Agency classClass IIIOur severity:Moderate FDA (Drugs)·D-0007-2017·Announced 2016-10-12

Sun Pharmaceutical Recalls Bupropion Hydrochloride Tablets for Dissolution Failures

Sun Pharmaceutical Industries is recalling 31,762 bottles of Bupropion Hydrochloride Extended-Release Tablets because they failed dissolution specifications.

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 the product is not likely to cause adverse health consequences. The hazard is a failure to meet dissolution specifications, which is a quality control issue rather than a direct safety threat like contamination or mislabeling.

Plain-English summary

Sun Pharmaceutical Industries, Inc. is recalling 31,762 bottles of Bupropion Hydrochloride Extended-Release Tablets, USP (SR), 150 mg, Twice-A-Day. The affected product is distributed in 60-count bottles and is available by prescription only. The recall is limited to specific lot codes JKN5124A and JKN5229A with an expiration date of 10/2016.

The recall was initiated because the tablets failed to meet dissolution specifications. Dissolution testing ensures that a drug releases its active ingredient at the appropriate rate and amount in the body. When these specifications are not met, the medication may not work as intended.

The affected product was distributed nationwide. Consumers who have this medication should check their bottles for the specific lot codes and expiration date listed above. If the product matches the recall details, patients should contact their healthcare provider or pharmacist for guidance on how to proceed.

The recalled product

Product: BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Brand: BUPROPION HYDROCHLORIDE
Manufacturer: Sun Pharmaceutical Industries, Inc.
Category: Drug — Prescription Medication
Hazard: dissolution-failure
Affected units: 31,762

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 (2)

JKN5124A and JKN5229A
exp 10/2016

UPCs (3)

0347335738865
0347335737868
347335737868

Distribution

Distributed nationwide across the United States.

Same brand · BUPROPION HYDROCHLORIDE

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