Reported Dec 30, 2020 · Terminated

Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bottle, NDC…

Morton Grove Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Morton Grove Pharmaceuticals, Inc. · 6451 Main St · Morton Grove, IL · 60053-2633

Is this the product you have?

    • 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 ByMorton Grove Pharmaceuticals, Inc., Morton Grove, IL 60053
Lot codes and dates
    • Lot#: a) UU1328
    • Exp 10/21
    • b) UU1207
    • Exp 07/21
    • UU1326
    • Exp 09/21
    • UU1327
    • Exp 10/21
Amount recalled
127,392 bottles

Where it was sold

  • Nationwide
  • PR

Why it was recalled

Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.

This product could cause temporary or reversible health problems — stop using it.

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Where this came from

Source: U.S. Food & Drug Administration (openFDA)

Read the FDA (openFDA drug enforcement) notice

Notice updated Sep 24, 2022 · Data as of Sep 19, 8:06 PM UTC

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