Class III โ€” Low Risk

Low risk โ€” use of or exposure to this product is not likely to cause adverse health consequences.

BuPROPion Hydrochloride Extended-release Tablets Recalled by Jubilant Cadista Pharmaceuticals, Inc. Due to Failed Impurities/Degradation Specifications: high out of specification results...

Date: April 8, 2016
Company: Jubilant Cadista Pharmaceuticals, Inc.
Status: Terminated
Source: FDA (Drug)

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 Jubilant Cadista Pharmaceuticals, Inc. directly.

Affected Products

BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, packaged in a) 60-count bottles (NDC 59746-316-60) and b) 100-count bottles (NDC 59746-316-01), Rx only, Manufactured by: Julibant Life Sciences Ltd., Roorkee-247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, USA.

Quantity: 81,077 bottles

Why Was This Recalled?

Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.

Where Was This Sold?

This product was distributed nationwide across all 50 states.

Affected (51 states)Not affected

About Jubilant Cadista Pharmaceuticals, Inc.

Jubilant Cadista Pharmaceuticals, Inc. has 29 total recalls tracked by RecallDetector.

Related Recalls

Data sourced from the FDA (Drug). Last updated March 26, 2026. View original report