Drug FDA Class II Ongoing cGMP deviation

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

Aurobindo Pharma USA Inc Published Jun 25, 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 Aurobindo Pharma USA Inc or your place of purchase with questions, and see the source record below for full details.

Reason for recall

cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).

Hazards

Tablet Discoloration · primary

Affected products (1)

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10

AMAZON BASIC CARE ACETAMINOPHEN · 4,608 bottles

NDC: 72288-405, 72288-405-10

Code info: Lot#: AEF124004A, Exp date 08/31/2026

Affected areas

Nationwide

Timeline

Initiated

May 22, 2025
Published

Jun 25, 2025

Recall number: D-0471-2025
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.