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Primidone 250mg Tablets
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DRUG RECALLLOW

Primidone 250mg Tablets

Lannett Company is recalling Primidone 250mg Tablets (NDC 0527-1231-01) due to potential cross-contamination with Acemetacin API.

What to do

Check your medication bottle for NDC 0527-1231-01. If you have this product, contact your pharmacist or healthcare provider to discuss alternative treatment options and return the medication to the point of purchase.

Recalled
Listed
Updated
Recall No.
D-0533-2026
Agency
FDA
Firm
Lannett Company Inc.
Recall ID
98791
Status
ONGOING

Recall at a glance

Quantity recalled
44865 bottles

Why it was recalled

Lannett Company is recalling Primidone Tablets USP, 250mg, in 100-count bottles, NDC 0527-1231-01. The product is being recalled due to cross-contamination with trace amounts of Acemetacin API.

Is mine affected?

Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.

Primidone Tablets USP

Lot code
25283038A, 2028
Strength
250 mg
NDC / UPC
NDC 0527-1231-01

Where it was sold

Distributed nationwide.

Timeline

  1. Firm initiated recall
  2. Publicly announced
  3. Listed on Recall Canary
  4. Summary updated

Other recent recalls from Lannett Company Inc.

All recalls from Lannett Company Inc.

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Editorial summary by Recall Canary · summary updated 2026-05-19 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification