Clonazepam Tablets Recalled Due to Manufacturing Defect
Sun Pharmaceutical is recalling Clonazepam Orally Disintegrating Tablets (0.125mg) due to manufacturing defects where oversized tablets were found. The affected lot (MHC1430A, exp. 09/2023) was distributed nationwide.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: This is an FDA Class II recall of a prescription medication with a demonstrated manufacturing defect (oversized tablets found) affecting tablet specifications. No illnesses or injuries have been reported, but the defect presents a risk of dosing inconsistency in a controlled-substance medication. This meets the rubric criterion of risk-of-harm products where injury has not yet been reported.
Plain-English summary
Sun Pharmaceutical Industries Inc is recalling Clonazepam Orally Disintegrating Tablets, USP, 0.125mg (NDC 57664-783-68) distributed in bottles of 60 tablets. The recall affects lot MHC1430A with expiration date 09/2023, totaling approximately 4,608 bottles.
The tablets were found to not meet tablet/capsule specifications during quality control. Oversized tablets were discovered in bottles, indicating a manufacturing defect that could affect product consistency and dosing.
This product was distributed nationwide within the United States. Patients taking this medication should verify their lot number (MHC1430A) against their prescription bottle. Those with the affected lot should contact their healthcare provider or pharmacist for guidance.
The recalled product
- Product
- Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, Mfd. by: Sun Pharmaceutical Industries Ltd. Mumbai, India, Dist. by: Sun Pharmaceutical Industries In., Cranbury, NJ 08512, NDC 57664-783-68, packaged in bottles.
- Manufacturer
- SUN PHARMACEUTICAL INDUSTRIES INC
- Category
- Drug — Benzodiazepine
- Affected units
- 4,608
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 #: MHC1430A
- Exp. Date 09/2023
Distribution
Distributed nationwide across the United States.
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