Glenmark Pharmaceuticals Inc., USA Recall: Diltiazem Hydrochloride Extended-Release Capsul
Glenmark Pharmaceuticals Inc., USA Recall: Diltiazem Hydrochloride Extended-Release Capsul is one of 9,000 recalls in the RecallGuard dataset. Key details — Recalling firm: Glenmark Pharmaceuticals Inc., USA; Product: Diltiazem Hydrochloride Extended-Release Capsules, USP 90mg, Twice-a-Day Dosage, Rx Only, 100 Capsules
| Recalling firm | Glenmark Pharmaceuticals Inc., USA |
|---|---|
| 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. |
| Classification | Class II (moderate — may cause temporary or reversible health consequences) |
| Status | Ongoing |
| Distribution | Nationwide in the USA |
| Recall initiated | 20241101 |
| Recall number | D-0097-2025 |
| Category | drug |
| State | NJ |
| Country | United States |
$29/mo
Try RecallGuard →