Prescription drug recall: Fingolimod capsules fail dissolution specifications
Ascend Laboratories is recalling 2,652 bottles of Fingolimod capsules nationwide because they failed to meet dissolution specifications, potentially affecting medication effectiveness.
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: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—failed dissolution specifications—is precautionary in nature, affecting medication efficacy without documented adverse health consequences. Class II recalls address situations where the probability of serious adverse health consequences is remote.
Plain-English summary
Ascend Laboratories, LLC is recalling Fingolimod capsules, 0.5 mg strength, manufactured by Alkem Laboratories Ltd. of India. The recall affects approximately 2,652 bottles distributed nationwide in the United States, identified by NDC 67877-476-30, lot 22122841, expiring August 2025.
The reason for the recall is that the capsules failed to meet dissolution specifications. Dissolution specifications define the rate at which a medication releases from its capsule for absorption in the body. When these specifications are not met, the medication may not dissolve properly, potentially reducing its effectiveness.
Patients currently taking this medication should contact their pharmacy or healthcare provider to determine whether they have an affected batch. If you have questions about this recall, you may contact Ascend Laboratories or the FDA.
The recalled product
- Product
- FINGOLIMOD (FINGOLIMOD HYDROCHLORIDE)
- Brand
- FINGOLIMOD
- Manufacturer
- Ascend Laboratories, LLC
- Category
- Drug
- Affected units
- 2,652
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 22122841
- Exp August 2025
Distribution
Distributed nationwide across the United States.
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