Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Services LLC, 410 Terry Avenue N., Seattle,
Summary
The FDA issued a Class II for Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com Ser by Aurobindo Pharma USA Inc. Reason: cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets)..
Details
Source
Drug Recall
External ID
D-0471-2025
Action Date
2025-06-25
Status
Ongoing
Category
drug
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/Code Info: Lot#: AEF124004A, Exp date 08/31/2026
Quantity Affected: 4,608 bottles
Reason for Recall
cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet discoloration (brown surface on tablets).
Distribution
USA Nationwide.
Type: Voluntary: Firm initiated
Recall Initiated: 2025-05-22
Company
East Windsor, NJ
Context & Analysis
This is a Class II recall. Class II recalls indicate that use of or exposure to the product may cause temporary or medically reversible health consequences, or that the probability of serious consequences is remote.
This was one of 76 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Aurobindo Pharma USA Inc has 19 FDA actions in our database, including 19 recalls.
Frequently Asked Questions
What is a Class II recall?
A Class II recall means the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse consequences is remote. Consumers should discontinue use.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (Aurobindo Pharma USA Inc) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Aurobindo Pharma USA Inc have FDA actions?
Aurobindo Pharma USA Inc has 19 FDA actions in our database, including 19 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0471-2025" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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