Unrated Drug recall · FDA · Published December 17, 2020

Ascend Laboratories Cephalexin Suspension Recall: Impurity Risk

Ascend Laboratories recalls 250mg/5mL cephalexin oral suspension (NDC 67877-545-68) due to failed impurity specifications. Rx-only product manufactured in India, distributed in US. No remedy stated in official notice.

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

🇺🇸 FDA recall #D-0179-2021Drug Ascend Laboratories ›

Recall notice

Failed Impurity/Degradation Specifications

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 a prescription cephalexin oral suspension that may contain impurities. This could affect the safety and effectiveness of the medication if used as intended. Read more at govinfonow.com/recall/36592-ascend-laboratories-cephalexin-suspension-recall-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/36592-ascend-laboratories-cephalexin-suspension-recall-impurity-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0179-2021

Cite this page

“Ascend Laboratories Cephalexin Suspension Recall: Impurity Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36592-ascend-laboratories-cephalexin-suspension-recall-impurity-risk. Based on FDA recall #D-0179-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0179-2021%22&limit=1).

The FDA announced on 2020-12-17 that Ascend Laboratories LLC voluntarily recalled Cephalexin for Oral Suspension due to failed impurity and degradation specifications. The recall involves 9,524 bottles distributed nationwide.

How to tell if you have it

Brand: Ascend Laboratories
Product: Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed)
NDC: 67877-545-68
Lot codes: 20141680, 20141681, 20141759

The hazard

The product failed impurity and degradation specifications. The recall is classified as Class II.

Context

GovInfoNow's records show Ascend Laboratories, LLC has 35 other recalls on record since 2016-11-02. Other recent recalls of similar products include Dabigatran Etexilate Capsules (2026-07-16), Amlodipine/Olmesartan tablets (2026-07-08), and Dabigatran etexilate capsules (2026-06-30).

How to tell if you have this one

Check for the NDC numbers 67877-545-68, 20141680, or 20141759 on the label. The product is a prescription-only oral suspension manufactured in India and distributed by Ascend Laboratories in the US.

Brand
Ascend Laboratories
Category
Drug

FDA recall event · 2 products

All 2 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Terminated
Distribution
Nationwide
NDC
67877-544-88, 67877-544-68, 67877-545-88, 67877-545-68

Recall number	Product, codes & lots	Quantity
D-0178-2021	Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 100 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-88; 20141674, 20141675, 20141676, 20141677, 20141678,	29,317 bottles
D-0179-2021	Ascend Laboratories, llc Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx Only Manufactured by: Alkem Laboratories, Ltd, Mumbai -400 013 INDIA Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054 NDC 67877-545-68; 20141680, 20141681, 20141759	9,524 bottles

Based on the official FDA remedy

What to do — step by step

Check Product Label
Look for NDC numbers 67877-545-68, 20141680, or 20141759 on the label.

Where it went and when

Where it was distributed

Distributed nationwide.

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 2.4 years after the firm started it.

Dec 17, 2020Firm started the recall
Dec 30, 2020FDA classified it Class II
Jan 6, 2021Published in FDA’s Enforcement Report
May 3, 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/36592-ascend-laboratories-cephalexin-suspension-recall-impurity-risk">Ascend Laboratories Cephalexin Suspension Recall: Impurity Risk (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-0179-2021 (December 17, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0179-2021 to see it in context.
Plain-language summary written by qwen3:4b on October 4, 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.