Class III · Low risk
hydrOXYzine Hydrochloride Oral Solution
Presence of foreign substance
HydrOXYzine Hydrochloride Tablets
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Failed Tablet/Capsule Specifications; The identification codes on some tablets may be unreadable
Cause type: Failed specification
A physical or chemical test other than potency, dissolution, impurity or stability failed - pH, viscosity, appearance, tablet integrity, fill volume. A product outside its own specification may not perform as designed, even if the active ingredient is present. All failed specification recalls.
What was recalled
HydrOXYzine Hydrochloride Tablets, USP 25 mg, Rx only, 100 count (NDC 0603-3968-21), 500 count (NDC 0603-3968-28) and 1000 count (NDC 0603-3968-32) bottles, Manufactured for Qualitest Pharmaceuticals, Huntsville, AL
Affected NDCs
0603-3968-21
0603-3968-28
0603-3968-32
Compare with the code on your package — it is the most precise check available.
Drug: Hydroxyzine
- Recalling firm
- Qualitest Pharmaceuticals
- NDC code
- 0603-3968-21
- Origin
- AL, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-1239-2015 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Hydroxyzine recalls
See all
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
Other recalls by Qualitest Pharmaceuticals
All 2015 recalls
Class III · Low risk
Allopurinol Tablets
Failed Tablet/Capsule Specifications; report of oversized and discolored tablets
Class III · Low risk
Disulfiram tablets
Failed Dissolution Specifications: During routine stability testing at the 12 month time point, one product lot was found to be out of specification for dissolution.
Class III · Low risk
Promethazine Vc With Codeine Syrup
Failed Impurities/Degradation Specifications: A stability lot was out of specification for a known impurity at the 8 month Controlled Room Temperature stability time-point.
Class II · Moderate risk
Promethazine Dm Syrup
Presence of Foriegn Substance: Plastic cap closure particulates may be present in the product.
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