Diltiazem Hydrochloride Extended-Release Capsules — Class II drug recall D-0430-2024
Ongoing recall by Glenmark Pharmaceuticals Inc., USA, reported 2024-04-10, distributed nationwide. Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th
| Recall number | D-0430-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | Glenmark Pharmaceuticals Inc., USA, Mahwah, NJ, United States |
| Recall initiated | 2024-03-26 |
| Classified | 2024-04-02 |
| Reported by FDA | 2024-04-10 |
| Distributed | Nationwide (US) |
| Quantity | 6,528 bottles |
| Reason classes | specification failure |
| NDC | 68462-0562, 68462-0562-01, 68462-0850, 68462-0850-01, 68462-0851, 68462-0851-01 |
| Lot numbers | 17230304 |
| Expiration dates | 2024-12-31 |
Product
Diltiazem 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
Reason for recall
Failed Dissolution Specifications: Out of Specification (OOS) was reported in test of dissolution at the 12th month time point in long term stability study.
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-0430-2024. 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.