Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT
Recalled November 13, 2024 · FDA recall D-0041-2025 · Direct Rx
Hazard
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing. · FDA Class II
Units
1410 bottles
Sold at
Nationwide in the US
Description
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Product
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).
Manufacturer(s)
Direct Rx
Source: U.S. Food and Drug Administration. Official recall notice on fda.gov →