FDA Drug recall D-0617-2024
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottle…
- FDA Drug
- Class II
- terminated
- Published 2024-07-31
On 2024-07-31 the FDA classified a Class II recall of Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottle… by Zydus Pharmaceuticals Usa, citing failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0617-2024 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2024-06-21 |
| Published | 2024-07-31 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Zydus Pharmaceuticals Usa |
| Distribution | US |
Product
Venlafaxine Hydrochloride Extended-Release Capsules, USP 37.5mg, packaged in a) 90-count bottles (NDC 68382-034-16) and b)1000-count bottles (NDC 68382-034-10), Rx only, Mfg. by: Zydus Lifesciences Ltd. Ahmedabad, India; Dist. by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534
Reason
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Identifiers
| ndc | 68382-034-06 |
|---|---|
| ndc | 68382-034-16 |
| ndc | 68382-034-10 |
| ndc | 68382-035-06 |
| ndc | 68382-035-16 |
| ndc | 68382-035-10 |
| ndc | 68382-036-06 |
| ndc | 68382-036-16 |
| ndc | 68382-036-10 |
| code_info | Lot #: a) M213175, Exp. Date 09/2024; b) M213176, Exp. Date 09/2024 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.
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FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa - Erythromycin Tablets, USP, 250 mg, 30 tablets per bottle, Rx only, Manufactured by: Zydus Lifesciences Ltd., Ahmedabad, India, Distributed…
FDA Drug · Class II · 2026-05-27 · Zydus Pharmaceuticals Usa - Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, Rx only, Manufactured by: Softgel Healthcare Pvt
FDA Drug · Class II · 2026-03-18 · Zydus Pharmaceuticals Usa
All Zydus Pharmaceuticals Usa recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0617-2024%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.