Bupropion Hydrochloride Extended-Release Tablets USP
Failed Tablet/Capsule Specifications
Yes — there is an active recall. 3 ongoing FDA recalls mention Bupropion (44 total). Check the affected lots below.
Most common reason: Dissolution failure (23 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Bupropion. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Failed Tablet/Capsule Specifications
Failed Dissolution Specifications; the product is dissolving faster than the specified limits.
Presence of Foreign Tablets/Capsules
Failed Dissolution Specifications
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
Presence Of Foreign Substance: Customer complaint for the presence of dark, gritty substance found within the bottle which was determined to be activated carbon from the desiccant canister inside the bottle.
CGMP Deviations: Intermittent exposure to temperature excursion during storage.
Failed Dissolution Specifications; 9-monthstability timepoint
Container packaging defect.
Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size.
Defective Container: Customer complaints of punctures in the bottle.
Failed Dissolution Specifications; during stability testing
Failed Dissolution Specifications; during stability testing
Failed Moisture Limits: Product tested out-of-specification for moisture content.
Failed Dissolution Specifications; 18 month stability time point
Failed Dissolution Specifications; 18 month stability time point
Failed Dissolution Specifications; 6 month time point
Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.
Failed Dissolution Specifications
Failed dissolution specifications - the out of specification result for dissolution was identified during 3 month stability testing.
Failed Dissolution Specifications: Product did not meet dissolution specification at an intermediate time point.
Failed Dissolution Specifications
Failed Impurities/Degradation Specifications: high out of specification results for one of the known degradation products, m-chlorobenzoic acid.
Free recall alerts
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.