Lacosamide Oral Solution recalled for defective leaking containers
Apotex Corp. is recalling Lacosamide Oral Solution because certain bottles may leak when stored horizontally. Patients taking this seizure medication should contact their pharmacy or healthcare provider.
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 classified this as Class II, and the hazard is a defective container with potential for medication leakage. The source text does not report any illnesses or injuries, making this a precautionary recall due to a manufacturing defect.
Plain-English summary
Apotex Corp. is recalling Lacosamide Oral Solution, USP, 10 mg/mL in 200 mL bottles (NDC 60505-0405-4) distributed nationwide in the United States. The recall was initiated due to defective containers that may leak when stored horizontally.
Lacosamide is a prescription medication used to treat seizures. A leaking container could result in loss of medication and potential patient harm if the patient does not receive the intended dose.
Patients currently taking this medication should not stop taking it without consulting their healthcare provider. Instead, contact the pharmacy where the prescription was filled or speak with a healthcare provider about obtaining a replacement supply. The affected batch is Batch # TZ5589 with expiration date 01/31/2026. Approximately 20,648 bottles were distributed.
The recalled product
- Product
- Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Apotex Inc., Toronto, Ontario, Canada M9L 1T9, Manufactured for: Apotex Corp., Weston FL 33326, NDC 60505-0405-4
- Manufacturer
- Apotex Corp.
- Affected units
- 20,648
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)
- Batch # TZ5589
- Exp Date: 01/31/2026
Distribution
Distributed nationwide across the United States.
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