hydrOXYzine Hydrochloride Oral Solution, 10 mg/5 mL recall — Ani Pharmaceuticals, Inc. (Class III)

Regulatory snapshot

Reason reported by FDA

Presence of foreign substance

4 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

6 identifying values matched by exact pattern in the 24-word product description above; each is a literal substring of it.

Reading this record

Class III is the FDA's own severity tier for the recall action — 25 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. Match a package against 70954-912-10 at the FDA source to confirm it is covered.

Namespace context: the Class III index (25 records) and the recall hub (250 records, 118 FDA events); Ani Pharmaceuticals, Inc. (2 indexed records) aggregates this firm across datasets.

• What "Ongoing" recall status means
• How to search FDA drug recalls by NDC
• How to monitor a manufacturer’s recall history
• FDA recall classifications: Class I, II and III

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0619-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.