Unrated Drug recall · FDA · Published June 2, 2026

ANI Pharmaceuticals recalls hydrOXYzine oral solution due to foreign substance

ANI Pharmaceuticals recalls 10 mg/5 mL hydrOXYzine Hydrochloride Oral Solution (1 pint) due to foreign substance presence. Rx only product distributed by ANI Pharmaceuticals, Inc. in Baudette, MN. NDC: 70954-912-10, Lot S25133A.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0619-2026Drug ANI Pharmaceuticals ›

Recall notice

Presence of foreign substance

Take action

Contact the company

Recalling firmANI Pharmaceuticals, Inc.210 W Main St · Baudette, MN 56623-2467

✎ GovInfoNow plain-language explainer

ANI Pharmaceuticals is recalling a specific hydrOXYzine oral solution product because it contains a foreign substance. This recall affects prescription-only medication distributed by ANI Pharmaceuticals, Inc. in Baudette, MN. Read more at govinfonow.com/recall/31241-ani-pharmaceuticals-recalls-hydroxyzine-oral-solution-due-to-foreign-substance.

Source Summary by GovInfoNow · govinfonow.com/recall/31241-ani-pharmaceuticals-recalls-hydroxyzine-oral-solution-due-to-foreign-substance · Updated August 10, 2026 · FDA enforcement record: FDA #D-0619-2026

Cite this page

“ANI Pharmaceuticals recalls hydrOXYzine oral solution due to foreign substance.” GovInfoNow, updated August 10, 2026. https://govinfonow.com/recall/31241-ani-pharmaceuticals-recalls-hydroxyzine-oral-solution-due-to-foreign-substance. Based on FDA recall #D-0619-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0619-2026%22&limit=1).

The FDA announced on June 2, 2026, that ANI Pharmaceuticals is recalling hydrOXYzine Hydrochloride Oral Solution due to the presence of a foreign substance. The agency issued recall number D-0619-2026 for the nationwide distribution of the drug.

How to tell if you have it

Brand: ANI Pharmaceuticals
Product: hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint)
NDC: 70954-912-10
Lot code: S25133A
Quantity: 6564 bottles

The hazard

The recall is due to the presence of a foreign substance in the hydrOXYzine Hydrochloride Oral Solution. The FDA classified this as a Class III recall.

Context

ANI Pharmaceuticals has three other recalls on record since October 9, 2020, including a May 12, 2026, recall of Estradiol Gel due to defective containers and a February 15, 2022, recall of Alprazolam Tablets for manufacturing deviations. Other recent recalls of similar products include Graviti Furosemide Tablets Recall (January 10, 2026), Taro Recalls Children's Ibuprofen (March 2, 2026), and Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026).

How to tell if you have this one

Check for the product name 'hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint)' with NDC 70954-912-10 and lot number S25133A. This prescription-only medication was distributed by ANI Pharmaceuticals, Inc. in Baudette, MN.

Brand
ANI Pharmaceuticals
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Verify the NDC code 70954-912-10 and lot number S25133A on the product label.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide in the USA” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 29 days after the firm started it.

Jun 2, 2026Firm started the recall
Jun 24, 2026FDA classified it Class III
Jul 1, 2026Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31241-ani-pharmaceuticals-recalls-hydroxyzine-oral-solution-due-to-foreign-substance">ANI Pharmaceuticals recalls hydrOXYzine oral solution due to foreign substance (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0619-2026 (June 2, 2026) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0619-2026 to see it in context.
Plain-language summary written by qwen3:4b on August 10, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.