH 45202,
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IIOld Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-385-10, UPC 0 37000 74947 9
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IIOld Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-387-10, UPC 0 37000 72974 7
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IIOld Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deodorant Spray, Topical spray can, Net WT 6.0 OZ (170g), Distributed by Procter & Gamble, Cincinnati, OH 45202. NDC: 37000-199-60, UPC 0 12044 00191 2
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IIOld Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash 18 Fl Oz (532 mL), 2-in-1 Shampoo & Conditioner 13.5 Fl Oz (400 mL), and Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g). Dist. by: Procter & Gamble, Cincinnati, OH 45202. Gift Set NDC 69423-590-01, UPC 12044 04853 5
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- 2024-01-24FDA-DrugThe Procter & Gamble CompanyClass IISecret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting Powder, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Gamble, Cincinnati, OH 45202. NDC: 69423-478-10, UPC 0 37000 74772 7
CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
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