Medications & Supplements/Prescription Drugs

Morton Grove Pharmaceuticals, Inc.: Hydroxyzine Hydrochloride Oral Solution Recalled for Impurities

Agency Publication Date: December 23, 2020

Summary

Morton Grove Pharmaceuticals is recalling approximately 127,392 bottles of Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, a prescription medication used to treat anxiety and itching. This recall was initiated because the product failed quality tests for impurities and degradation, specifically showing out-of-specification levels for an unknown substance and 4-chlorobenzophenone. These impurities mean the medication may not meet safety and quality standards over time. Consumers should contact their healthcare provider or pharmacist to discuss alternatives and instructions for returning the product.

Risk

The presence of unknown impurities and 4-chlorobenzophenone indicates that the chemical stability of the medication has been compromised, which could potentially lead to reduced effectiveness or unintended side effects.

What You Should Do

Check your medicine cabinet for Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, in either 4 fl oz (118 mL) or 1 pint (473 mL) bottles.
For 4 fl oz bottles (NDC 60432-150-04), look for Lot UU1328 with an expiration date of 10/21.
For 1 pint bottles (NDC 60432-150-16), look for Lot UU1207 (Exp 07/21), Lot UU1326 (Exp 09/21), or Lot UU1327 (Exp 10/21).
Contact your healthcare provider or pharmacist for guidance on alternative treatments and to confirm if your specific bottle is affected.
Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund and contact Morton Grove Pharmaceuticals at 1-847-967-5600 for further instructions.
Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Your Remedy Options

Full Refund

Contact healthcare provider or pharmacist and return product.

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 Oral Solution, USP (Syrup), 10 mg/5 mL (4 fl oz / 118 mL)

Model:

NDC 60432-150-04

Lot Numbers:

UU1328 (Exp 10/21)

Product: Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL (1 pint / 473 mL)

Model:

NDC 60432-150-16

Lot Numbers:

UU1207 (Exp 07/21)

UU1326 (Exp 09/21)

UU1327 (Exp 10/21)

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86904

Status: Resolved

Manufacturer: Morton Grove Pharmaceuticals, Inc.

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 127,392 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

Check your medicine cabinet for Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, in either 4 fl oz (118 mL) or 1 pint (473 mL) bottles.

For 4 fl oz bottles (NDC 60432-150-04), look for Lot UU1328 with an expiration date of 10/21.

For 1 pint bottles (NDC 60432-150-16), look for Lot UU1207 (Exp 07/21), Lot UU1326 (Exp 09/21), or Lot UU1327 (Exp 10/21).

Contact your healthcare provider or pharmacist for guidance on alternative treatments and to confirm if your specific bottle is affected.

Return any unused portion of the recalled medication to the pharmacy where it was purchased for a refund and contact Morton Grove Pharmaceuticals at 1-847-967-5600 for further instructions.

Contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional questions.

Affected Products

Product: Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL (4 fl oz / 118 mL)

Model:

NDC 60432-150-04

Lot Numbers:

UU1328 (Exp 10/21)

Product: Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL (1 pint / 473 mL)

Model:

NDC 60432-150-16

Lot Numbers:

UU1207 (Exp 07/21)

UU1326 (Exp 09/21)

UU1327 (Exp 10/21)