FDA recall, , Low risk
Lannett Primidone Tablets
Primidone Tablets are contaminated with trace amounts of Acemetacin.
Summary by Recall Canary from the FDA notice
What happened
Lannett Company Inc., of Seymour, Indiana, recalled Primidone Tablets USP, 250mg, in 100-count bottles, because the API was contaminated with trace amounts of Acemetacin API. The recall began April 24, 2026, and was added to the FDA's Enforcement Report on May 18, 2026. The product was distributed nationwide in the USA.
The recalled bottles are distributed by Lannett Company, Inc., Philadelphia, PA 19136. The recall involves 44,865 bottles. The FDA classified the recall on May 18, 2026, and it was in the FDA's weekly enforcement report on May 27, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is your bottle affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Primidone Tablets USP, 250mg, 100-count bottle
- NDC
- 0527-1231-01
- Lot code
- 25283038A
- 25283564A
- 25283565A
- 25285712A
- 25284105A
- 25284874A
- 25284875A
Recall details
- Company began the recall
- Sold in
USA Nationwide
- Company
- Lannett Company Inc.Seymour, Indiana
- Hazard
- Contamination
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 98791
- Recall number
- D-0533-2026
- Quantity recalled
- 44865 bottles
All recalls from Lannett Company Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
