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.
Presence of foreign substance
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.
The product contains a foreign substance that could pose a risk to users. This foreign material may cause adverse reactions or health issues when taken as directed. The exact nature of the foreign substance is not specified in the recall notice.
Prescription holders of the 10 mg/5 mL hydrOXYzine Hydrochloride Oral Solution (1 pint) with NDC 70954-912-10 and lot number S25133A. Individuals using this medication for medical purposes are most at risk.
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.
Verify the NDC code 70954-912-10 and lot number S25133A on the product label.
The recall states the product contains a foreign substance, but does not specify if it is safe to use. The official notice advises checking the product details for the recall.
The recall does not provide a specific remedy, so the official notice does not state what action to take.
Check the product label for NDC 70954-912-10 and lot number S25133A. This product was distributed by ANI Pharmaceuticals, Inc. in Baudette, MN.
We’ve drafted a message you can send ANI Pharmaceuticals to request your refund or repair — edit it as you like.
Subject: Recall D-0619-2026 — ANI Pharmaceuticals ANI Pharmaceuticals Hello, I own a ANI Pharmaceuticals that is covered by recall D-0619-2026 from ANI Pharmaceuticals. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
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.
