hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals,
Summary
The FDA issued a Class III for hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx on by ANI Pharmaceuticals, Inc.. Reason: Presence of foreign substance.
Details
Source
Drug Recall
External ID
D-0619-2026
Action Date
2026-07-01
Status
Ongoing
Category
drug
Product Description
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
Lot/Code Info: Lot S25133A
Quantity Affected: 6564 bottles
Reason for Recall
Presence of foreign substance
Distribution
Nationwide in the USA
Type: Voluntary: Firm initiated
Recall Initiated: 2026-06-02
Company
Baudette, MN
Context & Analysis
This is a Class III recall. Class III recalls involve products unlikely to cause adverse health consequences, but that violate FDA regulations.
This was one of 49 drug recalls issued in the same week, part of 60 drug-related FDA actions this month.
ANI Pharmaceuticals, Inc. has 7 FDA actions in our database, including 7 recalls.
Frequently Asked Questions
What is a Class III recall?
A Class III recall involves products that are unlikely to cause adverse health effects but violate FDA labeling or manufacturing regulations.
What should I do if I have this product?
Stop using the product. Check the product against the specific lot numbers or identifiers listed in the recall. Contact the manufacturer (ANI Pharmaceuticals, Inc.) or your retailer for a refund or replacement. If you experienced adverse effects, report them to the FDA via MedWatch.
How often does ANI Pharmaceuticals, Inc. have FDA actions?
ANI Pharmaceuticals, Inc. has 7 FDA actions in our database, including 7 recalls and 0 device clearances.
Where can I find the official FDA record?
The official record is available on FDA.gov. Search for "D-0619-2026" on FDA.gov for the full record. You can also use the openFDA API to query this record programmatically.
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