American Health Packaging recalls primidone tablets over contamination with trace amounts of another ingredient
The notice says the active ingredient in these primidone tablets, 50 mg and 250 mg, was contaminated with trace amounts of Acemetacin active ingredient through cross contamination with other products.
What to do
The notice does not give instructions. Read the official notice for details.
Note from Recalled Today: Don't stop taking a prescribed medicine before you talk to your pharmacist or doctor.
Recall 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; Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC…
- Hazard
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Units
- 225,000 tablets; 63,500 tablets
- Where sold
- USA Nationwide
- FDA classification
- Class III · Ongoing
- Classified by FDA
- May 18, 2026
- Recall started
- May 1, 2026
- FDA enforcement report
- May 27, 2026
- Identifiers
- Codes: Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
- FDA recall number: D-0537-2026
- Codes: Lot#: 1027583, Exp 09/30/2027
- FDA recall number: D-0536-2026
The headline, summary and steps above are written in plain English from the official notice below. Identifiers are copied exactly as the agency published them. Always check the official notice before you act.
Official notice
The notice's own wording from FDA.
- 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 | Primidone Tablets, USP, 250 mg, 100 Tablets (10 x 10 unit dose blister) per carton, Rx only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Carton NDC: 68084-203-01; Individual Dose NDC: 68084-203-11
- Reason for recall
- Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
- Classification
- Class III (Ongoing)
- Distribution
- USA Nationwide
- Quantity
- 225,000 tablets; 63,500 tablets
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