Primidone Tablets Recalled Due to Cross-Contamination with Acemetacin
Lannett Company Inc. is recalling Primidone 250mg tablets nationwide due to cross-contamination with trace amounts of Acemetacin in the active pharmaceutical ingredient. The recall affects 44,865 bottles distributed across the USA.
What this means for you
Cosmetic or documentation issue. No expected health impact, but the manufacturer is correcting the affected products.
Our severity reasoning: This is an FDA Class III recall. The source text describes trace amounts of cross-contamination as the hazard, with no reported illnesses, injuries, or deaths, and no indication that adverse health consequences are likely. Class III recalls are by definition unlikely to cause adverse health consequences.
Plain-English summary
Lannett Company Inc. is recalling Primidone (Primidone) Tablets USP, 250mg, 100-count bottles nationwide. The recall has been issued because the active pharmaceutical ingredient (API) in these tablets is contaminated with trace amounts of Acemetacin API as a result of cross-contamination.
The affected product is distributed by Lannett Company, Inc., Philadelphia, PA 19136, with NDC 0527-1231-01. A total of 44,865 bottles are involved in this recall. The affected lot numbers and expiration dates are: Lot 25283038A (Exp 1/31/2028); Lot 25283564A, 25283565A (Exp 3/31/2028); Lot 25285712A (Exp 08/31/2028); Lot 25284105A (Exp 4/30/2028); and Lot 25284874A, 25284875A (Exp 08/31/2028).
Patients taking this medication should not stop taking their medication without speaking with their healthcare provider. Patients should contact their pharmacist or healthcare provider if they have questions or concerns about their medication.
The recalled product
- Product
- PRIMIDONE (PRIMIDONE)
- Brand
- PRIMIDONE
- Manufacturer
- Lannett Company Inc.
- Hazard
- cross-contamination
- acemetacin-trace
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (11)
- 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.
UPCs (1)
- 0305871231011
Distribution
Distributed nationwide across the United States.