Cetirizine Hcl Tablet
FDA Recall NDC 72657-129
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 Cetirizine Hcl (NDC 72657-129). A significant event, classified as Class II, was initiated on Mar 13, 2025 by Glenmark Therapeutics Inc., Usa. The reported reason for this action was: "CGMP Deviations"
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
CGMP Deviations
Mar 13, 2025
Apr 16, 2025
N/A
Recall Profile & Regulatory Data
Event ID
96474
Classification
Class II
Enforcement Status
Ongoing
Recalling Firm
Glenmark Pharmaceuticals Inc., USA
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Product Description
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Batch or Lot Expiration Information
Lot# 17231980, ep.. date Aug-25 Amazon 17232044, ep.. date Aug-25 Walmart 17241436, ep.. date Jul-26 Amazon 17241437, ep.. date Jul-26 Amazon 17241455, ep.. date Jul-26 Amazon 17241456, ep.. date Aug-26 Amazon 17241457, ep.. date Aug-26 Amazon 17241892, ep.. date Oct-26 Amazon 17241893, ep.. date Oct-26 Amazon
Affected Packages Involved in this Recall
72657-128-30Product
72657-128-45Product
72657-128-60Product
72657-128-70Product
72657-128-90Product
72657-128-08Product
72657-128-14Product
72657-128-15Product
72657-128-18Product
72657-128-24Product
72657-128-03Product
72657-128-35Product
72657-128-04Product
72657-128-81Product
72657-128-82Product
72657-128-84Product
72657-128-86Product
72657-128-41Product
72657-129-30Product
72657-129-45Product
72657-129-60Product
72657-129-70Product
72657-129-90Product
72657-129-08Product
72657-129-14Product
72657-129-15Product
72657-129-18Product
72657-129-24Product
72657-129-03Product
72657-129-35Product
72657-129-04Product
72657-129-81Product
72657-129-82Product
72657-129-84Product
72657-129-86Product
72657-129-41Product
72657-130-05Product
72657-131-89Product
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.
