The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0445-2017·Announced 2017-02-01

Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

Sun Pharmaceutical Industries is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets because they failed dissolution specifications and a 18-month stability time point.

The agency’s classification

FDA (Drugs): Class III

Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class III, which indicates a low risk of adverse health consequences. The failure of dissolution specifications and stability time points represents a quality control issue that may affect drug efficacy but is not associated with immediate serious harm.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling specific lots of Bupropion Hydrochloride Extended-release Tablets, USP (SR), 150 mg. The affected products are available in 60-count, 100-count, and 500-count bottles and are distributed nationwide. The recall was initiated because the tablets failed to meet dissolution specifications and a 18-month stability time point.

The recall covers specific lot numbers and expiration dates ranging from January 2017 to October 2017. The products are prescription-only medications manufactured by Sun Pharmaceutical Ind. Ltd. in India and distributed by Sun Pharmaceutical Industries, Inc. in Cranbury, New Jersey.

Consumers and healthcare providers should check their inventory for the specific lot numbers and expiration dates listed in the official recall notice. If the product matches the recalled lots, it should be returned to the pharmacy or supplier for credit or replacement.

The recalled product

Product
BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Brand
BUPROPION HYDROCHLORIDE
Manufacturer
Sun Pharmaceutical Industries, Inc.
Category
Drug — Prescription Medication
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • a) 60 count JKP1184A
  • exp 2/17
  • JKP1576A
  • JKP2517A
  • JKP2527A
  • exp 04/17
  • JKP2768A exp 06/17
  • KP3895A
  • JKP4051A
  • exp 08/17
  • JKP4052A
  • JKP4605A exp 09/17 b) 100 count JKP0702A exp 01/17
  • JKP1186A exp 02/17
  • JKP2766A
  • exp 05/17
  • JKP3368A
  • JKP3369A exp 06/17
  • JKP3419A
  • JKP3420A exp 07/17
  • JKP4056A

UPCs (2)

  • 0347335738865
  • 0347335737868

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 2 recalled by Sun Pharmaceutical Industries, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 2 products in this recall →

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