hydrOXYzine Hydrochloride Oral Solution recall
FDA recall D-0619-2026 · initiated Jun 2, 2026
ANI Pharmaceuticals, Inc. recalled hydrOXYzine Hydrochloride Oral Solution in Jun 2026 — an FDA Class III recall (D-0619-2026) because Presence of foreign substance.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Presence of foreign substance
Something got into the product
A physical or chemical contaminant was found — glass or metal fragments, or a solvent that should not be there.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 6564 bottles
Details
- Product
- 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
- Recalling company
- Ani Pharms Inc
- Classification
- Class III
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Jun 2, 2026
- FDA report date
- Jul 1, 2026
Frequently asked
- Was hydrOXYzine Hydrochloride Oral Solution recalled?
- ANI Pharmaceuticals, Inc. recalled hydrOXYzine Hydrochloride Oral Solution in Jun 2026 — an FDA Class III recall (D-0619-2026) because Presence of foreign substance. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was hydrOXYzine Hydrochloride Oral Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0619-2026 was: Presence of foreign substance
- Is a recalled hydrOXYzine Hydrochloride Oral Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of hydrOXYzine Hydrochloride Oral Solution are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot S25133A. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0619-2026.