FlaggedRx← Medication recall checkHome
Class III · Lower riskActive recall

Hydroxyzine Hydrochloride

Unlikely to cause harm — often a labeling or packaging issue.

Does this affect you?
Check your lot numberLot S25133A
Where it was soldNationwide in the USA
Find the lot number printed on your box or bottle. If it matches — and you take this medicine — call your pharmacist. Don't stop a prescribed medicine on your own.

What happened

Presence of foreign substance

What to do

  1. Check the lot number and expiry on your medicine against the recall above.
  2. Talk to your pharmacist or doctor before changing anything — don't stop on your own.
  3. Report any problems to FDA MedWatch (1-800-FDA-1088 or fda.gov/medwatch).

Who makes it

Made byANI Pharmaceuticals, Inc.
Brand nameHYDROXYZINE HYDROCHLORIDE
Generic nameHYDROXYZINE HYDROCHLORIDE
Active ingredient(s)HYDROXYZINE DIHYDROCHLORIDE
Distributed by / forANI Pharmaceuticals, Inc., Baudette, MN 56623
NDC70954-912-10
Show the full FDA record
Full product labelhydrOXYzine 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
Recalling firmANI Pharmaceuticals, Inc.
DistributionNationwide in the USA
Quantity6564 bottles
Recall initiated2026-06-02
Report date2026-07-01
Recall completed—
Recall numberD-0619-2026
ClassificationClass III
FDA statusOngoing
Origin on fileBaudette MN United States

Related

Recent drug recallsCheck another medication

Source: U.S. FDA enforcement database (openFDA). Look this up on the official FDA recalls site ↗

This is public FDA recall information, not medical advice. A recall does not always mean your specific bottle is affected. Never stop a prescribed medicine without asking your pharmacist or doctor.