Hydroxyzine Hydrochloride Oral Solution — Class II drug recall D-0174-2021
Terminated recall by Morton Grove Pharmaceuticals, Inc., reported 2020-12-30, distributed nationwide. Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzop
| Recall number | D-0174-2021 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Morton Grove Pharmaceuticals, Inc., Morton Grove, IL, United States |
| Recall initiated | 2020-12-09 |
| Classified | 2020-12-23 |
| Reported by FDA | 2020-12-30 |
| Terminated | 2022-09-24 |
| Distributed | Nationwide (US) |
| Quantity | 127,392 bottles |
| Reason classes | specification failure |
| NDC | 60432-0150-04, 60432-0150-16 |
Product
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
Reason for recall
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0174-2021. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.