Potential health hazard — use of or exposure to this product may cause temporary or medically reversible adverse health consequences.
Venlafaxine Hydrochloride Extended-Release Tablets Recalled by Caraco Pharmaceutical Laboratories, Ltd. Due to Failed Dissolution Specifications: Stability results found the product...
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 Caraco Pharmaceutical Laboratories, Ltd. directly.
Affected Products
Venlafaxine Hydrochloride Extended-Release Tablets, 37.5 mg, packaged in a) 30-count bottles (NDC 41616-760-83, UPC 3 41616 76083 5); and b) 90-count bottles (NDC 41616-760-81, UPC 3 41616 76081 1), Rx only, Distributed by: Caraco Pharmaceutical Laboratories, Ltd., 1150 Elijah McCoy Drive, Detroit, MI 48202; Manufactured at: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India.
Quantity: 91,777 bottles
Why Was This Recalled?
Failed Dissolution Specifications: Stability results found the product did not meet the drug release dissolution specifications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Caraco Pharmaceutical Laboratories, Ltd.
Caraco Pharmaceutical Laboratories, Ltd. has 10 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report