[pending] PRIMIDONE (PRIMIDONE)
Pending LLM rewrite. Source: FDA_DRUG D-0585-2026.
What this means for you
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: Pending LLM scoring against the rubric.
Plain-English summary
Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.
The recalled product
- Product
- PRIMIDONE (PRIMIDONE)
- Brand
- PRIMIDONE
- Manufacturer
- Amneal Pharmaceuticals, LLC
- Category
- Drug — Drugs
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.
Related recalls
Same brand · PRIMIDONE
- LowPrimidone Tablets Recalled Due to Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- ModeratePrimidone Tablets Recalled Due to API Cross-Contamination
FDA (Drugs) · 2026-05-27
- LowPrimidone Tablets Recalled for Cross-Contamination with Acemetacin
FDA (Drugs) · 2026-05-27
- 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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