Primidone Tablets USP recall (Lannett Company Inc.)
DrugClass IIIOngoing
Summary: Lannett Company Inc. is recalling Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.. Reason: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What is being recalled
Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.
Why
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
How serious is it
Class III is the least serious level: using or being exposed to this product is not likely to cause health problems, but it breaks FDA rules.
Where it was sold
USA Nationwide
How to tell if yours is affected
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.
What to do
Check the product name, lot number and expiration date on your package against the codes above. If they match, do not stop taking a prescription medicine without talking to your doctor or pharmacist first; ask them about a replacement. Return or dispose of the product as your pharmacy advises.
Recall facts
| Recall number | D-0533-2026 |
| Category | Drug |
| Agency | U.S. Food and Drug Administration (FDA) |
| Severity | Class III |
| Status | Ongoing |
| Recall started | April 24, 2026 |
| Reported | May 27, 2026 |
| Company | Lannett Company Inc. |
| Company location | Seymour, IN, United States |
| Initiated by | Voluntary: Firm initiated |
| Quantity | 44865 bottles |
More recalls from Lannett Company Inc. · all drug recalls · recalls from April 2026