Amneal Pharmaceuticals recalls

Recall found. Amneal Pharmaceuticals is named in FDA Class III recall D-0585-2026 covering Primidone Tablets. Hazard: Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer. Identifying details: Lot AM251676, EXP 11/31/2028. Status: Ongoing.

Models with recalls

Primidone Tablets (1)

All Amneal Pharmaceuticals recalls

FDA Class III · Drug · June 17, 2026

Primidone Tablets recall — Amneal Pharmaceuticals, LLC

Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetacin API due to an issue at the API manufacturer.

Official ID D-0585-2026 · Official record ↗

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FDA — food, drugs, medical devices ↗ (aggregated here)
USDA FSIS — meat, poultry & processed egg products ↗ (not aggregated here)
Recalls.gov — the U.S. government’s all-agency portal ↗

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Compiled from official public-domain government data. Last checked September 7, 2026 at 6:00 AM UTC.