Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136,
Summary
The FDA issued a Class III for Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett by Lannett Company Inc.. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API..
Details
Source
Drug Recall
External ID
D-0533-2026
Action Date
2026-05-27
Status
Ongoing
Category
drug
Product Description
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Lot/Code Info: Lot#: 25283038A, Exp 1/31/2028; 25283564A, 25283565A, Exp 3/31/2028; 25285712A Exp 08/31/2028; 25284105A, Exp 4/30/2028; 25284874A, 25284875A, Exp 08/31/2028.
Quantity Affected: 44865 bottles
Reason for Recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Distribution
USA Nationwide
Type: Voluntary: Firm initiated
Recall Initiated: 2026-04-24
Company
Seymour, IN
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 43 drug recalls issued in the same week, part of 267 drug-related FDA actions this month.
Lannett Company Inc. has 9 FDA actions in our database, including 9 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 (Lannett Company Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does Lannett Company Inc. have FDA actions?
Lannett Company Inc. has 9 FDA actions in our database, including 9 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0533-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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