Direct Rx recalls Ibuprofen 800mg, Generic for: Motrin, Each tablet contains: Ibuprofen, USP 800 mg, Packaged and Distributed by: DIRECT…

Recall date

August 9, 2024

Source

U.S. Food & Drug Administration (FDA) — enforcement report

Recall number

D-0041-2025

FDA classification

Class II

Brand / firm

Direct Rx

Sold / distributed

Nationwide in the US

Why it was recalled

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

Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.

What was recalled

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).