Information
ANI Pharmaceuticals Recalls hydrOXYzine Hydrochloride Oral Solution
This is a Class III recall. This product is unlikely to cause adverse health reactions but violates FDA regulations.
Source: FDA
InfoRecall #D-0619-2026Drug / Pharmaceutical
ANI Pharmaceuticals Recalls hydrOXYzine Hydrochloride Oral Solution
ANI Pharmaceuticals, Inc. · Class III — Regulatory
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
Reason for Recall
Presence of foreign substance
FDA Classification
Class III — Regulatory
A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Distribution
Nationwide in the USA
Remedy
Consumers should stop using this product. Contact the recalling firm for further instructions regarding this product.
411 Press Analysis
A regulatory compliance recall has been issued for a pharmaceutical product from ANI Pharmaceuticals, Inc. The FDA classified this as Class III on June 2, 2026 affecting 6564 bottles. Presence of foreign substance. It was distributed nationwide. While this classification indicates a low probability of adverse health effects, consumers should be aware of the recall and follow any instructions from the manufacturer.
Sources: FDA openFDA Enforcement Database
This recall appears in: Drug & Medical Product Contamination.