Recalling firm
ANI Pharmaceuticals, Inc.
Product type
Drug
Status
Ongoing
Report date
2026-07-01
Distribution
Nationwide in the USA
Firm state
MN
Product quantity
6564 bottles
Initiated by
Voluntary: Firm initiated
Reason for recall
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
Code / lot info
Lot S25133A
Data: U.S. FDA openFDA enforcement API. Recall details are as reported by the FDA. The quality-domain mapping and severity are a SPEQ editorial interpretation of the recall reason, not an official FDA classification.