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FDA (Drug enforcement)Recalled 2022-04-29closedclass iii

SUN PHARMACEUTICAL INDUSTRIES INC: buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottl

Is my product affected?

buPROPion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg packaged in a) 60-count bottle (47335-737-86), b)100-count bottle (47335-737-88), c)500-count bottle (47335-737-13), Rx only Distributed by: Sun Pharmaceutical Industries, Inc. Cranbury, NJ 08512, Manufactured by: Sun Pharmaceutical I

  • Brand BUPROPION HYDROCHLORIDE

Check against the official notice below — it lists the full affected range.

What happened

Sun Pharmaceutical Industries Inc. is recalling bupropion hydrochloride extended-release tablets (150 mg) distributed nationwide in the USA because customers found a dark, gritty substance in bottles that was identified as activated carbon from the desiccant canister inside the bottle. The recall affects 9,804 bottles across three package sizes: 60-count bottles (lot numbers JKX5126A, JKX5127A, JKX5128A), 100-count bottles (lot numbers JKX5126B, JKX5128B), and 500-count bottles (lot numbers JKX5126C, JKX5127C, JKX5128C), all with expiration dates of 10/2022.

The source document does not specify what affected consumers should do regarding this recall.

Written by software from the official notice below. Not reviewed by a lawyer.

Hazard

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.

Details from the source

Reason for recall: 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. Distribution: Nationwide in the USA Quantity: 9804 bottles Lot/code info: Lot #: a) JKX5126A, JKX5127A, JKX5128A, Exp 10/2022; b) JKX5126B , JKX5128B, Exp 10/2022; c)JKX5126C, JKX5127C, JKX5128C, Exp 10/2022;

Source

Official record: FDA (Drug enforcement) ↗

Republished from the official source above; details can change — the source record controls.

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