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Drug FDA Class II Ongoing Failed specifications

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 6

Direct Rx Published Nov 13, 2024

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Direct Rx or your place of purchase with questions, and see the source record below for full details.
Reason for recall

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

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

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).

1410 bottles

Code info: 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, 02FE2419, 23JA2405, 10JA2426, 17MY2416, 05DE2312, 24OC2321, 05FE2433, 20MA2418, 29NO2317, Exp 11/30/26. g) 31MA2308, Exp 12/31/26; 25SE2305, Exp 03/31/27.

Affected areas

Nationwide

Timeline

  1. Initiated
    Aug 9, 2024
  2. Published
    Nov 13, 2024
Recall number
D-0041-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.