Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Ibuprofen 800mg Recalled by Direct Rx Due to Failed Impurities/Degradation Specifications: Product failed impurity specifications at...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Direct Rx directly.
Affected Products
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).
Quantity: 1410 bottles
Why Was This Recalled?
Failed Impurities/Degradation Specifications: Product failed impurity specifications at the 18-month stability testing.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Direct Rx
Direct Rx has 36 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report