The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0857-2022·Announced 2022-05-18

Bupropion Hydrochloride 150 mg Extended-Release Tablets Recalled for Activated Carbon Contamination

Sun Pharmaceutical is recalling Bupropion Hydrochloride 150 mg extended-release tablets distributed nationwide due to activated carbon particles from desiccant canisters found in bottles. No illnesses have been reported.

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: This is an FDA Class III recall with no reported illnesses or injuries. The hazard is a manufacturing defect—activated carbon particles from desiccant material—rather than a safety-critical contamination. Per the rubric, Class III recalls are typically scored 1 or 2; the presence of foreign substance justifies a score of 2 (Moderate) rather than 1 (Low).

Plain-English summary

Sun Pharmaceutical Industries Inc. is recalling Bupropion Hydrochloride Extended-Release Tablet, USP (SR), 150 mg due to the presence of activated carbon particles that escaped from desiccant canisters inside bottles. Approximately 9,804 bottles were affected and distributed nationwide.

Affected lot numbers are JKX5126A, JKX5127A, JKX5128A, JKX5126B, JKX5128B, JKX5126C, JKX5127C, and JKX5128C, all with expiration date 10/2022. The medication was distributed in 60-count, 100-count, and 500-count bottles. No illnesses or injuries related to this contamination have been reported. Patients who believe they have an affected bottle should contact their pharmacy or physician.

The recalled product

Product
BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Brand
BUPROPION HYDROCHLORIDE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug
Hazard
Affected units
9,804

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 (9)

  • Lot #: a) JKX5126A
  • JKX5127A
  • JKX5128A
  • Exp 10/2022
  • b) JKX5126B
  • JKX5128B
  • c)JKX5126C
  • JKX5127C
  • JKX5128C

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 →

Related recalls

Same brand · BUPROPION HYDROCHLORIDE

Same manufacturer · SUN PHARMACEUTICAL INDUSTRIES INC

See all →

Same hazard · foreign substance

See all →

Similar recalls