UnratedDrug recall · FDA · Published November 23, 2020
Ascend Laboratories recalls Cephalexin oral suspension with impurities
Ascend Laboratories recalls Cephalexin oral suspension (125mg/5mL) due to unidentified impurities in some lots. Products may not meet safety standards.
Failed Impurity/Degradation Specifications: Unidentified impurities not complying with specifications were observed in various lots of Cephalexin FOS USP 125 mg/5 mL.
“Ascend Laboratories recalls Cephalexin oral suspension with impurities.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36658-ascend-laboratories-recalls-cephalexin-oral-suspension-with-impurities. Based on FDA recall #D-0185-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0185-2021%22&limit=1).
The FDA announced on November 23, 2020, that Ascend Laboratories LLC voluntarily recalled Cephalexin for Oral Suspension due to failed impurity specifications. The recall affects 20,232 bottles distributed nationwide in the USA.
How to tell if you have it
Brand: Ascend Laboratories
Product: Cephalexin for Oral Suspension, USP, 125 mg per 5 mL
NDC 67877-544-88 (100 ml bottle), Lot#s 19144340, 19144341, Exp AUG 2021
NDC 67877-544-68 (200 ml bottle), Lot#s 20142226, 20142227, Exp MAY 2022
The hazard
Unidentified impurities not complying with specifications were observed in various lots of the drug. 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 Dabigatran Etexilate Capsules (July 16, 2026), Amlodipine/Olmesartan tablets (July 8, 2026), and Dabigatran etexilate capsules (June 30, 2026).
How to tell if you have this one
Check for the product name 'Cephalexin for Oral Suspension, USP, 125 mg per 5 mL'. Look for the NDC numbers 67877-544-88 (100ml bottle) or 67877-544-68 (200ml bottle).
Brand
Ascend Laboratories
Category
Drug
Based on the official FDA remedy
What to do — step by step
Check Product Details
Identify the NDC numbers 67877-544-88 or 67877-544-68 on the product label.
Where it went and when
Where it was distributed
Distributed nationwide.
Nationwide
Not listed
FDA distribution: “Distributed 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 terminated this recall 2.5 years after the firm started it.
1Firm started the recall
2FDA classified it Class II
3Published in FDA’s Enforcement Report
4FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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-0185-2021 (November 23, 2020) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0185-2021 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.