Diltiazem Hydrochloride Capsules Recalled Due to Nitrosamine Impurity
Glenmark Pharmaceuticals is recalling Diltiazem Hydrochloride capsules because they contain a chemical impurity above safe limits. About 7,296 bottles were distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: FDA Class II recall involving a manufacturing defect with N-nitroso-Desmethyl-Diltiazem impurity above FDA's recommended interim limit. No illnesses or injuries are reported. This constitutes a risk-of-harm pharmaceutical product without yet-reported injury.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP 120mg, distributed nationwide in the United States. Approximately 7,296 bottles are affected. The product was manufactured by Glenmark Pharmaceuticals Limited in Pithampur, India, and distributed by Northstar Rx LLC in Memphis, Tennessee.
The recall is due to a manufacturing quality defect: the presence of N-nitroso-Desmethyl-Diltiazem, a chemical impurity, at levels exceeding FDA's recommended interim limit. This represents a deviation from current Good Manufacturing Practice (cGMP) standards.
The affected lots are: #17222547 (expiration date 11/30/2024) and #17230598 (expiration date 02/28/2025). Patients currently taking this medication should contact their healthcare provider or pharmacist for guidance. Do not discontinue use without medical advice. Consumers with unused product should return it to their pharmacy.
The recalled product
- Product
- DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Category
- Drug
- Affected units
- 7,296
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 (5)
- Lot #:17222547
- Exp. Date
- 11/30/2024
- 17230598
- Exp. Date 02/28/2025
UPCs (3)
- 0316714555010
- 0316714553016
- 0316714554013
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 6 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 6 products in this recall →Related recalls
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