Class III

Drug Recall: 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

ANI Pharmaceuticals, Inc. · June 2, 2026

Reason for Recall

Presence of foreign substance

Distribution

Nationwide in the USA

States Affected

NATIONWIDE

Quantity Affected

6564 bottles

Source: FDA (openFDA Drug Enforcement)

Recall number: D-0619-2026

Status: ongoing

SafeCheck provides drug interaction information from FDA-approved product labeling (openFDA). This is for informational purposes only and is not medical advice. Always consult your healthcare provider before making medication decisions.

ANI Pharmaceuticals, Inc. Drug Recall: 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 | SafeCheck