Class II โ€” Potential Health Hazard

Potential health hazard โ€” use of or exposure to this product may cause temporary or medically reversible adverse health consequences.

Acetaminophen Tablets Recalled by Aurobindo Pharma USA Inc Due to cGMP deviations: Due to confirmed consumer complaints received...

Date: May 22, 2025
Company: Aurobindo Pharma USA Inc
Status: Ongoing
Source: FDA (Drug)

What You Should Do

Stop using this product immediately. Do not consume, use, or distribute it.

Return the product to the place of purchase for a full refund. If you have questions, contact Aurobindo Pharma USA Inc directly.

Affected Products

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

Quantity: 4,608 bottles

Why Was This Recalled?

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

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Aurobindo Pharma USA Inc

Aurobindo Pharma USA Inc has 11 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report