CLASS III ONGOING Drug recall · Reported 27 May 2026 · FDA Enforcement Report

Primidone Tablets USP, 250mg recalled by Lannett Company

Lannett is recalling Primidone Tablets USP, 250mg, distributed nationwide in the US. The recall was initiated on 24 Apr 2026 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot#: 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.

NDC0527-1231, 0527-1301

UPC0305871231011

Quantity recalled44865 bottles

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

Recall details

Recall number: D-0533-2026
FDA event ID: 98791
Recalling firm: Lannett, Seymour, IN
Brand: Primidone
Manufacturer: Lannett Company, Inc.
Classification: Class III
Status: Ongoing
Recall initiated: 24 Apr 2026
FDA classified: 18 May 2026
Reported: 27 May 2026
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons

Timeline

24 Apr 2026	Recall initiated by company
18 May 2026	Classified by FDA	+24 days
27 May 2026	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Product as listed by the FDA

Primidone Tablets USP, 250mg, 100-count bottle, Rx only, Distributed by: Lannett Company, Inc., Philadelphia, PA 19136, NDC 0527-1231-01.

Where it was distributed

USA Nationwide

Nationwide

Questions about this recall

Why was it recalled?

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Which lots are 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.

Where was it sold?

USA Nationwide

What should I do if I have it?

Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.

What does Class III mean?

Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

More recalls from Lannett

All 15

Reported	Class	Recall	Company	Reason	Where
8 Jul 2026Drug	CLASS II	Dextroamphetamine Saccharate recalled by Lannett CompanyDextroamphetamine Saccharate, Amphetamine Aspartate Monohydrate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Lannett	Packaging Defects	Nationwide
10 Jun 2026Drug	CLASS II	Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin	Lannett	Potency & Assay	Nationwide
29 Oct 2025Drug	CLASS II	Niacin Extended-release Tablets, USP, 1,000 mg recalledNiacin	Lannett	Potency & Assay	Nationwide
17 Sep 2025Drug	CLASS II	Dextroamphetamine Saccharate, Amphetamine Aspartate recalledDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate And Amphetamine Sulfate	Lannett	Other	OH
3 Sep 2025Drug	CLASS II	Lisdexamfetamine Dimesylate Capsules, 40 mg recalled by Lannett	Lannett	Packaging Defects	Nationwide

Other Primidone recalls

All 6

Reported	Class	Recall	Company	Reason	Where
17 Jun 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg recalled by Amneal PharmaceuticalsPrimidone	Amneal Pharmaceuticals	Other	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 250 mg recalled by Golden State Medical SupplyPrimidone	Golden State Medical Supply	Other	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg recalled by Golden State Medical SupplyPrimidone	Golden State Medical Supply	Other	Nationwide
27 May 2026Drug	CLASS III	Primidone Tablets, USP, 50 mg ( unit dose blister) recalledPrimidone	Amerisource Health Services	Packaging Defects	Nationwide