Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
RxRecalls Get alerts

National Drug Code

Is NDC 47335-0738-86 recalled?

Bupropion hydrochloride · 60 TABLET, FILM COATED, EXTENDED RELEASE in 1 BOTTLE (47335-738-86)

Yes — this exact package was recalled

5 FDA recalls name the code 47335-0738-86 directly. A recall still applies to particular lot numbers — compare the lot on your package with the FDA notice below, and talk to your pharmacist before stopping a prescribed medication.

Active ingredient
Bupropion hydrochloride
Strength
BUPROPION HYDROCHLORIDE 200 mg/1
Form
Tablet, Film Coated, Extended Release · Oral
Labeler
Sun Pharmaceutical Industries, Inc.
Type
Human Prescription Drug
Product code
47335-0738

Recalls naming this package

Class III · Low risk

buPROPion Hydrochloride Extended-Release Tablet

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.

Terminated Particulate / foreign matter Sun Pharmaceutical Industries INC NDC 47335-738-86 D-0858-2022
Class III · Low risk

buPROPion Hydrochloride Extended-¿release Tablets USP

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.

Terminated Dissolution failure Sun Pharma Global Fze NDC 47335-738-86 D-1345-2015
Class II · Moderate risk

buPROPion HCl ER Tablet

Labeling: Label Mixup; buPROPion HCl ER Tablet, 200 mg may be potentially mislabeled as AMANTADINE HCL, Capsule, 100 mg, NDC 00781204801, Pedigree: W002726, EXP: 6/6/2014.

Terminated Labeling / mix-up Aidapak Services, LLC D-573-2014

Where to find this code. The NDC is printed on the pharmacy label and on the manufacturer's carton, usually as three groups of digits after “NDC”. The last group is the package size — two bottles of the same medicine can differ only in that group, and a recall may cover one but not the other.

Other recalled products from this labeler