Medications & Supplements/Prescription Drugs

Fingolimod Capsules Recalled for Failed Dissolution Specifications

Agency Publication Date: July 18, 2023

Summary

Ascend Laboratories, LLC is recalling 2,652 bottles of Fingolimod Capsules (0.5 mg), a prescription medication used to treat relapsing forms of multiple sclerosis. The recall was issued because the capsules failed dissolution testing, which means the drug may not dissolve properly once swallowed. If the medication does not dissolve as intended, the patient may not receive the full dose required to manage their condition.

Risk

When a drug fails to dissolve correctly, it can lead to decreased effectiveness of the treatment. For patients with multiple sclerosis, this could result in an inadequate therapeutic response and a potential return or worsening of symptoms.

What You Should Do

The recalled product is Fingolimod Capsules, 0.5 mg, distributed in 30-count bottles by Ascend Laboratories, LLC (NDC 67877-476-30).
Check your medication bottle for lot number 22122841 with an expiration date of August 2025 to determine if your prescription is affected.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fingolimod Capsules (0.5 mg)

Variants: 0.5 mg, 30-count bottle, Rx Only

Lot Numbers:

22122841 (Exp August 2025)

NDC:

67877-476-30

Manufactured by Alkem Laboratories Ltd., INDIA; Distributed by Ascend Laboratories, LLC, Parsippany, NJ 07054.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 92667

Status: Active

Manufacturer: Ascend Laboratories, LLC

Sold By: Pharmacies

Manufactured In: India

Units Affected: 2652 bottles

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

What You Should Do

The recalled product is Fingolimod Capsules, 0.5 mg, distributed in 30-count bottles by Ascend Laboratories, LLC (NDC 67877-476-30).

Check your medication bottle for lot number 22122841 with an expiration date of August 2025 to determine if your prescription is affected.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.