Low risk — use of or exposure to this product is not likely to cause adverse health consequences.
BuPROPion Hydrochloride Extended-Release Tablets (XL) Recalled by Zydus Pharmaceuticals USA Inc Due to Failed Dissolution Specifications; 6 month 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 Zydus Pharmaceuticals USA Inc directly.
Affected Products
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534
Quantity: 16,356 bottles
Why Was This Recalled?
Failed Dissolution Specifications; 6 month time point
Where Was This Sold?
This product was distributed nationwide across all 50 states.
About Zydus Pharmaceuticals USA Inc
Zydus Pharmaceuticals USA Inc has 41 total recalls tracked by RecallDetector.
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Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report