Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
Is Hydroxyzine recalled?
Yes — there is an active recall. 1 ongoing FDA recall mention Hydroxyzine (24 total). Check the affected lots below.
Most common reason: Unapproved drug (7 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Hydroxyzine. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Hydroxyzine recalls in 2026
1 initiated in 2026, 24 in total — newest first
Class II · Moderate risk
HydrOXYzine Pamoate Capsules
cGMP deviations: Temperature abuse
Class II · Moderate risk
Hydroxyzine Hydrochloride Oral Solution
Failed Impurities/Degradation Specification: OOS for the following - unknown degradant/impurity, 4-chorobenzophenone, and for total impurities.
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
Class III · Low risk
HydrOXYzine Hydrochloride Tablets
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Class II · Moderate risk
Hydroxyzine Hydrochloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyzine Hydrochloride
Lack of Assurance of Sterility
Class II · Moderate risk
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Hydroxyzine Hydrochloride
Failed Impurities/Degradation Specifications
Class II · Moderate risk
Hydroxyzine HCl active pharmaceutical ingredient packaged in…
Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin.
Class II · Moderate risk
Hydroxyzine hydrochloride 25 mg/mL injectable packaged in an amber glass injectable vial
Lack of Assurance of Sterility: Martin Avenue Pharmacy, Inc. is conducting a voluntary recall of all compounded sterile preparations within expiry. The recall is being initiated in connection with a recent FDA inspection due to observations associated with certain quality control procedures that present a risk to sterility assurance.
Class II · Moderate risk
HydrOXYzine Hydrochloride Oral Solution
Failed Impurity/Degradation Specification; out-of-specification result for one individual unknown impurity at the 24-month room temperature stability test station.
Class II · Moderate risk
HydrOXYzine HCl Tablets
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk
HydrOXYzine HCl Tablets
Good Manufacturing Practices Deviations: The product has an active pharmaceutical ingredient from an unapproved source.
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 25 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
Teva Hydroxyzine Pamoate Capsules
CGMP Deviations: Hydroxyzine Pamoate Capsules, USP, 100 mg were manufactured using an unapproved material: API was incorrectly released for use in manufacturing.
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 50 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 25 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk
HydrOXYzine HCI Tablets USP 10 mg
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Class II · Moderate risk
hydrOXYzine PAMOATE
Labeling: Label Mixup: hydrOXYzine PAMOATE, Capsule, 100 mg may have potentially been mislabeled as one of the following drugs: CALCIUM CITRATE, Tablet, 950 mg (200 mg Elemental Calcium), NDC 00904506260, AD46257_43, EXP: 5/15/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W002734, EXP: 6/6/2014; guaiFENesin ER, Tablet, 600 mg, NDC 45802049878, Pedigree: W003689, EXP: 6/26/20
Class III · Low risk
HydrOXYzine Hydrochloride Oral Solution
Subpotent; 24 month stability test station
Class III · Low risk
Hydroxyzine Hydrochloride Oral Solution
Impurities/Degradation Products: High Out of Specification results for a known impurity resulted at the 12-month room temperature time point.
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