ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution
- Recalling company
- ANI Pharmaceuticals, Inc.
- 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
- Classification
- Class III – not likely to cause adverse health consequences
- Recall date
- Jun 2, 2026
- Reported
- Jul 1, 2026
- Distribution
- Nationwide in the USA
- Status
- Ongoing
- Quantity
- 6564 bottles
- Lot / codes
- Lot S25133A
- Company location
- Baudette, MN
- Recall type
- Voluntary: Firm initiated
- Recall number
- D-0619-2026
- Agency
- U.S. Food and Drug Administration (FDA)
View official FDA notice ↗ Search recall number D-0619-2026 in the FDA Enforcement Report. Also see FDA recall press releases.
If you use this product, check the lot, NDC or model number against the official notice and follow its instructions. Do not stop a prescribed medicine or remove a medical device without talking to your doctor or pharmacist. Report problems to FDA MedWatch. FoodRecallNow summarizes public FDA data and is not medical advice.