Medications & Supplements/Prescription Drugs

Lannett Diazepam Oral Solution Recalled Due to Failed Impurity Specifications

Agency Publication Date: February 14, 2022

Summary

Lannett Company, Inc. is voluntarily recalling 23,598 bottles of Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), because the medication failed to meet safety standards for impurities. The recall affects 30 mL bottles that were distributed nationwide. No incidents or injuries have been reported to date, but the medication may have degraded over time. If you use this medication, you should consult your healthcare provider or pharmacist about a replacement.

Risk

The medication was found to have impurities or degradation products that exceed safety specifications. This could potentially reduce the effectiveness of the treatment or cause unexpected side effects.

What You Should Do

The recalled product is Lannett Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), sold in 30 mL bottles under NDC 0527-1768-36.
Check the lot number and expiration date printed on your medication bottle or outer carton. The affected lot numbers are 2664A and 2664B with expiration dates of 07/2022, and 2874A and 2874B with expiration dates of 01/2023.
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 Lannett Company, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions 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: Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL) (30 mL)

Variants: 5 mg/mL, 30 mL BOTTLE and DROPPER, Rx Only

Lot Numbers:

2664A (Exp 07/2022)

2664B (Exp 07/2022)

2874A (Exp 01/2023)

2874B (Exp 01/2023)

NDC:

0527-1768-36

Recall #: D-0558-2022

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 89551

Status: Resolved

Manufacturer: Lannett Company, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 23,598 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

The recalled product is Lannett Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), sold in 30 mL bottles under NDC 0527-1768-36.

Check the lot number and expiration date printed on your medication bottle or outer carton. The affected lot numbers are 2664A and 2664B with expiration dates of 07/2022, and 2874A and 2874B with expiration dates of 01/2023.

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 Lannett Company, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.