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Drug FDA Class II Ongoing cGMP deviation

Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35

Glenmark Pharmaceuticals Inc., USA Published Apr 16, 2025

Risk level

Class II

May cause a temporary or reversible health problem; slight chance of serious harm.

Severity score 60/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Glenmark Pharmaceuticals Inc., USA or your place of purchase with questions, and see the source record below for full details.
Reason for recall

CGMP Deviations

Affected products (1)

Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35

CETIRIZINE HCL · N/A

NDC: 72657-128, 72657-129, 72657-130, 72657-131, 72657-128-30, 72657-128-45, 72657-128-60, 72657-128-70, 72657-128-90, 72657-128-08, 72657-128-14, 72657-128-15, 72657-128-18, 72657-128-24, 72657-128-03, 72657-128-35, 72657-128-04, 72657-128-81, 72657-128-82, 72657-128-84, 72657-128-86, 72657-128-41, 72657-129-30, 72657-129-45, 72657-129-60, 72657-129-70, 72657-129-90, 72657-129-08, 72657-129-14, 72657-129-15, 72657-129-18, 72657-129-24, 72657-129-03, 72657-129-35, 72657-129-04, 72657-129-81, 72657-129-82, 72657-129-84, 72657-129-86, 72657-129-41, 72657-130-05, 72657-131-89
Lot codes: 17231980
Code info: 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 areas

Nationwide

Timeline

  1. Initiated
    Mar 13, 2025
  2. Published
    Apr 16, 2025
Recall number
D-0348-2025
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.