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FDA · Drugs ·

hydrOXYzine Hydrochloride Oral Solution recall

ANI Pharmaceuticals, Inc. recalled hydrOXYzine Hydrochloride Oral Solution on July 1, 2026 because of presence of foreign substance. It was sold nationwide.

Why it was recalled

Presence of foreign substance

What's recalled

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

Quantity: 6564 bottles

What to do

Check whether you have the product (match the lot numbers, dates or codes in the official notice). Stop using it, and return it or throw it away as the notice says.

Read the official FDA notice

Details

Company
ANI Pharmaceuticals, Inc., Baudette, MN
Date
Severity
Class III
the product is unlikely to cause health problems but breaks a rule.
Where sold
Nationwide
Nationwide in the USA
Status
Ongoing
Recall number
D-0619-2026
Source
U.S. Food and Drug Administration

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