Class III · Lower riskActive recall
Primidone
Unlikely to cause harm — often a labeling or packaging issue.
Does this affect you?
Check your lot numberLot#: 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.
Where it was soldUSA Nationwide
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.
What happened
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
What to do
- Check the lot number and expiry on your medicine against the recall above.
- Talk to your pharmacist or doctor before changing anything — don't stop on your own.
- Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).
Who makes it
Made byLannett Company, Inc.
| Brand name | PRIMIDONE |
| Generic name | PRIMIDONE |
| Active ingredient(s) | PRIMIDONE |
| Distributed by / for | Lannett Company, Inc., Philadelphia, PA 19136 |
| NDC | 0527-1231-01 |
Show the full FDA record
| Full product label | Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01. |
| Recalling firm | Lannett Company Inc. |
| Distribution | USA Nationwide |
| Quantity | 44865 bottles |
| Recall initiated | 2026-04-24 |
| Report date | 2026-05-27 |
| Recall completed | — |
| Recall number | D-0533-2026 |
| Classification | Class III |
| FDA status | Ongoing |
| Origin on file | Seymour IN United States |
Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗
This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.