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Class II: temporary or reversible health riskOngoing

Aurobindo Pharma Acetaminophen Tablets Recall

Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon

Aurobindo Pharma USA Inc · East Windsor, NJ

Risk level
Class II
Reported by FDA
Jun 25, 2025
Recall ID
D-0471-2025
Check your lot numberHow we source this data

Summary

Aurobindo Pharma recalled Acetaminophen Tablets starting May 22, 2025. The FDA classified it as Class II (temporary or reversible health risk) and published enforcement report D-0471-2025 on Jun 25, 2025. Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets). Status: Ongoing.

Why it was recalled

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

Product description

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

Lot numbers, UPCs & expiration codes

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

Where it was sold

USA Nationwide.

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0471-2025
Classification
Class II
Status
Ongoing
Recall initiated
May 22, 2025
FDA report date
Jun 25, 2025
Quantity
4,608 bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Aurobindo Pharma USA Inc

Original FDA data

Every field from FDA enforcement report D-0471-2025, exactly as published.

Show all FDA fields
City
East Windsor
State
NJ
Status
Ongoing
Country
United States
Event ID
96907
Address
279 Princeton Hightstown Rd
Code information
Lot#: AEF124004A, Exp date 08/31/2026
Postal code
08520-1401
Report date
Jun 25, 2025
Product type
Drugs
Recall number
D-0471-2025
Classification
Class II
Recalling firm
Aurobindo Pharma USA Inc
Product quantity
4,608 bottles
Reason for recall
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Voluntary / mandated
Voluntary: Firm initiated
Product description
Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle, WA 98109, NDC 72288-405-10
Distribution pattern
USA Nationwide.
Recall initiation date
May 22, 2025
Initial firm notification
E-Mail
Center classification date
Jun 17, 2025

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0471-2025, published Jun 25, 2025. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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