Acetaminophen Tablets recall
FDA recall D-0471-2025 · initiated May 22, 2025
Aurobindo Pharma USA Inc recalled Acetaminophen Tablets in May 2025 — an FDA Class II recall (D-0471-2025) because cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 4,608 bottles
Details
- Product
- Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
- Recalling company
- Aurobindo Pharma Limited
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide.
- Initiated
- May 22, 2025
- FDA report date
- Jun 25, 2025
Frequently asked
- Was Acetaminophen Tablets recalled?
- Aurobindo Pharma USA Inc recalled Acetaminophen Tablets in May 2025 — an FDA Class II recall (D-0471-2025) because cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Acetaminophen Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0471-2025 was: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
- Is a recalled Acetaminophen Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acetaminophen Tablets are affected?
- Distributed: USA Nationwide.. The recall covers these lots — Lot#: AEF124004A, Exp date 08/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0471-2025.