Skip to content
Lower risk Drug recall · FDA · Published July 11, 2023

Ascend Fingol: Capsules with Failed Dissolution Specifications Recalled

Ascend Laboratories recalls 0.5mg Fingolimod capsules (NDC 67877-476-30) due to failed dissolution specifications. This may affect drug effectiveness.

🇺🇸 FDA recall #D-0925-2023DrugAscend Laboratories ›
Take action

Contact the company

Recalling firmAscend Laboratories, LLC339 Jefferson Rd Ste 101 · Parsippany, NJ 07054-3707
✎ GovInfoNow plain-language explainer

Ascend Laboratories is recalling 0.5 mg Fingolimod capsules (30-count bottles) that failed dissolution tests. This could mean the medication doesn't work properly for patients needing it. Read more at govinfonow.com/recall/33376-ascend-fingol-capsules-with-failed-dissolution-specifications-recalled.

Source Summary by GovInfoNow · govinfonow.com/recall/33376-ascend-fingol-capsules-with-failed-dissolution-specifications-recalled · Updated August 17, 2026 · FDA enforcement record: FDA #D-0925-2023

Cite this page

“Ascend Fingol: Capsules with Failed Dissolution Specifications Recalled.” GovInfoNow, updated August 17, 2026. https://govinfonow.com/recall/33376-ascend-fingol-capsules-with-failed-dissolution-specifications-recalled. Based on FDA recall #D-0925-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0925-2023%22&limit=1).

The FDA announced on July 11, 2023, that Ascend Laboratories, LLC voluntarily recalled Fingolimod Capsules due to failed dissolution specifications. The recall affects 2,652 bottles distributed nationwide.

How to tell if you have it

  • Brand: Ascend Laboratories
  • Product: Fingolimod Capsules, 0.5 mg, 30-count bottle
  • NDC: 67877-476-30
  • Lot code: 22122841
  • Expiration date: August 2025
  • Manufacturer: Alkem Laboratories Ltd., INDIA
  • Distributor: Ascend Laboratories, LLC, Parsippany, NJ 07054

The hazard

The product failed dissolution specifications, according to the FDA. The recall is classified as Class II.

Context

GovInfoNow's records show Ascend Laboratories, LLC has 35 other recalls on record since November 2, 2016. Other recent recalls of similar products include Inventia Chlorthalidone Recall (September 3, 2026), Sun Pharmaceutical Lisdexamfetamine Capsules Recall (October 28, 2025), and AvKARE Amantadine Capsules Recall (February 13, 2026).

How to tell if you have this one

Check for the 0.5 mg Fingolimod capsules (30-count bottle) with NDC 67877-476-30. The lot number is 22122841, expiring August 2025.

  • Brand
    Ascend Laboratories
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Medication Details

    Verify the product label shows NDC 67877-476-30 and lot number 22122841.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 15 days after the firm started it.

1. Firm started the recall: Jul 11, 202312. FDA classified it Class II: Jul 18, 202323. Published in FDA’s Enforcement Report: Jul 26, 202332023
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Ascend Laboratories recalls

Latest drug recalls

Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-0925-2023 (July 11, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0925-2023 to see it in context.
  • Plain-language summary written by qwen3:4b on August 17, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA