Caraco Recalls Oxcarbazepine Tablets Due to Broken Tablets
Caraco Pharmaceutical Laboratories is recalling 7,005 bottles of Oxcarbazepine 300 mg tablets because some tablets are broken.
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: The recall is classified as FDA Class II, and the hazard involves broken tablets, which is a physical defect rather than a high-risk chemical contamination or mislabeling of a common allergen.
Plain-English summary
Caraco Pharmaceutical Laboratories Ltd. is recalling 7,005 bottles of Oxcarbazepine Tablets, 300 mg, 100 tablet bottles. The recall is due to the presence of broken tablets in the product.
The affected product is identified by Lot # JKM7075A and has an expiration date of 10/15. The medication is distributed nationwide. The tablets are manufactured by Sun Pharmaceutical Ind. Ltd. in India and distributed by Caraco in Detroit, Michigan.
Consumers should check their medication for the specific lot number and expiration date. If the product matches the recalled lot, they should stop using it and contact their pharmacist or healthcare provider for guidance.
The recalled product
- Product
- OXCARBAZEPINE (OXCARBAZEPINE)
- Brand
- OXCARBAZEPINE
- Manufacturer
- Caraco Pharmaceutical Laboratories Ltd.
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 7,005
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 #: JKM7075A
- Expiry:10/15
UPCs (3)
- 0362756183834
- 0362756185838
- 0362756184831
Distribution
Distributed nationwide across the United States.
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