FDA Drug · D-0041-2025

Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT Rx, Dawsonville, GA 30534, Mfg By: Dr. Reddy's Laboratories LA, LLC, Shreveport, LA 71106, a) NDC 61919-0621-15 (15 count bottles), b) NDC 61919-0621-30 (30 count bottles, c) NDC 61919-0621-40 (40 count bottles), d) NDC 61919-0621-60 (60 count bottles), e) NDC 61919-0621-90 (90 count bottles), f) NDC: 61919-0621-100 and NDC: 61919-0621-71 (100 count bottles), g) NDC 61919-0621-72 (120 count bottles).

Class II · Ongoing

Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.

Affected lots / codes — check yours against thisLot #s: a) 02FE2414, Exp 11/30/26. b) 18JU2407, Exp 11/30/26; 27JY2316, Exp 02/28/27; 13SE2317, 13OC2312, 23AU2307, Exp 03/31/27. c) 25SE2308, Exp 03/31/27. d) 29MA2313, 23MA2315, Exp 12/31/26; 25MY2304, Exp 01/31/27; 26JU2313, 27JY2314, Exp 02/28/27. e) 27SE2322, 30OC2304, 12OC2301, Exp 03/31/27. f) 11SE2322, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.

Recalling firm: Direct Rx, Dawsonville, GA
Classification: Class II (temporary or reversible harm possible)
Status: Ongoing
Quantity: 1410 bottles
Distribution: Nationwide in the US
Recall initiated: August 9, 2024
Classified: November 7, 2024
Initiation: Voluntary: Firm initiated

Official source. This record is published by the U.S. FDA through the openFDA enforcement database. View the unmodified government record:
https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0041-2025%22

Important. Recalls target specific lots and codes — compare the affected lots above against your own product. This page reproduces public FDA data for readability; EveryRecall is independent and not affiliated with the FDA.

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