Class III U.S. Food and Drug Administration

ANI Pharmaceuticals, Inc. hydrOXYzine Hydrochloride Oral Solution, USP recall: Presence of foreign substance

Recall published 4 months ago

Presence of foreign substance

The hazard: Foreign material — foreign objects

Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

What the notice says: Presence of foreign substance

Why it matters: Pieces of foreign objects may be inside the product. The risk here is physical rather than microbial: cuts to the mouth or throat, a broken tooth, or an injury further down if a fragment is swallowed.

Symptoms and when to call a doctor

If someone has swallowed a fragment and has mouth or throat pain, trouble swallowing, chest or stomach pain, vomiting, or blood in saliva or stool, they should be seen the same day. A fragment swallowed without symptoms usually passes on its own, but tell the clinician exactly what the product was: whether it shows up on imaging depends entirely on the material, so describe the product and the notice to them.

This page is general information, not medical advice. If you feel unwell, a clinician who can see you is the only person able to judge your case.

Recall details

Recall number
D-0619-2026
Published
July 1, 2026
Risk level
Class III
Status
Ongoing
Issued by
U.S. Food and Drug Administration
Brand
ANI Pharmaceuticals, Inc.
Product type
Prescription & OTC drugs
Units affected
6564 bottles
Distribution
Nationwide
Made in
United States
Lot / code info
Lot S25133A

Products covered by this recall

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

Check your product

The notice names 6 codes you can read straight off the package. Type the one printed on yours and the list below narrows to it.

Lot or batch code

Usually ink-stamped near the seam, the cap or the bottom of the pack.

  • 25133A — 6564 bottles

NDC number

On the carton and again on the bottle or blister label.

  • 70954-912-10

Package size

Match the net weight or the piece count on the front of the pack.

  • 10 mg
  • 5 mL
  • 473 mL
  • 1 Pint

Codes are lifted verbatim from the FDA — Drug enforcement notice. A code that is missing here may still be covered — the official notice is the complete list.

What to do about Foreign material

ANI Pharmaceuticals, Inc. — Fragments of foreign objects may have got into this product during manufacture, which is why whole production codes are withdrawn rather than a handful of packs.

  1. Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.
  2. Keep the pack if you can. If anyone was hurt, the fragment and the packaging together are the evidence that matters.
  3. Return it to the store or bin it sealed, and claim the refund using the lot code from the label.
  4. Check the freezer and the pantry for other packs carrying the same codes before you consider the matter closed.

How to get your money back

Food recalls carry a full refund, and in the United States you usually do not need the receipt or the packaging.

  • Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.
  • Bought it online? Open the order in your account and use the refund option; marketplace sellers are required to honour a federal recall.
  • If the store refuses, contact the recalling company using the details on this page. The firm, not the shop, carries the cost of a recall.
  • If you have a loyalty card, the retailer can look the purchase up in your history — Kroger, Costco and Walmart all do this routinely.

Company contact: ANI Pharmaceuticals, Inc. — 210 W Main St, Baudette, MN, 56623-2467

The official notice

This page summarises a notice published by U.S. Food and Drug Administration. The agency notice is the authoritative version — read it before you act, and treat it as the final word if anything here looks different.

Open the FDA — Drug enforcement record U.S. Food and Drug Administration recalls

Questions people ask about this recall

Why was ANI Pharmaceuticals, Inc. prescription & otc drugs recalled?

Presence of foreign substance Presence of foreign substance

How do I know if I have the recalled product?

Match the codes printed on your package against the notice: lot code 25133A — 6564 bottles. If the code on your package is not on that list, your unit is outside the recall.

What should I do with it right now?

Stop eating it, and do not pick through it to find the fragment — sorting it by hand is how people get cut.

Can I get my money back?

Take the product, or your photo of the label, to the customer service desk of the store where you bought it. Nearly every national grocer refunds recalled food on the spot.

Where was the recalled product sold?

It was distributed nationwide.

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