Diltiazem Hydrochloride Extended-Release Capsules — Class II drug recall D-0097-2025
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-12-11, distributed nationwide. cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
| Recall number | D-0097-2025 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-11-01 |
| Classified | 2024-12-03 |
| Reported by FDA | 2024-12-11 |
| Distributed | Nationwide (US) |
| Quantity | 4,704 bottles |
| Reason classes | cgmp, specification failure |
| NDC | 16714-0554-01 |
| Lot numbers | 17222452, 17230607 |
| Expiration dates | 2024-11-30, 2025-02-28 |
Product
Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, 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 16714-554-01.
Reason for recall
cGMP Deviations: Presence of N-nitroso-Desmethyl-Diltiazem impurity above FDA recommended interim limit.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0097-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.