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  5. FDA Recall: Diltiazem Hydrochloride

FDA Recall Diltiazem Hydrochloride

View Recall Number, Date, Reasons, Quantity

FDA Recall Enforcement Reports

The most recent Recall Enforcement Report that covers this product was initiated on March 13th, 2025 and classified as a Class II recall due to cgmp deviations This recall is currently ongoing, and the associated recall number is recall number is D-0342-2025. It pertains to Diltiazem Hydrochloride identified by 68462-851.

Recall Number Recall Initiation Date Report Date Quantity Product Description Recall Reason Status
D-0342-202503-13-202504-16-2025N/ADiltiazem Hydrochloride Extended-Release Capsules 12HR 120mg, 100-count bottle, Rx, Only. Manufactured by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh 454775, India, Manufactured for: Glenmark Pharmaceuticals Inc. USA, Mahwah, NJ 07430. NDC# 68462-562-01CGMP DeviationsOngoing
D-0095-202511-01-202412-11-202425584 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Rx Only, 100 Capsules, Manufactured for: Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ 07430, Product of India, NDC 68462-562-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0093-202511-01-202412-11-202434848 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-850-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0094-202511-01-202412-11-202412,864 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 90 mg, Rx Only, 100 Capsules, Manufactured for : Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, Product of India, NDC 68462-851-01.cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.Ongoing
D-0472-202404-17-202405-01-20243,264 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01.Failed Dissolution SpecificationsOngoing
D-0430-202403-26-202404-10-20246,528 bottlesDiltiazem Hydrochloride Extended-Release Capsules, USP 120 mg, Twice-a-Day Dosage, 100 Capsules per bottle, Rx Only, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ, 07430, Product of India, NDC 68462-562-01Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.Ongoing

What is a Recall Enforcement Report?

A Recall Enforcement Report is an official publication by the FDA that documents all classified drug recalls.

When a company initiates a product removal or correction, the FDA evaluates whether the action meets the criteria for a recall. If it does, the FDA assesses the level of public health risk and assigns a recall classification (Class I, II, or III). Once classified, the recall is published in the Enforcement Report, which includes details such as the product name, affected lot numbers, reason for recall, and scope of distribution.

The Enforcement Report ensures transparency and allows the public and healthcare professionals to stay informed about products that may present a health or safety concern.

Understanding Recall Reports

The recall information provided on this website is sourced directly from official U.S. Food and Drug Administration (FDA) data. It is important to understand that most product recalls are limited in scope and typically involve only specific lots or batches of a product that have been identified as potentially defective or non-compliant with regulatory standards.

Recalls may be initiated voluntarily by the manufacturer or distributor, or they may be mandated by the FDA when a product is found to pose a health risk. A recall does not necessarily mean that all units of a product are unsafe.

If you have concerns about the safety of a medication or healthcare product you are using, it is strongly recommended that you verify the product’s lot number and consult your pharmacist or healthcare provider to determine whether your specific product is affected by the recall.