Drug FDA Class III Ongoing Chemical
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Lannett Company Inc. Published May 27, 2026
Risk level
Class IIIUnlikely to cause harm, but violates labeling or manufacturing rules.
Severity score 48/100
What should you do?
- Check whether you have this product, using the lot codes, UPCs, and dates listed below.
- Do not eat, serve, or sell the affected product.
- Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
- Contact Lannett Company Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Hazards
Acemetacin · primary
Affected products (1)
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
PRIMIDONE · 44865 bottles
NDC: 0527-1231, 0527-1301, 0527-1301-01, 0527-1301-05, 0527-1301-10, 0527-1231-01, 0527-1231-05, 0527-1231-10
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.
Affected areas
Nationwide
Timeline
- InitiatedApr 24, 2026
- PublishedMay 27, 2026
- Recall number
- D-0533-2026
- Agency
- U.S. Food and Drug Administration
- Country
- US
FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.