FDA Drugs recall ·
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint)… recall
- Recall number
- D-0619-2026
- Date
- (initiated June 2, 2026)
- Company / brand
- ANI Pharmaceuticals, Inc.
210 W Main St, Baudette, MN, United States - Category
- Drugs › Class III
- Classification
- Class III
- Status
- Ongoing
- Units affected
- 6564 bottles
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
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
Why was it recalled?
Presence of foreign substance
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot S25133A
Distribution
Nationwide in the USA
What does Class III mean?
Class III means use of or exposure to the product is not likely to cause adverse health consequences (for example, a labeling violation).
Source: FDA (drugs), recall D-0619-2026. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.