March 2026 FDA Recall Meclizine Hydrochloride by Amerisource Health Services Llc
D-0418-2026 - Failed tablet specifications.
This Class II drug recall was voluntarily initiated by Amerisource Health Services Llc on March 16, 2026 for the product Meclizine Hydrochloride. The FDA reported the reason for recall as failed tablet specifications.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0418-2026
Failed tablet specifications.
03-16-2026
04-01-2026
697 cartons
Recall Profile & Regulatory Data
Class II - is a situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
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.
U.S. Nationwide
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Meclizine Hydrochloride Tablets, USP 12.5 mg, (a) 50 Tablets [5 x 10] (NDC 60687-775-65) (b) 12.5 mg Individual Dose ( NDC 60687-775-11), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio, 43217.
Batch or Lot Expiration Information
Lot# 1024852; Exp 9/30/2026
