Medications & Supplements/Prescription Drugs

Lannett Company, Inc.: Hydroxyzine Hydrochloride Syrup Recalled for Unknown Impurities

Agency Publication Date: October 19, 2018

Summary

Lannett Company, Inc. has recalled 8,324 bottles of Hydroxyzine Hydrochloride Syrup (Hydroxyzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, which is used to treat anxiety and allergic reactions. This recall was initiated because manufacturing cleaning procedures failed to prevent the presence of unknown impurities, causing the medication to fall outside of required safety specifications. Consumers should check their prescription bottles to see if they have the affected lot number 1097. You should contact your healthcare provider or pharmacist immediately if you have this medication.

Risk

The presence of unknown impurities means the medication does not meet quality and purity standards, which could potentially lead to unexpected side effects or reduced effectiveness of the treatment.

What You Should Do

Check your prescription bottle for Hydroxyzine Hydrochloride Syrup, 10 mg per 5 mL, with NDC 54838-502-80.
Locate the lot number and expiration date on the label to see if your bottle is from Lot 1097 with an expiration date of 10/18.
If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment.
Return any unused product from the affected lot to the pharmacy where it was purchased for a refund.
Contact Lannett Company, Inc. at their Philadelphia, PA office if you have further questions regarding this recall.
For additional information or to report a problem, 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 provider 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: HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL

Model:

NDC 54838-502-80

Recall #: D-0083-2019

Lot Numbers:

1097 (Exp 10/18)

Date Ranges: Exp 10/18

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 81225

Status: Resolved

Manufacturer: Lannett Company, Inc.

Sold By: pharmacies

Manufactured In: United States

Units Affected: 8,324 bottles

Distributed To: Nationwide

Agency Last Updated: October 29, 2018

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 prescription bottle for Hydroxyzine Hydrochloride Syrup, 10 mg per 5 mL, with NDC 54838-502-80.

Locate the lot number and expiration date on the label to see if your bottle is from Lot 1097 with an expiration date of 10/18.

If your medication matches the affected lot, contact your healthcare provider or pharmacist immediately for guidance on continuing your treatment.

Return any unused product from the affected lot to the pharmacy where it was purchased for a refund.

Contact Lannett Company, Inc. at their Philadelphia, PA office if you have further questions regarding this recall.

For additional information or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.