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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Cephalexin for Oral Suspension Recalled for Failed Impurity Specifications

Agency Publication Date: December 30, 2020
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Summary

Ascend Laboratories LLC is recalling 38,841 bottles of Cephalexin for Oral Suspension (250 mg per 5 mL), a prescription antibiotic used to treat bacterial infections. The recall includes both 100 mL and 200 mL bottle sizes because the medication failed to meet impurity and degradation specifications during testing. This defect means the drug may not have the expected potency or could contain unintended chemical breakdown products, which could impact the effectiveness of the treatment.

Risk

The failure to meet impurity and degradation specifications may result in reduced drug efficacy or exposure to degradation products. This could lead to a less effective treatment for bacterial infections, potentially allowing the infection to persist or worsen.

What You Should Do

  1. Identify if you have the affected 100 mL bottles (NDC 67877-545-88) by checking for lot numbers 20141674, 20141675, 20141676, 20141677, or 20141678.
  2. Identify if you have the affected 200 mL bottles (NDC 67877-545-68) by checking for lot numbers 20141680, 20141681, or 20141759.
  3. Contact your healthcare provider or pharmacist immediately to discuss whether you should continue using the medication or if a replacement prescription is necessary.
  4. Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.
  5. Contact Ascend Laboratories LLC at their Parsippany, NJ office or through your dispensing pharmacy for further instructions regarding the return process.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Drug recall refund and consultation

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Cephalexin for Oral Suspension, USP 250 mg per 5 mL (100 ml)
Model:
NDC 67877-545-88
Lot Numbers:
20141674
20141675
20141676
20141677
20141678
Product: Cephalexin for Oral Suspension, USP 250 mg per 5 mL (200 ml)
Model:
NDC 67877-545-68
Lot Numbers:
20141680
20141681
20141759

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 87032
Status: Resolved
Manufacturer: Ascend Laboratories LLC
Sold By: pharmacies nationwide
Manufactured In: India, United States
Units Affected: 2 products (29,317 bottles; 9,524 bottles)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.