Medications & Supplements/Prescription Drugs

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

Agency Publication Date: January 4, 2021

Summary

Ascend Laboratories LLC is recalling 20,232 bottles of Cephalexin for Oral Suspension (125 mg per 5 mL), an antibiotic used to treat bacterial infections. This recall was initiated because routine testing discovered unidentified impurities and degradation that do not meet safety specifications. Consumers who have these specific bottles should stop using them and contact their healthcare provider or pharmacist, as the presence of unknown impurities may affect the medication's safety or effectiveness.

Risk

The presence of unidentified impurities means the medication has degraded or contains substances not intended to be in the product, which could lead to reduced treatment efficacy or unexpected side effects.

What You Should Do

Check your medicine cabinet for Cephalexin for Oral Suspension, USP, 125 mg per 5 mL in 100 ml or 200 ml bottles.
Identify if your bottle is part of the recall by checking the NDC and Lot numbers: for 100 ml bottles, look for NDC 67877-544-88 with lot numbers 19144340 or 19144341 (Exp AUG 2021); for 200 ml bottles, look for NDC 67877-544-68 with lot numbers 20142226 or 20142227 (Exp MAY 2022).
If your medication matches the affected lot numbers, contact your healthcare provider or pharmacist immediately for guidance on a replacement prescription.
Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.
Contact Ascend Laboratories LLC at their Parsippany, NJ office if you have additional questions regarding this recall.
For further consumer safety questions, contact 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

Healthcare consultation and pharmacy refund

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 (125 mg per 5 mL, 100 ml bottle)

Model:

NDC 67877-544-88

Lot Numbers:

19144340 (Exp AUG 2021)

19144341 (Exp AUG 2021)

Date Ranges: Expiration August 2021

Product: Cephalexin for Oral Suspension, USP (125 mg per 5 mL, 200 ml bottle)

Model:

NDC 67877-544-68

Lot Numbers:

20142226 (Exp MAY 2022)

20142227 (Exp MAY 2022)

Date Ranges: Expiration May 2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86850

Status: Resolved

Manufacturer: Ascend Laboratories LLC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 20,232 bottles

Distributed To: Nationwide

Agency Last Updated: January 5, 2021

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

What You Should Do

Check your medicine cabinet for Cephalexin for Oral Suspension, USP, 125 mg per 5 mL in 100 ml or 200 ml bottles.

Identify if your bottle is part of the recall by checking the NDC and Lot numbers: for 100 ml bottles, look for NDC 67877-544-88 with lot numbers 19144340 or 19144341 (Exp AUG 2021); for 200 ml bottles, look for NDC 67877-544-68 with lot numbers 20142226 or 20142227 (Exp MAY 2022).

If your medication matches the affected lot numbers, contact your healthcare provider or pharmacist immediately for guidance on a replacement prescription.

Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund.

Contact Ascend Laboratories LLC at their Parsippany, NJ office if you have additional questions regarding this recall.

For further consumer safety questions, contact 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 (125 mg per 5 mL, 100 ml bottle)

Model:

NDC 67877-544-88

Lot Numbers:

19144340 (Exp AUG 2021)

19144341 (Exp AUG 2021)

Date Ranges: Expiration August 2021

Product: Cephalexin for Oral Suspension, USP (125 mg per 5 mL, 200 ml bottle)

Model:

NDC 67877-544-68

Lot Numbers:

20142226 (Exp MAY 2022)

20142227 (Exp MAY 2022)

Date Ranges: Expiration May 2022