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Use caution Drug recall · FDA · Published November 3, 2021

Ascend Labs Recalls Cefixime Capsules Due to Impurity Issues

Ascend Laboratories LLC recalls specific lots of Cefixime Capsules 400 mg due to failed impurity specifications. Check your bottle's lot number.

🇺🇸 FDA recall #D-0229-2022DrugAscend Laboratories ›
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Recalling firmAscend Laboratories LLC339 Jefferson Rd Ste 101 · Parsippany, NJ 07054-3707
✎ GovInfoNow plain-language explainer

Ascend Laboratories LLC is recalling bottles of Cefixime Capsules 400 mg because they contain failed impurities or degradation products that do not meet specifications. The recall affects 4,104 bottles distributed nationwide. No remedy details are currently provided in the record. Read more at govinfonow.com/recall/35576-ascend-labs-recalls-cefixime-capsules-due-to-impurity-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/35576-ascend-labs-recalls-cefixime-capsules-due-to-impurity-issues · Updated October 10, 2026 · FDA enforcement record: FDA #D-0229-2022

Cite this page

“Ascend Labs Recalls Cefixime Capsules Due to Impurity Issues.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35576-ascend-labs-recalls-cefixime-capsules-due-to-impurity-issues. Based on FDA recall #D-0229-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0229-2022%22&limit=1).

The FDA announced on November 3, 2021, that Ascend Laboratories LLC voluntarily recalled Cefixime Capsules 400 mg due to failed impurities and degradation specifications. The recall affects 4,104 bottles distributed nationwide.

How to tell if you have it

  • Brand: Ascend Laboratories
  • Product: Cefixime Capsules 400 mg
  • NDC: 67877-584-50
  • Lot code: 20140282
  • Expiration date: December 2021
  • Quantity: 4,104 bottles

The hazard

The recall was issued because the Cefixime Capsules failed impurities and degradation specifications. The FDA classified this as a Class II recall.

Context

GovInfoNow's records show Ascend Laboratories, LLC has had 35 other recalls on record since November 2, 2016. Other recent recalls of similar products include Dabigatran Etexilate Capsules (July 16, 2026), Amlodipine/Olmesartan tablets (July 8, 2026), and Dabigatran etexilate capsules (June 30, 2026). Other recent recalls of similar products include Temozolomide 5mg Capsules (March 3, 2026), Fluocinolone Acetonide Solution (December 30, 2025), and Methohexital Sodium (June 24, 2026).

How to tell if you have this one

Check your bottle for NDC 67877-584-50 and Lot number 20140282 with an expiration date of December 2021. The product is manufactured by Alken Laboratories Ltd. in India and distributed by Ascend Laboratories LLC in Parsippany, NJ.

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

What to do — step by step

  1. Check Your Bottle

    Verify if your Cefixime Capsules match NDC 67877-584-50 and Lot 20140282 expiring in Dec 2021.

  2. Contact Your Pharmacist

    Speak with your pharmacist or healthcare provider to determine if you have the recalled product and what steps to take next.

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

Distributed nationwide.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Nov 3, 202112. FDA classified it Class II: Nov 9, 202123. Published in FDA’s Enforcement Report: Nov 17, 202134. FDA terminated the recall: Dec 21, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

How many bottles are being recalled?

A total of 4,104 bottles are included in this recall.

Where was the product distributed?

The product was distributed nationwide across the United States.

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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-0229-2022 (November 3, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0229-2022 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 10, 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