The Recall Desk
HighFDA (Drugs)·D-0041-2025·Announced 2024-11-13

Generic Ibuprofen 800mg Recalled Due to Failed Impurity and Degradation Specifications

Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide due to failed impurity specifications discovered during 18-month stability testing.

What this means for you

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: This is an FDA Class II recall involving pharmaceutical impurities discovered during stability testing, with no reported illnesses or injuries. The failed quality specifications represent a potential risk to consumers but no actual harm has been documented. Per the severity rubric, pharmaceutical quality failures without reported harm correspond to a High rating.

Plain-English summary

Direct Rx is recalling 1,410 bottles of Ibuprofen 800mg tablets distributed nationwide in the United States. The product, a generic equivalent to Motrin, was manufactured by Dr. Reddy's Laboratories LA, LLC in Shreveport, Louisiana, and packaged and distributed by Direct Rx from Dawsonville, Georgia.

The product failed impurity specifications during 18-month stability testing, which is part of FDA-required quality testing for pharmaceuticals.

Consumers who have purchased this medication should contact their healthcare provider or pharmacist regarding alternative pain relief options. The specific lot numbers and National Drug Code (NDC) numbers of affected products are listed in the official FDA recall notice. The product was distributed nationwide, so anyone in the United States who purchased this medication may be affected.

The recalled product

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 cou
Manufacturer
Direct Rx
Category
Drug — Oral Tablets
Hazard
  • impurities
  • degradation

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • Lot #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

Distribution

Distributed nationwide across the United States.

Related recalls

Same category