The Recall Desk
ModerateFDA (Drugs)·D-0462-2023·Announced 2023-03-22

Clobazam tablets recalled for potential manufacturing cross-contamination risk

Breckenridge Pharmaceuticals is recalling certain lots of Clobazam 10 mg tablets due to a potential cross-contamination risk stemming from manufacturing process deviations.

What this means for you

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 II recall with theoretical hazard (potential contamination) and no reported illnesses or injuries. This is a precautionary, manufacturing-practice-based recall fitting the criterion for low-risk contamination.

Plain-English summary

Breckenridge Pharmaceuticals, Inc. is recalling specific lots of Clobazam Tablets 10 mg manufactured by Centaur Pharmaceuticals Pvt. Ltd. (Pune, India) and distributed throughout the United States.

The recall was issued because the manufacturing facilities deviated from Current Good Manufacturing Practice (CGMP) standards, creating a potential risk of cross-contamination during production.

The affected lots are: Lot #5210085 (expires 12/2023), Lot #5210248 (expires 01/2024), and Lot #5220796 (expires 07/2025). Patients taking Clobazam should not stop their medication without consulting their healthcare provider. Contact your pharmacy or healthcare provider for guidance; they can verify if your medication is from a recalled lot.

The recalled product

Product
Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA, Distributed by: Breckenridge Pharmaceuticals, Inc., Berlin, CT 06037, NDC 51991-900-01
Manufacturer
Breckenridge Pharmaceutical, Inc
Category
Drug
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 (6)

  • Lot # 5210085
  • Exp 12/2023
  • 5210248
  • Exp 01/2024
  • 5220796
  • Exp 07/2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 6 recalled by Breckenridge Pharmaceutical, 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 6 products in this recall →

Related recalls

Same manufacturer · Breckenridge Pharmaceutical, Inc

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Same hazard · cross contamination

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