Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
Hydroxyzine Hydrochloride Oral Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Cause type: Impurity / degradation
An impurity or degradation product above its limit - other than nitrosamines. Unexpected substances in a batch can make it unsafe or less effective, even when the active ingredient is present. All impurity / degradation recalls.
What was recalled
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC 60432-150-04, b) 1 pint (473 mL), NDC 60432-150-16, Rx Only, Manufactured By: Morton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Affected NDCs
60432-0150-04
60432-0150-16
Compare with the code on your package — it is the most precise check available.
Drug: Hydroxyzine
- Recalling firm
- Morton Grove Pharmaceuticals, Inc.
- NDC code
- 60432-150-04
- Origin
- IL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0174-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydroxyzine recalls
See all
Class II · Moderate risk
HydrOXYzine Pamoate Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
HydrOXYzine HYDROCHLORIDE SYRUP
CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Class II · Moderate risk
Hydroxyzine HCl
Lack of Assurance of Sterility
Class II · Moderate risk
All hydroxyzine Products
Lack of Processing Controls
Other recalls by Morton Grove Pharmaceuticals, Inc.
All 2020 recalls
Class II · Moderate risk
Dexamethasone Elixir
Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impurities were found in the drug product.
Class II · Moderate risk
Valproic Acid Oral Solution USP
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine With Codeine Oral Solution
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
Class II · Moderate risk
Promethazine Syrup Plain
CGMP Deviations: Potential concern with products manufactured using liquid sugar batches contaminated with microbial organisms.
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