Use caution Drug recall · FDA · Published December 21, 2021

Ascend Labs Recalls Cefixime Capsules Due to Impurities

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

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0359-2022Drug Ascend Laboratories ›

Use caution until it’s fixed

Failed impurities/degradation specifications

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Contact the company

Recalling firmAscend Laboratories, LLC339 Jefferson Rd Ste 101 · Parsippany, NJ 07054-3707

✎ GovInfoNow plain-language explainer

Ascend Laboratories, LLC has recalled Cefixime Capsules, 400 mg, in 50-count bottles because the product failed impurity and degradation specifications. The recall affects 42,698 bottles distributed nationwide in the USA. Consumers should check their medication against the specific lot numbers listed in the record. Read more at govinfonow.com/recall/35418-ascend-labs-recalls-cefixime-capsules-due-to-impurities.

Source Summary by GovInfoNow · govinfonow.com/recall/35418-ascend-labs-recalls-cefixime-capsules-due-to-impurities · Updated October 10, 2026 · FDA enforcement record: FDA #D-0359-2022

Cite this page

“Ascend Labs Recalls Cefixime Capsules Due to Impurities.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/35418-ascend-labs-recalls-cefixime-capsules-due-to-impurities. Based on FDA recall #D-0359-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0359-2022%22&limit=1).

Ascend Laboratories, LLC voluntarily recalled Cefixime Capsules, 400 mg, distributed nationwide, after the FDA announced the recall on Dec. 21, 2021, due to failed impurities and degradation specifications. The Food and Drug Administration said the Class II recall affects approximately 42,698 bottles.

How to tell if you have it

Brand: Ascend Laboratories
Product: Cefixime Capsules 400 mg
Packaging: 50-count bottles
NDC: 67877-584-50
Lot codes: 20140293, 20141525, 20141526, 20141527, 20143019, 20143020, 20143021, 20143022, 20144759, 20144760, 20144761
Expiration dates: Dec 2021, Mar 2022, July 2022, Nov 22
Quantity: 42,698 bottles

The hazard

The FDA said the Cefixime Capsules failed impurities and degradation specifications. The recall was classified as Class II.

Context

GovInfoNow's records show Ascend Laboratories, LLC has had 35 other recalls on record since Nov. 2, 2016. Other recent recalls of similar products include Rising Pharma recalling Temozolomide 5mg Capsules due to impurity issues (March 3, 2026), Sun Pharmaceutical's Fluocinolone Acetonide Solution recall for impurity risk (Dec. 30, 2025), and QuVa Pharma recalling Methohexital Sodium due to impurity failures (June 24, 2026).

How to tell if you have this one

Look for Cefixime Capsules, 400 mg, in 50-count bottles distributed by Ascend Laboratories, LLC (Parsippany, NJ). Check the NDC 67877-584-50 and verify if your bottle has one of these lot numbers: 20140293 (Exp Dec 2021), 20141525 (Exp Mar 2022), 20143019, 20143020, 20143021, 20143022 (Exp July 2022), or 20144759, 20144760, 20144761 (Exp Nov 2022).

Brand
Ascend Laboratories
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Bottle
Compare the lot number and expiration date on your Cefixime Capsules bottle against the recalled lots listed in the record.
Contact Your Pharmacist
If you have a recalled lot, contact your pharmacy or healthcare provider for instructions on replacement or disposal.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA 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 16 months after the firm started it.

Dec 21, 2021Firm started the recall
Jan 5, 2022FDA classified it Class II
Jan 12, 2022Published in FDA’s Enforcement Report
Apr 13, 2023FDA terminated the recall

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

Similar recalls

Other Ascend Laboratories recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/35418-ascend-labs-recalls-cefixime-capsules-due-to-impurities">Ascend Labs Recalls Cefixime Capsules Due to Impurities (GovInfoNow)</a>

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-0359-2022 (December 21, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0359-2022 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.