Primidone tablets recalled over potential acemetacin cross-contamination at API manufacturer
Primidone Tablets, USP, 50 mg, from Amneal are being recalled over the potential for cross-contamination with acemetacin API due to an issue at the API manufacturer. 27,936 bottles affected.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA graded this Class III, which the rubric places in the 1-2 band, and the source describes a potential cross-contamination rather than a confirmed one.
Plain-English summary
Primidone Tablets, USP, 50 mg, 100 tablets per bottle, prescription only, manufactured by Amneal Pharmaceuticals Pvt. Ltd. of Ahmedabad, India and distributed by Amneal Pharmaceuticals LLC of Bridgewater, New Jersey, are being recalled. The action covers 27,936 bottles of 100 tablets.
The stated reason is cross-contamination with other products, due to a potential for cross-contamination with acemetacin API arising from an issue at the API manufacturer. The FDA classified the action as Class III, its least serious classification, which is applied where use of the product is not likely to cause adverse health consequences.
The affected lot is AM251676. Distribution was nationwide within the USA.
Patients should not stop taking a prescribed medicine without advice. Anyone holding the affected lot should speak to their pharmacist or prescriber and follow the instructions issued by the firm.
The recalled product
- Product
- PRIMIDONE (PRIMIDONE)
- Brand
- PRIMIDONE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Anticonvulsant tablet
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot AM251676
- EXP 11/31/2028
Distribution
Distributed nationwide across the United States.
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- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
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- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
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- LowPrimidone Tablets 50 mg Recalled for API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
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