Meclizine Hydrochloride Tablet
FDA Recall NDC 60687-730
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 1 recorded enforcement report(s) associated with Meclizine Hydrochloride (NDC 60687-730). A significant event, classified as Class II, was initiated on Mar 16, 2026 by American Health Packaging. The reported reason for this action was: "Failed tablet specifications."
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
This recall is currently ONGOING. Healthcare providers and patients are advised to check their inventory immediately against the affected codes provided below.
Reported Recall Events
Class II Ongoing
Failed tablet specifications.
Mar 16, 2026
Apr 01, 2026
697 cartons
Recall Profile & Regulatory Data
Event ID
98526
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Amerisource Health Services LLC
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
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
Affected Packages Involved in this Recall
60687-775-11Product
60687-775-01Product
60687-775-65Product
60687-730-11Product
60687-730-01Product
60687-730-65Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
