thejoe Hydroxyzine Hydrochloride

Hydroxyzine Hydrochloride recalls: 5 FDA reports

Recalls involving Hydroxyzine Hydrochloride. What was wrong with each batch, and how the FDA graded the risk.

5Reports

0Class I

1Ongoing

2026-07-01Most recent

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	4
Class III	1

By year reported

Year	Reports
2014	3
2018	1
2026	1

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharma

D-0619-2026 · Class III · reported 2026-07-01 · Ongoing

Why it was recalled: Presence of foreign substance
Product: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623. NDC: 70954-912-10
Where it went: Nationwide in the USA
How much: 6564 bottles

HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Dist

D-0083-2019 · Class II · reported 2018-10-31 · Terminated

Why it was recalled: CGMP Deviations: cleaning procedures during manufacturing caused out of specification results for unknown impurities.
Product: HydrOXYzine HYDROCHLORIDE SYRUP (HydrOXYzine Hydrochloride Oral Solution, USP), 10 mg per 5 mL, Rx only, Distributed by Lannett Company, Inc., Philadelphia, PA 19154, NDC 54838-502-80.
Where it went: Nationwide in the USA
How much: 8,324 bottles

HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #

D-1030-2014 · Class II · reported 2014-01-29 · Terminated

Why it was recalled: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Product: HydrOXYzine HCI Tablets USP 10 mg, 100 count bottles, Rx only. Mfd by KVK-TECH, INC, Newtown, PA 18940. NDC #10702-010-01.
Where it went: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
How much: 14664 bottles

HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown,

D-1031-2014 · Class II · reported 2014-01-29 · Terminated

Why it was recalled: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Product: HydrOXYzine HCI Tablets USP 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.
Where it went: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
How much: 249,096 bottles

HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown,

D-1032-2014 · Class II · reported 2014-01-29 · Terminated

Why it was recalled: Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Product: HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.
Where it went: Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
How much: 104551 bottles

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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