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Drug FDA Class II Ongoing Failed specifications

Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.

Preferred Pharmaceuticals, Inc. Published Sep 4, 2024

Risk level

Class II

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

Severity score 50/100

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 Preferred Pharmaceuticals, Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Failed Impurities/Degradation Specifications - at 18-month Stability testing

Hazards

Failed Impurities/Degradation Specifications · primary

Affected products (1)

Ibuprofen Tablets, USP 400mg, Generic for Motrin, Pkg Size: 30 tablets per bottle, Mfg: Dr. Reddy's Laboratories, Louisiana, Shreveport, NDC 68788-9110-03.

266 bottles

Lot codes: B0223H
Code info: Lot: B0223H, Exp: 5/31/2026; C3023H, Exp: 9/30/2026.

Affected areas

CaliforniaNevada

Timeline

  1. Initiated
    Aug 8, 2024
  2. Published
    Sep 4, 2024
Recall number
D-0647-2024
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.