FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass III · Drug · Recalled May 27, 2026

Primidone Tablets recall — Amerisource Health Services LLC

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

Class III: not likely to cause adverse health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0537-2026
Brand
Amerisource Health Services
Classification
Class III
Units affected
225,000 tablets
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

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

Affected products

Companies & origin

Recalling firm location
Columbus, OH, United States
Firm address
2550 John Glenn Ave Ste A, 43217-1188

Identifying details (verbatim from the notice)

Product codes / lots
Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
Distribution
USA Nationwide
Firm notified the public via
Letter
FDA event ID
98884
Recall initiated
May 1, 2026
FDA classified
May 18, 2026
FDA report date
May 27, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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