Ascend Laboratories recalls Cephalexin oral suspension due to impurities
Ascend Laboratories recalls Cephalexin oral suspension (250mg/5mL) with unidentified impurities above safety limits. This prescription medication was manufactured in India and distributed in the US. Consumers should not use the recalled product.
Recall notice
CGMP Deviations: Individual Unidentified impurities results of the product was found at higher side of the specification limit.
Contact the company
What happened, in plain English
Ascend Laboratories has recalled a specific prescription Cephalexin oral suspension product due to impurities found in the medication. This recall affects patients who have been prescribed this medication and may pose a risk to their health if the impurities exceed safe levels. Read more at govinfonow.com/recall/36545-ascend-laboratories-recalls-cephalexin-oral-suspension-due-to-impurities.
Source Summary by GovInfoNow · govinfonow.com/recall/36545-ascend-laboratories-recalls-cephalexin-oral-suspension-due-to-impurities · Updated October 4, 2026 · FDA enforcement record: FDA #D-0263-2021
Cite this page
“Ascend Laboratories recalls Cephalexin oral suspension due to impurities.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36545-ascend-laboratories-recalls-cephalexin-oral-suspension-due-to-impurities. Based on FDA recall #D-0263-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0263-2021%22&limit=1).
Why it’s dangerous
The product contains unidentified impurities that exceed the acceptable safety limits. This could potentially cause health issues for patients using the medication, though the exact risk level is not specified in the recall notice.
Who’s affected
Prescription patients who have been prescribed this specific Cephalexin oral suspension (250mg/5mL) and received it from the manufacturer in India. Patients with the medication's lot number 19144841 or expiration date 9/2021 are most at risk.
How to tell if you have this one
Check for the product name 'Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx Only'. Look for the lot number 19144841 or expiration date 9/2021 on the packaging.
- Brand
Ascend Laboratories- Category
Drug
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 in the USA- NDC
67877-544-88, 67877-544-68, 67877-545-88, 67877-545-68
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0263-2021 | 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; Lot # 19144841, Exp 9/2021; 20141673 Exp 4/2022. | 14,205 100 mL bottles |
| D-0264-2021 | 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; Lot #: 19141869, 19141870, EXP 3/2021; 19142762, EXP 5/2021; 19143826, 19143923,19143941, 19143954 EXP 7/2021 | 23,436 200 mL bottles |
What to do — step by step
Stop using the product
If you have the recalled Cephalexin oral suspension with lot number 19144841 or expiration date 9/2021, stop using it immediately.
Where it went and when
Where it was distributed
Distributed nationwide.
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 terminated this recall 22 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
What should I do if I have the recalled product?
Stop using the product immediately and contact your healthcare provider for alternative treatment options.
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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-0263-2021 (January 22, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0263-2021 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.