CLASS II ONGOING Drug recall · Reported 11 Dec 2024 · FDA Enforcement Report
Diltiazem Hydrochloride Extended-Release Capsules recalled
Glenmark Pharmaceuticals Inc., USA is recalling Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, distributed nationwide in the US. The recall was initiated on 1 Nov 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0096-2025
- FDA event ID
- 95660
- Recalling firm
- Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 1 Nov 2024
- FDA classified
- 3 Dec 2024
- Reported
- 11 Dec 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 1 Nov 2024 | Recall initiated by company | |
| 3 Dec 2024 | Classified by FDA | +32 days |
| 11 Dec 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Diltiazem Hydrochloride Extended-Release Capsules, USP 60 mg, Twice-a-Day Dosage, Rx Only, 100 Capsules per bottle, Mfd for: Northstar Rx LLC, Memphis, TN, Mfd by: Glenmark Pharmaceuticals Limited, Pithampur, Madhya Pradesh India, NDC 16714-553-01.
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Which lots are affected?
Lot #: 17222544, Exp 11/30/2024.
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
5 other products · FDA event 95660This product is part of a recall event; the main page for the event is Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg recalled | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide | |
| CLASS II | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide | |
| CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalled | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide | |
| CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide | |
| CLASS II | Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
More recalls from Glenmark Pharmaceuticals Inc., USA
All 141| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Azelaic Acid Gel, 15% tubes, For Topical Use only recalledAzelaic Acid | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alyacen 7/7/7, Norethindrone recalled by Glenmark PharmaceuticalsAlyacen 1/35 | Glenmark Pharmaceuticals Inc., USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Ondansetron Orally Disintegrating Tablets, USP, 4mg recalledOndansetron | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
| Drug | CLASS III | Nebivolol Tablets, 20 mg recalled by Glenmark PharmaceuticalsNebivolol | Glenmark Pharmaceuticals Inc., USA | Other | Nationwide |
| Drug | CLASS III | Bisoprolol Fumarate and Hydrochlorothiazide Tablets recalled | Glenmark Pharmaceuticals Inc., USA | Packaging Defects | Nationwide |
Other Diltiazem recalls
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules 12HR recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules, USP 90 mg recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules recalled | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Diltiazem Hydrochloride Extended-Release Capsules, USP 120 mg recalledDiltiazem Hydrochloride | Glenmark Pharmaceuticals Inc., USA | Nitrosamine Impurity | Nationwide |