Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Venlafaxine Hydrochloride Extended-Release Capsules Recalled by Zydus Pharmaceuticals (USA) Inc Due to Failed Dissolution Specifications: Out-of-specification results observed for dissolution...
What You Should Do
Stop using this product immediately. Do not consume, use, or distribute it.
Return the product to the place of purchase for a full refund. If you have questions, contact Zydus Pharmaceuticals (USA) Inc directly.
Affected Products
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
Quantity: a) 13,128 bottles; b) 252 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Out-of-specification results observed for dissolution testing at the 8-hour and 12-hour pull intervals.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals (USA) Inc
Zydus Pharmaceuticals (USA) Inc has 51 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report