buPROPion Hydrochloride Extended-¿release Tablets USP — Class III drug recall D-1345-2015

Terminated recall by Sun Pharma Global Fze, reported 2015-08-26, distributed nationwide. Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it was noticed

Recall number	`D-1345-2015`
Product type	Drug
Classification	Class III
Status	Terminated
Voluntary or mandated	Voluntary
Recalling firm	Sun Pharma Global Fze, Sharm, United Arab Emirates
Recall initiated	2015-07-17
Classified	2015-08-14
Reported by FDA	2015-08-26
Terminated	2016-03-22
Distributed	Nationwide (US)
Quantity	35,235 bottles
Reason classes	specification failure
NDC	`47335-0736`, `47335-0736-08`, `47335-0736-13`, `47335-0736-86`, `47335-0736-88`, `47335-0737`, `47335-0737-08`, `47335-0737-13`, `47335-0737-86`, `47335-0737-88`, `47335-0738`, `47335-0738-08`, `47335-0738-13`, `47335-0738-86`, `47335-0738-88`
Lot numbers	`JKM4152A`, `JKM4737A`, `JKM5270A`
Expiration dates	`2015-08`

Product

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

Reason for recall

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.

Machine access

This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-1345-2015. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.

Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.