Primidone Tablets recall
FDA recall D-0537-2026 · initiated May 1, 2026
Amerisource Health Services LLC recalled Primidone Tablets in May 2026 — an FDA Class III recall (D-0537-2026) because Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
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: 225,000 tablets
Details
- Product
- Primidone Tablets, USP, 50 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-202-01; Individual Dose NDC: 68084-202-11
- Recalling company
- Amerisource Health Services LLC
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- May 1, 2026
- FDA report date
- May 27, 2026
Frequently asked
- Was Primidone Tablets recalled?
- Amerisource Health Services LLC recalled Primidone Tablets in May 2026 — an FDA Class III recall (D-0537-2026) because Cross contamination with other products: API contaminated with trace amounts of Acemetacin API. 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-0537-2026 was: Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- 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: USA Nationwide. The recall covers these lots — Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027. 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-0537-2026.