FDAAugust 9, 2024drug

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...

Official recall recorded by the U.S. Food & Drug Administration.

The hazard

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

What to do

FDA enforcement status: Ongoing

Brands named

direct rxdirect

UPCs

61919062115619190621306191906214061919062160619190621906191906211006191906217161919062172

Recall history

Other federal recalls tied to the same brand — a factual pattern, straight from the source data.

FDADULOXETINE D/R, a) 30 mg (NDC 61919-482-30), 30 Caps; b) 30 mg (NDC 61919-482-60), 60 Caps; CYMBALTA, Packaged and Distributed by Direct Rx.2026-06-22
CPSCPressure Washers Recalled Due to Serious Risk of Injury or Death from Shock and Electrocution Hazards; Imported by Patoolio Direct2026-04-16
CPSCFortemotus Direct Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails2026-02-12
CPSCAgrish Adult Portable Bed Rails Recalled Due to Risk of Serious Injury or Death from Entrapment and Asphyxiation; Violate Mandatory Standard for Adult Portable Bed Rails; Sold on Amazon by Agrish Direct2026-01-08
FDAwaterfront BISTRO brand Frozen Raw Shrimp EZ PEEL SHELL & TAIL ON Colossal 8-12 Count per Lb. Net wt. 32oz (2LB). Product is packaged in white flexible plastic pouch with multicolored labeling. UPC is 0 21130 13224 9. Product of Indonesia. DISTRIBUTED BY LUCERNE FOODS, INC. P.O. BOX 99 PLEASANTON...2025-12-18
FDAMARKET 32 by Price Chopper brand, frozen RAW SHRIMP easy peel shell on 26/30 count per pound. Net 16oz. Product is packaged in a clear flexible plastic package with brown label and blue and green printing. UPC is 0 41735 01358 3. Product of Indonesia. PROUDLY DISTRIBUTED BY PRICE CHOPPER, INC. SC...2025-12-18
CPSCDirect Scaffold Supply Recalls Casters for Baker Scaffolding Due to Fall Hazard2025-06-05
FDAThe Drill Stop Kit is the version of the Mini Sterilizable Tray that is used to store, sterilize, verify Drill Stop length, and facilitate the mounting/removal of the Drill Stops. The Drill Stop Kit includes the Release Bracket, which is used for mounting and removing Drill Stops, as well as veri...2025-05-01

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