Glenmark Pharmaceuticals Inc., USA recalls Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc.,…
CGMP Deviations
Read the official notice →- Date
- 2025-04-16
- Country
- United States
- Brand
- Glenmark Pharmaceuticals
- Product
- Cetirizine Hydrochloride Tablets, USP, 10mg, 365-count packs, Rx Only, Manufactured for: Glenmark Therapeutics Inc., Distributed by:…
- Classification
- Class II
- Units
- U.S. Nationwide
- Category
- Drugs & medical
- Source
- FDA · Drug
Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer
What to do
- Check the product name, strength and lot number against the official notice.
- Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
- Ask the pharmacy or supplier about a replacement or refund.
General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.
More Glenmark Pharmaceuticals recalls
- 2025-06-18
US
Glenmark Pharmaceuticals Inc., USA recalls Ezetimibe and Simvastatin Tablets, 10mg/40mg, 90-count bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., Plot…
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for related substances test for Anhydro Simvastatin at the 06-month time point during long-term stability study.
- 2025-06-04
US
Glenmark Pharmaceuticals Inc., USA recalls Theophylline (Anhydrous) Extended-Release Tablets, 600 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Glenmark…
OOS results reported for the Dissolution (by UV) test.
US
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets USP 25 mg, 500 -Count bottle, Rx Only, Manufactured by: Glenmark Pharmaceuticals Ltd., Manufactured for…
CGMP Deviations; presence 'N-Nitroso Carvedilol I' Impurity above the recommended acceptable intake limit
- 2025-04-09
US
Glenmark Pharmaceuticals Inc., USA recalls chlorproMAZINE Hydrochloride Tablets, USP 100 mg, Rx Only, 100 Tablets per bottle, Manufactured for: Glenmark Pharmaceuticals…
CGMP deviations: presence of N-Nitroso-Desmethyl Chlorpromazine impurity above the recommended interim limit.
- 2025-02-26
US
Glenmark Pharmaceuticals Inc., USA recalls Atomoxetine Capsules, USP, 80 mg, 30 capsule bottles, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., NJ, USA,…
CGMP Deviations: presence of N-Nitroso Atomoxetine Impurity above the FDA recommended limit.
- 2025-02-12
US
Glenmark Pharmaceuticals Inc., USA recalls Carvedilol Tablets, USP, 12.5 mg, Rx only, a)500 Tablets, NDC 68462-164-05; b) 100 Tablets, NDC 68462-164-01, Manufactured…
CGMP Deviations:N-Nitroso Carvedilol I impurity (NNCI-I) were found to be failing per current FDA recommended limit.
Other drugs & medical recalls in the United States
- 2025-04-16
US
Alchemee, LLC recalls Proactiv Skin Smoothing Exfoliator (Benzoyl Peroxide 2.5%), Packaged as a) 6 fl. oz. (177.4 mL), UPC 7 35786 01528 2; b) 0.33 OZ (9.45g),…
Chemical contamination: Presence of benzene
US
Somerset Therapeutics Private Limited recalls Haloperidol Decanoate Injection 50mg/mL, 1mL Single-Dose Vial, Rx Only, Manufactured by: Somerset Therapeutics Limited,…
Lack of Assurance of Sterility: Media fill with bacterial contamination
US
B. Braun Medical Inc recalls 0.9% Sodium chloride Irrigation USP, Isotonic Solution for Irrigation, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical, Inc.,…
Presence of Particulate Matter
FDA · DrugB. Braun Medical IncProduct was distributed to 12 distributors who may have further distributed…Official notice →US
ASEGUA THERAPEUTICS LLC recalls Sofosbuvir and Velpatasvir, 400 mg/100 mg tablets, 28 tablets: 2x14 blister cards, Rx Only, Manufactured for: Asegua Therapeutics LLC an…
Defective Container: blister packs not properly sealed resulting in tablets being loose in the carton.
US
US
Zydus Pharmaceuticals (USA) Inc recalls Venlafaxine Tablets, USP, 75 mg, 100 Tablets, Rx only, Mfg. by: Zydus Lifesciences Ltd, Ahmedabad, India, Dist. by: Zydus…
Presence of Foreign Substance: Product complaint received for the presence of foreign material embedded resembling a metal shaving in one tablet.