Hydroxyzine HCl Solution (Morton Grove) – impurity specs (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Morton Grove Pharmaceuticals, Inc.
Lot Codes / Batch Numbers
Lot#: a) UU1328, Exp 10/21, b) UU1207, Exp 07/21, UU1326, Exp 09/21, UU1327, Exp 10/21.
Products Sold
Lot#: a) UU1328, Exp 10/21; b) UU1207, Exp 07/21; UU1326, Exp 09/21; UU1327, Exp 10/21.
Morton Grove Pharmaceuticals, Inc. is recalling Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg/5 mL, packaged in a) 4 fl oz (118 mL) bo due to Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026