Acetaminophen Tablets recalled over manufacturing violations
- Recall date
- May 22, 2025
- Source
- U.S. Food & Drug Administration (FDA) — enforcement report
- Official notice title
- Aurobindo Pharma USA Inc recalls Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle…
- Recall number
- D-0471-2025
- FDA classification
- Class II
- Brand / firm
- Aurobindo Pharma USA Inc
- Sold / distributed
- USA Nationwide.
Why it was recalled
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Class II means using this product may cause temporary or medically reversible health problems; the chance of serious harm is remote.
What was recalled
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
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