Drug & medication recalls Moderate risk

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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