Notice names this product. ANI Pharmaceuticals’s hydrOXYzine Hydrochloride Oral Solution is named in FDA Class III recall D-0619-2026. Your particular item is not yet verified. Compare the identifiers and exclusions in the notice before deciding whether it applies. Agency-reported hazard: Presence of foreign substance Identifying details: Lot S25133A. Units affected: 6564 bottles. Status: Ongoing.
This notice names a product; your particular item is not yet verified. Compare every applicable model, serial, lot, production-date or model-year boundary below.
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
Still to verify: match the label on your item with the full official notice, including any exclusions, tables and photos. Some identifiers appear only on the agency website and are absent from this data feed. A missing field does not mean all versions are affected.
If your lot or date falls outside a stated range, this notice has not established that your item is affected. This is not a finding about other recalls or product safety.
Presence of foreign substance
Company / brand: ANI Pharmaceuticals
Affected product: hydrOXYzine Hydrochloride Oral Solution
Official ID D-0619-2026 · Official record ↗
See all ANI Pharmaceuticals recalls →
Found something wrong or missing? Report a data error.
Compiled from connected official public-domain government data. Sources last checked September 7, 2026 at 6:00 AM UTC.