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.
What this means for you
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
- cgmp-deviation
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.
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