FDA Drug Recalls

Recalls / Generics / Ibuprofen

Ibuprofen

26 FDA drug recalls involving generic “Ibuprofen.

DateClassProductFirm
2026-03-02Class IIChildren's Ibuprofen Oral Suspension, USP, 100 mg per 5mL, 4 FL OZ (120 mL) bottle, Manufactured for: Taro PhaSTRIDES PHARMA INC
2024-10-29Class IIIIBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., PrinceDr. Reddy's Laboratories, Inc.
2024-08-06Class IIIBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Dr. Reddy's Laboratories, Inc.
2024-08-06Class IIIBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Dr. Reddy's Laboratories, Inc.
2024-08-06Class IIIBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Dr. Reddy's Laboratories, Inc.
2022-04-13Class IIIbuprofen Tablets USP, 400 mg, 100-count unit dose box, Rx only, MFG: Major Pharma, NDC 0904-5853-61Mckesson Medical-Surgical Inc. Corporate Office
2020-10-22Class IIIFluent Children's Fever + Pain IBUPROFEN Oral Suspension USP 100 mg per 5 mL Pain Reliever/Fever Reducer, 4 flAurobindo Pharma USA Inc.
2020-03-16Class IIIbuprofen 200 mg liquid filled capsules Advil Liqui-Gel Minis, 160 count bottle NDC 0573-1769-89 NDC 0573-1Glaxosmithkline Consumer Healthcare Holdings
2020-03-16Class IIIbuprofen 50 mg per 1.25 mL Oral Suspension Advil Infant Concentrated Drops White Grape 0.75 oz. and 1 oz. bGlaxosmithkline Consumer Healthcare Holdings
2019-09-27Class IIChildren's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 4 fl. oz. (12Taro Pharmaceuticals U.S.A., Inc.
2019-09-27Class IIIbuprofen Oral Suspension USP, 100 mg/5 mL, 4 fl. oz., (118 mL), Rx only, Manufactured by: Taro PharmaceuticalTaro Pharmaceuticals U.S.A., Inc.
2019-09-27Class IIChildren's Ibuprofen Oral Suspension USP, 100 mg per 5 mL, Berry Flavor, Dye-Free, Alcohol Free, 8 fl. oz.(24Taro Pharmaceuticals U.S.A., Inc.
2019-09-27Class IIIbuprofen Oral Suspension USP, 100 mg/5 mL, One Pint, (473 mL), Rx only, Manufactured by: Taro PharmaceuticalsTaro Pharmaceuticals U.S.A., Inc.
2018-08-23Class IIChildren s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, MadisoPfizer Global Supply
2018-01-11Class IIIbuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplTime-Cap Laboratories, Inc.
2018-01-11Class IIIbuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 Time-Cap Laboratories, Inc.
2018-01-11Class IIIbuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, RTime-Cap Laboratories, Inc.
2018-01-11Class IIIbuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, RTime-Cap Laboratories, Inc.
2018-01-11Class IIIbuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablTime-Cap Laboratories, Inc.
2018-01-11Class IIIbuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), RTime-Cap Laboratories, Inc.
2018-01-11Class IIIbuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tTime-Cap Laboratories, Inc.
2018-01-10Class IIIbuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma,Spirit Pharmaceuticals, LLC
2018-01-09Class IIIbuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packagMarksans Pharma Inc.
2018-01-09Class IIIbuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipperMarksans Pharma Inc.
2017-06-16Class IIIbuprofen Tablets, USP 600 mg, 500-count bottle (Capsule Shaped), Rx only, Manufactured for: Time Cap Labs, InTime-Cap Laboratories, Inc.
2013-08-29Class IIIBU (TM) IBUPROFEN Tablets, USP, 800 mg, 500 -count bottle,(NDC 55111-684-05) Rx only, Distributed by Dr. ReddDr. Reddy's Laboratories, Inc.