Class II · Moderate risk Ongoing
Bupropion Hydrochloride Extended-Release Tablets USP (XL), 300 mg, 30-count bottles, Rx Only, Mfd. by: Graviti Pharmaceuticals…
Reason Failed Tablet/Capsule Specifications
Is Bupropion recalled?
44 FDA recalls mention Bupropion. The most recent are listed below.
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bupropion.
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-release Tablets USP (XL) Once-Daily, 150 mg, 100 Tablets (10 x 10) per carton, Rx Only…
Reason Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Class II · Moderate risk Ongoing
buPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150mg, 30-count bottles, Rx Only, Manufactured for: Rising Pharma…
Reason Presence of Foreign Tablets/Capsules
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets, USP (SR) 200 mg, 60 Tablets bottle, Distributed by: Sun Pharmaceutical…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
Bupropion Hydrochloride Extended-Release Tablets USP (SR), 150 mg, 60 tablets bottle, Rx Only, Distributed by: Sun Pharmaceutical…
Reason Failed Dissolution Specifications
Class II · Moderate risk Terminated
BuPROPion Hydrochloride Tablets, USP 75 mg, 100 Tablets (10 x 10) per carton, Rx Only, Distributed by: American Health Packaging…
Reason Failed Impurities/Degradation Specifications
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 200 mg, 60-count bottle, Rx only Distributed by: Sun Pharmaceutical…
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be…
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count…
Reason Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be…
Class II · Moderate risk Terminated
bupropion Hydrochloride Tablets, USP 75 mg 100 Tablets Rx only NDC 23155-191-01 Manufactured for: Heritage Pharmaceuticals Inc…
Reason CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 150 mg, a) 30 count (NDC 59746- 758-30) & b) 90 count (NDC…
Reason Failed Dissolution Specifications; 9-monthstability timepoint
Class III · Low risk Terminated
Contrave (naltrexone HCl and bupropion HCl). Extended-Release Tablets, 8mg/90 mg, 120-count bottles, Rx only, Distributed by…
Reason Container packaging defect.
Class III · Low risk Terminated
Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA…
Reason Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18…
Class III · Low risk Terminated
Contrave (naltrexone HCl and bupropion HCl) Extended-Release Tablets, 8 mg/90 mg, 120-count bottle, Rx only, Distributed by…
Reason Defective Container: Customer complaints of punctures in the bottle.
Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07)…
Reason Failed Dissolution Specifications; during stability testing
Class III · Low risk Terminated
buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560…
Reason Failed Dissolution Specifications; during stability testing
Class III · Low risk Terminated
BuPROPion HCL Tablets, USP, 75 mg, packaged as UD 100 tablets (10x10), Rx Only, Mfg by: Sandoz Inc., 508 Carnegie Center, Suite…
Reason Failed Moisture Limits: Product tested out-of-specification for moisture content.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, 60 count bottles, Rx only, Distributed by: Sun Pharmaceutical…
Reason Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, a) 60 (NDC 47335-737-86), b) 100 (NDC 47335-737-88) and c)…
Reason Failed Dissolution Specifications; 18 month stability time point
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count…
Reason Failed Dissolution Specifications; 6 month time point
Class III · Low risk Terminated
Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle…
Reason Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-release Tablets, USP (SR), 150 mg, Twice-A-Day, in 60 count bottles, Rx only, Distributed by…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
buPROPion Hydrochloride Extended-Release Tablets, USP (XL), 300mg, 500-count bottle, Rx only, Manufactured by: Cadila Healthcare…
Reason Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-Release Tablets, USP (XL) 300 mg, Rx Only, 500-count bottles, Manufactured by Cadila…
Reason Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Class III · Low risk Terminated
buPROPion Hydrochloride Extended Release Tablets USP (SR) 150 mg Rx Only 60 tablets Distributed by Sun Pharmaceutical Industries…
Reason Failed Dissolution Specifications
Class III · Low risk Terminated
BuPROPion Hydrochloride Extended-release Tablets, USP (SR), 200 mg, packaged in a) 60-count bottles (NDC 59746-317-60) and b)…
Reason Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
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