FDA recall D-0537-2026

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

Reason for recall

Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.

Distribution

USA Nationwide

Key facts

Status

Ongoing

Initiation date

2026-05-01

Report date

2026-05-27

Voluntary/Mandated

Voluntary: Firm initiated

Location

Columbus, OH, United States

Primary source

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0537-2026