D-0619-2026 Class III Ongoing
FDA drug recall D-0619-2026 was initiated by ANI Pharmaceuticals, Inc. on June 2, 2026 and is designated Class III. Reason for recall: Presence of foreign substance The recall status is ongoing. Affected quantity: 6564 bottles.
Recall Details
- Product Type
- Drugs
- Report Date
- July 1, 2026
- Initiation Date
- June 2, 2026
- Termination Date
- N/A
- Voluntary/Mandated
- Voluntary: Firm initiated
- Product Quantity
- 6564 bottles
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
Reason for Recall
Presence of foreign substance
Distribution Pattern
Nationwide in the USA
Code Information
Lot S25133A