FDA Enforcement Records
Explore FDA enforcement records
Browse published US FDA drug-enforcement recall records. Filter by country, classification, status, or date.
Showing 1701–1725 of 4,679 active FDA enforcement records · Country: united states
- View firm →Class IITerminatedCefixime 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 · Feb 7, 2024 · United States
- View firm →Class IOngoingRobitussin 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 · Jan 31, 2024 · United States
- View firm →Class IOngoingRobitussin 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 · Jan 31, 2024 · United States
- View firm →Class IICompletedFexofenadine 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedZolpidem 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedZolpidem 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedNiacin 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedNiacin 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedMesalamine 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedLurasidone 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedLurasidone 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedFebuxostat 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedFebuxostat 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. · Jan 31, 2024 · United States
- View firm →Class IICompletedCinacalcet 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. · Jan 31, 2024 · United States
- View firm →Class IOngoingBleomycin 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 · Jan 31, 2024 · United States
- View firm →Class IITerminatedMethoxsalen 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 · Jan 31, 2024 · United States
- View firm →Class IITerminatedFluocinolone 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 · Jan 31, 2024 · United States
- View firm →Class IIOngoingVasopressin 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 · Jan 31, 2024 · United States
- View firm →Class IIIOngoingBenzonatate 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 · Jan 31, 2024 · United States
- View firm →Class IITerminatedSecret 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 · Jan 24, 2024 · United States
- View firm →Class IITerminatedSecret, 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 · Jan 24, 2024 · United States
- View firm →Class IITerminatedSecret, 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 · Jan 24, 2024 · United States
- View firm →Class IITerminatedSecret, 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, · Jan 24, 2024 · United States
- View firm →Class IITerminatedOld 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 · Jan 24, 2024 · United States
- View firm →Class IITerminatedOld 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 · Jan 24, 2024 · United States
Only the latest five years of published US FDA drug-enforcement recall records are indexed. The displayed entity is an FDA-recorded recalling firm; country, city, and state are source attributes, not proof of manufacturer, parent company, ownership, legal entity, safety, compliance, or approval.