CLASS II Drug recall · Reported 30 Dec 2020 · FDA Enforcement Report
Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled
Morton Grove Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg, distributed nationwide in the US. The recall was initiated on 9 Dec 2020 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0174-2021
- FDA event ID
- 86904
- Recalling firm
- Morton Grove Pharmaceuticals, Morton Grove, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 9 Dec 2020
- FDA classified
- 23 Dec 2020
- Reported
- 30 Dec 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 9 Dec 2020 | Recall initiated by company | |
| 23 Dec 2020 | Classified by FDA | +14 days |
| 30 Dec 2020 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA and Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Which lots are affected?
Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
Where was it sold?
Nationwide USA and Puerto Rico
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
| Drug | CLASS II | Dexamethasone Elixir, USP 0.5 mg/, Net recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Promethazine Syrup Plain, 6.25 mg recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Valproic Acid Oral Solution USP, (250 mg/, 1 Pint recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Promethazine With Codeine Oral Solution recalled | Morton Grove Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Prednisolone Sodium Phosphate Oral Solution, 15 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
Other Hydroxyzine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | HydrOXYzine Hydrochloride Syrup recalled by Lannett CompanyHydroxyzine Hydrochloride | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydroxyzine HCl, 50mg/ml Inj MDV, Rx, Vital Care Compounder recalled | Pharmacy Plus | Sterility | MS |
| Drug | CLASS III | HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |