Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
buPROPion Hydrochloride Extended-release Tablets Recalled by Sun Pharmaceutical Industries, Inc. Due to Failed Dissolution Specifications; 18 month stability time point
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 Sun Pharmaceutical Industries, Inc. directly.
Affected Products
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c) 500 (NDC 47335-737-13) count bottles, Rx only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical Ind. Ltd., Halol-Baroda Highway, Halol-389 350, Gujarat, India
Quantity: a) 141,068 bottles b) 56,834 bottles c) 61,692 bottles
Why Was This Recalled?
Failed Dissolution Specifications; 18 month stability time point
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharmaceutical Industries, Inc.
Sun Pharmaceutical Industries, Inc. has 40 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report