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Recall Observatory FDA recall evidence

Drug 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.

D-0418-2026

March 16, 2026

Class II

Product summary

Firm
Amerisource Health Services LLC
Event
Event 98526
Status
Ongoing
Classification
Class II
Quantity
697 cartons
Official record key
drug-enforcement:D-0418-2026

Official wording

Reason: Failed tablet specifications.

Code information: Lot #1024852; Exp 9/30/2026

Distribution pattern: U.S. Nationwide

Derived failure modes

  • Unknown

    reason.no_named_rule · v1.0.0

    Failed tablet specifications.