CLASS II ONGOING Drug recall · Reported 16 Apr 2025 · FDA Enforcement Report
Cetirizine Hydrochloride Tablets, USP, 10mg packs recalled
Glenmark Pharmaceuticals Inc., USA is recalling Cetirizine Hydrochloride Tablets, USP, 10mg packs, distributed nationwide in the US. The recall was initiated on 13 Mar 2025 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0348-2025
- FDA event ID
- 96474
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Brand
- Cetirizine Hcl
- Manufacturer
- GLENMARK THERAPEUTICS INC., USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 13 Mar 2025
- FDA classified
- 8 Apr 2025
- Reported
- 16 Apr 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Allergy Medication
Timeline
| 13 Mar 2025 | Recall initiated by company | |
| 8 Apr 2025 | Classified by FDA | +26 days |
| 16 Apr 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations
Product as listed by the FDA
Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by: Amazon. NDC# 72657-129-35
Where it was distributed
U.S. Nationwide
Stores named: Amazon, Online Retailers
Questions about this recall
Why was it recalled?
CGMP Deviations
Which lots are affected?
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
Where was it sold?
U.S. Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
38 other products · FDA event 96474More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalledBisoprolol Fumarate And Hydrochlorothiazide | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Cetirizine recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Cetirizine Hydrochloride Tablets USP 5 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine Hydrochloride Tablets USP 10 mg recalled by JB Chemicals andCetirizine Hydrochloride | JB Chemicals and Pharmaceuticals | Other | Nationwide |
| Drug | CLASS III | Cetirizine hydrochloride recalled by A-S Medication SolutionsCetirizine | A-S Medication Solutions | Other | 4 states |
| Drug | CLASS II | Cetirizine Hydrochloride Tablets, 10 mg recalled by Cardinal Health | Cardinal Health | Manufacturing (CGMP) Deviations | FL, GA, SC |