Why it was recalled
Presence of foreign substance
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
Lot numbers, UPCs & expiration codes
Lot S25133A
Where it was sold
Nationwide in the USA
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0619-2026
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- Jun 2, 2026
- FDA report date
- Jul 1, 2026
- Quantity
- 6564 bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- ANI Pharmaceuticals, Inc.
Original FDA data
Every field from FDA enforcement report D-0619-2026, exactly as published.
Show all FDA fields
- City
- Baudette
- State
- MN
- Status
- Ongoing
- Country
- United States
- Event ID
- 99131
- Address
- 210 W Main St
- Code information
- Lot S25133A
- Postal code
- 56623-2467
- Report date
- Jul 1, 2026
- Product type
- Drugs
- Recall number
- D-0619-2026
- Classification
- Class III
- Recalling firm
- ANI Pharmaceuticals, Inc.
- Product quantity
- 6564 bottles
- Reason for recall
- Presence of foreign substance
- Voluntary / mandated
- Voluntary: Firm initiated
- 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
- Distribution pattern
- Nationwide in the USA
- Recall initiation date
- Jun 2, 2026
- Initial firm notification
- Letter
- Center classification date
- Jun 24, 2026