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.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
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 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
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.
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