Medications & Supplements/Prescription Drugs

Ascend Cefixime Capsules Recalled for Impurity and Degradation Issues

Agency Publication Date: January 6, 2022

Summary

Ascend Laboratories, LLC is recalling 42,698 bottles of Cefixime Capsules (400 mg). This prescription antibiotic, used to treat various bacterial infections, was found to fail quality specifications for impurities and degradation during stability testing. Consumers taking this medication should consult their doctor or pharmacist immediately. No incidents or injuries have been reported in connection with this recall.

Risk

The medication failed impurity and degradation tests, which means the drug may be less effective or could contain breakdown products that do not meet safety standards. No adverse events have been reported to date.

What You Should Do

This recall affects Cefixime Capsules (400 mg) sold in 50-count bottles under the NDC 67877-584-50. The capsules were manufactured by Alkem Laboratories Ltd. and distributed by Ascend Laboratories, LLC.
Identify if your medication is affected by checking the lot number and expiration date printed on the bottle label. See the Affected Products section below for the full list of affected codes.
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Cefixime Capsules (400 mg)

Variants: 400 mg, 50-count bottle, Rx only

Lot Numbers:

20140293 (Exp Dec 2021)

20141525 (Exp Mar 2022)

20141526 (Exp Mar 2022)

20141527 (Exp Mar 2022)

20143019 (Exp July 2022)

20143020 (Exp July 2022)

20143021 (Exp July 2022)

20143022 (Exp July 2022)

20144759 (Exp Nov 22)

20144760 (Exp Nov 22)

20144761 (Exp Nov 22)

NDC:

67877-584-50

Manufactured by Alkem Laboratories Ltd., Mumbai, India. Distributed by Ascend Laboratories, LLC, Parsippany, NJ.

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89259

Status: Resolved

Manufacturer: Ascend Laboratories, LLC

Sold By: Pharmacies

Manufactured In: India, United States

Units Affected: 42,698 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 Cefixime Capsules (400 mg) sold in 50-count bottles under the NDC 67877-584-50. The capsules were manufactured by Alkem Laboratories Ltd. and distributed by Ascend Laboratories, LLC.

Identify if your medication is affected by checking the lot number and expiration date printed on the bottle label. See the Affected Products section below for the full list of affected codes.

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 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: Cefixime Capsules (400 mg)

Variants: 400 mg, 50-count bottle, Rx only

Lot Numbers:

20140293 (Exp Dec 2021)

20141525 (Exp Mar 2022)

20141526 (Exp Mar 2022)

20141527 (Exp Mar 2022)

20143019 (Exp July 2022)

20143020 (Exp July 2022)

20143021 (Exp July 2022)

20143022 (Exp July 2022)

20144759 (Exp Nov 22)

20144760 (Exp Nov 22)

20144761 (Exp Nov 22)

NDC:

67877-584-50

Manufactured by Alkem Laboratories Ltd., Mumbai, India. Distributed by Ascend Laboratories, LLC, Parsippany, NJ.