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Drug FDA Class II Ongoing Failed specifications

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

AvKARE Published Feb 19, 2025

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

Out of Specification for Dissolution

Hazards

Failed Dissolution · primary

Affected products (1)

Irbesartan Tablets USP, 300 mg, 50 Tablets (5 x 10) Unit Dose per carton, Manufactured for: AvKARE, Pulaski, TN 38478. NDC 50268-442-15

IRBESARTAN · 341 cartons

NDC: 50268-441, 50268-440, 50268-442, 50268-440-11, 50268-440-15, 50268-441-11, 50268-441-15, 50268-442-11, 50268-442-15
Lot codes: 45279
Code info: Lot 45279, Exp 03/31/2025

Affected areas

Nationwide

Timeline

  1. Initiated
    Jan 21, 2025
  2. Published
    Feb 19, 2025
Recall number
D-0224-2025
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.