Multi-event May 2026 FDA Recall Primidone by Amerisource Health Services Llc
This Multi-event Class III drug recall was voluntarily initiated by Amerisource Health Services Llc on May 1, 2026 for the product Primidone. The FDA reported the reason for recall as cross contamination with other products. The product was distributed Nationwide and the recall is currently ongoing.
Reported Recall Events
Recall Number: D-0536-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
05-01-2026
05-27-2026
63,500 tablets
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amerisource Health Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
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
Batch or Lot Expiration Information
Lot# : 1027583, Exp 09/30/2027
Affected Packages Involved in this Recall
Recall Number: D-0537-2026
Cross contamination with other products: API contaminated with trace amounts of Acemetacin API.
05-01-2026
05-27-2026
225,000 tablets
Recall Profile & Regulatory Data
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Amerisource Health Services LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
USA Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the 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
Batch or Lot Expiration Information
Lot# Lot 1028739, exp 12/31/2027; Lot 1025622, exp 06/30/2027
