The Recall Desk
Agency classClass IIIOur severity:ModerateFDA (Drugs)·D-0858-2022·Announced 2022-05-18

Bupropion Extended-Release Tablets Recalled for Activated Carbon Contamination

Sun Pharmaceutical is recalling Bupropion Extended-Release 200mg tablets after customers found activated carbon particles inside bottles from the desiccant canister.

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: FDA Class III recall involving low-risk contamination (activated carbon from desiccant canister). No illnesses or injuries reported; the hazard is theoretical rather than confirmed.

Plain-English summary

Sun Pharmaceutical Industries Inc is recalling Bupropion Hydrochloride Extended-Release 200mg tablets, USP. The recall was initiated after customers reported finding dark, gritty particles inside medication bottles. The particles were identified as activated carbon that originated from the desiccant canister inside the packaging.

The recalled product is distributed nationwide in the United States and consists of 60-count bottles. The affected lot is HAC2237A with an expiration date of May 2023.

Consumers who have obtained this medication are advised to check their bottle's lot number and expiration date to determine if their product is affected by this recall.

The recalled product

Product
BUPROPION HYDROCHLORIDE (BUPROPION HYDROCHLORIDE)
Brand
BUPROPION HYDROCHLORIDE
Manufacturer
SUN PHARMACEUTICAL INDUSTRIES INC
Category
Drug
Hazard
Affected units
744

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)

  • Lot #: HAC2237A
  • exp. date 05/2023

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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