Glenmark Pharmaceuticals Recalls Telmisartan/Hydrochlorothiazide Due to Defective Blister Packs
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Telmisartan and Hydrochlorothiazide tablets due to complaints of defective blister packs that are difficult to open and cause tablets to break during removal.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 2/5 (Moderate).
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA Class II recall with defective container affecting product usability and integrity. No illnesses or injuries reported. The packaging defect, while not immediately hazardous, warrants a Moderate classification per the FDA's Class II designation.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling specific lots of Telmisartan and Hydrochlorothiazide Tablets USP, 80 mg/12.5 mg, in 30-tablet blisters. The company has initiated this recall due to complaints regarding the defective container—specifically, the blister packs are difficult to open and tablets break while being removed from the package.
The affected lots are 17210929 and 17210930 (expiring 05/2023), lot 17211203 (expiring 06/2023), and lots 17211643, 17211646, and 17211649 (expiring 08/2023). The product was distributed nationwide. The product is manufactured by Glenmark Pharmaceuticals Ltd. in Pithampur, India, and distributed by Glenmark Pharmaceuticals Inc., USA, in Mahwah, New Jersey (NDC 68462-841-13).
Consumers and healthcare providers with affected product should contact Glenmark Pharmaceuticals Inc., USA for further information regarding recall procedures and replacement product availability.
The recalled product
- Product
- TELMISARTAN AND HYDROCHLOROTHIAZIDE (TELMISARTAN AND HYDROCHLOROTHIAZIDE)
- Brand
- TELMISARTAN AND HYDROCHLOROTHIAZIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug — Blister Packaging
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (6)
- Lots 17210929 & 17210930
- Exp Date 05/2023
- Lot 17211203
- Exp Date 06/2023 & Lots 17211643
- 17211646 & 17211649
- Exp Date 08/2023
UPCs (3)
- 0368462842133
- 0368462841136
- 0368462840139
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Glenmark Pharmaceuticals Inc., USA under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
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