Recall: D-0619-2026

Class III - Minor Violations

Class IIIClassification

2026-06-02Initiated

OngoingStatus

ANI Pharmaceuticals, Inc.Firm

Product

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

Presence of foreign substance

Distribution

Nationwide in the USA

Source: FDA drug enforcement report via openFDA (Voluntary: Firm initiated). If you take this product, talk to your pharmacist or doctor before stopping it.