Diltiazem Hydrochloride Extended-Release Capsules Recalled for CGMP Deviations
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg nationwide due to Current Good Manufacturing Practice (CGMP) deviations. The recall is voluntary and initiated by the firm.
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: The FDA classified this as a Class II recall with no reported illnesses or injuries, and the hazard is a manufacturing-process deviation without evidence of actual product harm. Per the rubric, this qualifies as Moderate (score 2) rather than High, since there is no evidence of the deviation causing adverse health consequences.
Plain-English summary
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottles (NDC# 68462-562-01) distributed nationwide. The recall was initiated on March 13, 2025, and classified by the FDA on April 8, 2025. The specific lots affected are Lot # 17241067 (expiration date May-26) and Lot # 17241628 (expiration date Aug-26).
The reason for recall is Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary recall initiated by the firm and communicated via letter to the FDA.
Diltiazem Hydrochloride is a prescription medication used to treat high blood pressure and angina. Patients currently taking this medication who have bottles from the affected lots should contact their healthcare provider or pharmacist for guidance. Consumers should not discontinue use of their medication without consulting a healthcare professional.
The recalled product
- Product
- DILTIAZEM HYDROCHLORIDE (DILTIAZEM HYDROCHLORIDE)
- Brand
- DILTIAZEM HYDROCHLORIDE
- Manufacturer
- Glenmark Pharmaceuticals Inc., USA
- Hazard
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 (3)
- Lot # 17241067
- exp. date May-26 17241628
- exp. date Aug-26
UPCs (3)
- 0368462562017
- 0368462851012
- 0368462850015
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 39 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 39 products in this recall →Related recalls
Same brand · DILTIAZEM HYDROCHLORIDE
- HighPrescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
FDA (Drugs) · 2024-12-11
- HighDiltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity
FDA (Drugs) · 2024-12-11
- HighDiltiazem Hydrochloride Capsules Recalled Due to N-Nitroso Impurity Above Limits
FDA (Drugs) · 2024-12-11
- HighDiltiazem extended-release capsules recalled for manufacturing impurity
FDA (Drugs) · 2024-12-11
- HighDiltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity
FDA (Drugs) · 2024-12-11
Same manufacturer · Glenmark Pharmaceuticals Inc., USA
See all →- ModerateAzelaic Acid Gel 15% Recalled Over Grainy, Gritty, or Sandy Texture
FDA (Drugs) · 2026-08-05
- ModerateAlyacen 7/7/7 birth control tablets failed total impurities specification
FDA (Drugs) · 2026-06-24
- ModerateOndansetron tablets recalled because blister packs are not fully sealed
FDA (Drugs) · 2026-01-07
- CriticalFrozen chopped methi recalled after testing positive for Salmonella
FDA (Drugs) · 2025-12-17
- ModerateBisoprolol and hydrochlorothiazide tablets recalled over traces of another drug
FDA (Drugs) · 2025-12-10
Same hazard · cgmp deviation
See all →- SevereBaxter Recalls Vasopressin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- HighBaxter Recalls Clindamycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
- ModerateLexia LLC Recalls Broadway Joe's Pain Cream Due to CGMP Deviations
FDA (Drugs) · 2026-09-09
- SevereBaxter Recalls Daptomycin Injection Due to Manufacturing Deviations
FDA (Drugs) · 2026-09-09
Similar recalls
- HighDiltiazem extended-release capsules recalled for manufacturing impurity
FDA (Drugs) · 2024-12-11
- HighPrescription Drug Recall: Diltiazem Extended-Release Capsules Fail Dissolution Test
FDA (Drugs) · 2024-05-01
- HighDiltiazem Hydrochloride Capsules Recalled Due to Failed Dissolution Specifications
FDA (Drugs) · 2024-04-10
- HighPrescription Drug Diltiazem Hydrochloride Recalled for Manufacturing Impurity
FDA (Drugs) · 2024-12-11
- HighDiltiazem Hydrochloride Extended-Release Capsules Recalled for Manufacturing Impurity
FDA (Drugs) · 2024-12-11
- HighDiltiazem Hydrochloride Capsules Recalled Due to Manufacturing Impurity
FDA (Drugs) · 2024-12-11