Medications & Supplements/Prescription Drugs

Ascend Laboratories LLC: Cephalexin for Oral Suspension Recalled for Unidentified Impurities

Agency Publication Date: February 18, 2021

Summary

Ascend Laboratories LLC is recalling approximately 37,641 bottles of Cephalexin for Oral Suspension (an antibiotic) because testing found unidentified impurities at levels higher than the allowed specification. This recall affects the 250 mg per 5 mL strength in both 100 mL and 200 mL bottle sizes. Consumers should check their medicine cabinets for the specific lot numbers and expiration dates affected by this voluntary action.

Risk

The presence of unidentified impurities at levels exceeding safety specifications could potentially lead to unexpected side effects or reduced effectiveness of the antibiotic treatment. While no specific injuries have been reported, the manufacturing deviation means the product does not meet strict quality standards.

What You Should Do

Check your medication label to see if you have Cephalexin for Oral Suspension, USP 250 mg per 5 mL, distributed by Ascend Laboratories LLC with NDC numbers 67877-545-88 or 67877-545-68.
For 100 mL bottles (NDC 67877-545-88), look for lot number 19144841 (Exp 9/2021) or 20141673 (Exp 4/2022).
For 200 mL bottles (NDC 67877-545-68), look for lot numbers 19141869 or 19141870 (Exp 3/2021), 19142762 (Exp 5/2021), or 19143826, 19143923, 19143941, 19143954 (Exp 7/2021).
Contact your healthcare provider or pharmacist immediately for guidance on whether to continue use or for help obtaining a replacement prescription.
Return any unused portion of the affected medication to your pharmacy for a refund.
Contact Ascend Laboratories LLC at their Parsippany, New Jersey office for further instructions regarding this recall.
For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Pharmacy refund and healthcare 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

Recall #: D-0263-2021

Lot Numbers:

19144841 (Exp 9/2021)

20141673 (Exp 4/2022)

Date Ranges: September 2021, April 2022

Product: Cephalexin for Oral Suspension, USP 250 mg per 5 mL (200 mL)

Model:

NDC 67877-545-68

Recall #: D-0264-2021

Lot Numbers:

19141869 (Exp 3/2021)

19141870 (Exp 3/2021)

19142762 (Exp 5/2021)

19143826 (Exp 7/2021)

19143923 (Exp 7/2021)

19143941 (Exp 7/2021)

19143954 (Exp 7/2021)

Date Ranges: March 2021, May 2021, July 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 87214

Status: Resolved

Manufacturer: Ascend Laboratories LLC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 2 products (14,205 100 mL bottles; 23,436 200 mL 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 · 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.

Summary

Risk

What You Should Do

Check your medication label to see if you have Cephalexin for Oral Suspension, USP 250 mg per 5 mL, distributed by Ascend Laboratories LLC with NDC numbers 67877-545-88 or 67877-545-68.

For 100 mL bottles (NDC 67877-545-88), look for lot number 19144841 (Exp 9/2021) or 20141673 (Exp 4/2022).

For 200 mL bottles (NDC 67877-545-68), look for lot numbers 19141869 or 19141870 (Exp 3/2021), 19142762 (Exp 5/2021), or 19143826, 19143923, 19143941, 19143954 (Exp 7/2021).

Contact your healthcare provider or pharmacist immediately for guidance on whether to continue use or for help obtaining a replacement prescription.

Return any unused portion of the affected medication to your pharmacy for a refund.

Contact Ascend Laboratories LLC at their Parsippany, New Jersey office for further instructions regarding this recall.

For additional questions, call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Cephalexin for Oral Suspension, USP 250 mg per 5 mL (100 mL)

Model:

NDC 67877-545-88

Recall #: D-0263-2021

Lot Numbers:

19144841 (Exp 9/2021)

20141673 (Exp 4/2022)

Date Ranges: September 2021, April 2022

Product: Cephalexin for Oral Suspension, USP 250 mg per 5 mL (200 mL)

Model:

NDC 67877-545-68

Recall #: D-0264-2021

Lot Numbers:

19141869 (Exp 3/2021)

19141870 (Exp 3/2021)

19142762 (Exp 5/2021)

19143826 (Exp 7/2021)

19143923 (Exp 7/2021)

19143941 (Exp 7/2021)

19143954 (Exp 7/2021)

Date Ranges: March 2021, May 2021, July 2021