Medications & Supplements/Prescription Drugs

Ascend Cephalexin Oral Suspension Recalled for Failed Impurity Testing

Agency Publication Date: June 12, 2025

Summary

Ascend Laboratories, LLC is recalling 59,556 bottles of Cephalexin for Oral Suspension, USP (125 mg per 5 mL) due to the presence of an impurity found during stability testing. The recall affects 48,936 bottles of the 100 mL size and 10,620 bottles of the 200 mL size after a substance identified as Cephalexin Glucose Adduct was detected above approved specifications. Cephalexin is a prescription antibiotic used to treat various bacterial infections.

Risk

The presence of degradation impurities above approved limits can potentially reduce the effectiveness of the antibiotic or lead to unexpected side effects, although no specific adverse events have been reported for this recall.

What You Should Do

This recall affects Cephalexin for Oral Suspension, USP (125 mg per 5 mL) sold in 100 mL and 200 mL bottles under the Ascend Laboratories brand.
Check the medication bottle label for NDC codes 67877-544-88 (100 mL bottle) or 67877-544-68 (200 mL bottle). If the NDC matches, check the lot number and expiration date printed on the container.
See the Affected Products section below for the full list of affected codes.
If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cephalexin for Oral Suspension, USP, 125 mg per 5 mL (100 mL)by Ascend Laboratories, LLC

Variants: 125 mg per 5 mL, 100 mL (when mixed)

Lot Numbers:

23141828 (Exp 5/31/2025)

23141829 (Exp 5/31/2025)

23142342 (Exp 6/30/2025)

23142708 (Exp 7/31/2025)

23144035 (Exp 10/31/2025)

23144270 (Exp 11/302025)

24140026 (Exp 12/31/2025)

NDC:

67877-544-88

Manufactured by Alkem Laboratories Ltd., India; Distributed by Ascend Laboratories, LLC.

Product: Cephalexin for Oral Suspension, USP, 125 mg per 5 mL (200 mL)by Ascend Laboratories, LLC

Variants: 125 mg per 5 mL, 200 mL (when mixed)

Lot Numbers:

23142343 (Exp 6/30/2025)

23143526 (Exp 9/30/2025)

23144036 (Exp 10/31/2025)

23144269 (Exp 11/30/2025)

24140027 (Exp 12/31/2025)

24144282 (Exp 10/31/2026)

NDC:

67877-544-68

Manufactured by Alkem Laboratories Ltd., India; Distributed by Ascend Laboratories, LLC.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96912

Status: Active

Manufacturer: Ascend Laboratories, LLC

Manufactured In: India, United States

Units Affected: 2 products (48,936 - 100 mL bottles; 10,620 - 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

What You Should Do

This recall affects Cephalexin for Oral Suspension, USP (125 mg per 5 mL) sold in 100 mL and 200 mL bottles under the Ascend Laboratories brand.

Check the medication bottle label for NDC codes 67877-544-88 (100 mL bottle) or 67877-544-68 (200 mL bottle). If the NDC matches, check the lot number and expiration date printed on the container.

See the Affected Products section below for the full list of affected codes.

If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Ascend Laboratories, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Cephalexin for Oral Suspension, USP, 125 mg per 5 mL (100 mL)by Ascend Laboratories, LLC

Variants: 125 mg per 5 mL, 100 mL (when mixed)

Lot Numbers:

23141828 (Exp 5/31/2025)

23141829 (Exp 5/31/2025)

23142342 (Exp 6/30/2025)

23142708 (Exp 7/31/2025)

23144035 (Exp 10/31/2025)

23144270 (Exp 11/302025)

24140026 (Exp 12/31/2025)

NDC:

67877-544-88

Manufactured by Alkem Laboratories Ltd., India; Distributed by Ascend Laboratories, LLC.

Product: Cephalexin for Oral Suspension, USP, 125 mg per 5 mL (200 mL)by Ascend Laboratories, LLC

Variants: 125 mg per 5 mL, 200 mL (when mixed)

Lot Numbers:

23142343 (Exp 6/30/2025)

23143526 (Exp 9/30/2025)

23144036 (Exp 10/31/2025)

23144269 (Exp 11/30/2025)

24140027 (Exp 12/31/2025)

24144282 (Exp 10/31/2026)

NDC:

67877-544-68

Manufactured by Alkem Laboratories Ltd., India; Distributed by Ascend Laboratories, LLC.