Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral
Summary
The FDA issued a Class III for Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: by Amneal Pharmaceuticals, LLC. Reason: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer..
Details
Source
Drug Recall
External ID
D-0585-2026
Action Date
2026-06-17
Status
Ongoing
Category
drug
Product Description
Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
Lot/Code Info: Lot AM251676, EXP 11/31/2028
Quantity Affected: 27,936 100-count bottles
Reason for Recall
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Distribution
Nationwide within the USA.
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-03
Company
Bridgewater, NJ
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 66 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Amneal Pharmaceuticals, LLC has 11 FDA actions in our database, including 11 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
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 (Amneal Pharmaceuticals, LLC) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Amneal Pharmaceuticals, LLC have FDA actions?
Amneal Pharmaceuticals, LLC has 11 FDA actions in our database, including 11 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0585-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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