Primidone Tablets recall
FDA recall D-0585-2026 · initiated Jun 3, 2026
Amneal Pharmaceuticals, LLC recalled Primidone Tablets in Jun 2026 — an FDA Class III recall (D-0585-2026) because Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 27,936 100-count bottles
Details
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Oral Solid Dosage Unit, Ahmedabad 382213, INDIA. Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 53746-544-01
- Recalling company
- Amneal
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide within the USA.
- Initiated
- Jun 3, 2026
- FDA report date
- Jun 17, 2026
This recall is linked to a product we cover: Primidone →
Frequently asked
- Was Primidone Tablets recalled?
- Amneal Pharmaceuticals, LLC recalled Primidone Tablets in Jun 2026 — an FDA Class III recall (D-0585-2026) because Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Primidone Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0585-2026 was: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
- Is a recalled Primidone Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Primidone Tablets are affected?
- Distributed: Nationwide within the USA.. The recall covers these lots — Lot AM251676, EXP 11/31/2028. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0585-2026.