BUPROPION HYDROCHLORIDE

Generic: BUPROPION HYDROCHLORIDE

Aurobindo Pharma LimitedManufacturer
ORALRoute
BUPROPION HYDROCHLORIDEActive Substance
2026-07-21Original Approval

BUPROPION HYDROCHLORIDE is FDA application ANDA216051, sponsored by AUROBINDO PHARMA LTD. Any recalls listed below come from FDA drug enforcement reports, and reaction counts are the number of FAERS adverse event reports that mention the drug and that reaction; a report does not prove the drug caused it.

Recalls

Class II2025-09-15
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceu

Failed Tablet/Capsule Specifications

Class II2024-06-24
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only,

Failed Dissolution Specifications; the product is dissolving faster than the specified limits.

Class III2013-11-15
BuPROPion Hydrochloride Extended-Release Tablet (XL) 150mg, Rx only, a) 30 count bottle(NDC 0591-3331-30), b) 90 count b

Failed Dissolution Specifications: Failed stability testing for dissolution test at 18 months.

Class III2016-06-27
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical In

Failed Dissolution Specifications

Class III2016-12-20
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88)

Failed Dissolution Specifications; 18 month stability time point

Class III2015-07-17
buPROPion Hydrochloride Extended-¿release Tablets USP (SR), 200 mg, Twice-A-Day, Rx Only, 60 count Bottle, Distributed

Failed Dissolution Specification: During analysis of the 18 month long term stability testing, it wa

Class III2018-03-15
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-

Failed Dissolution Specifications; during stability testing

Class III2022-04-29
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmace

Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found w

Class III2023-10-04
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharm

Failed Dissolution Specifications

Class III2023-11-22
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical

Failed Dissolution Specifications

Top Reported Reactions

1
DRUG INEFFECTIVE
2,316 reports
2
HEADACHE
1,632 reports
3
DEPRESSION
1,512 reports
4
FATIGUE
1,500 reports
5
NAUSEA
1,355 reports
6
OFF LABEL USE
1,156 reports
7
PAIN
1,049 reports
8
ANXIETY
1,019 reports
9
DRUG INTERACTION
892 reports
10
COMPLETED SUICIDE
881 reports