Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
buPROPion Hydrochloride Extended-¿release Tablets USP (SR) Recalled by Sun Pharma Global Fze Due to Failed Dissolution Specification: During analysis of the 18...
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 Pharma Global Fze directly.
Affected Products
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed by: Sun Pharmaceutical Industries Inc. Cranbury, NJ 08512, Manufactured By: Sun Pharmaceutical Ind. Ltd., Halol Baroda Highway, Halol 389 350, Gujarat, India, NDC 47335-738-86
Quantity: 35,235 bottles
Why Was This Recalled?
Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed that the drug release results at the 4 hour time point are not meeting specifications.
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Sun Pharma Global Fze
Sun Pharma Global Fze has 4 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report