FDA recall, , Low risk
ANI Pharmaceuticals Hydroxyzine Hydrochloride Oral Solution
HydrOXYzine Hydrochloride Oral Solution contains a foreign substance.
Summary by Recall Canary from the FDA notice
What happened
ANI Pharmaceuticals, Inc., of Baudette, Minnesota, recalled hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, due to the presence of a foreign substance. The recall began June 2, 2026, and the product was distributed nationwide in the USA.
The recalled product is identified as hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, distributed by ANI Pharmaceuticals, Inc., Baudette, MN 56623. The FDA added the recall to its Enforcement Report on June 24, 2026, and it was in the FDA's weekly enforcement report on July 1, 2026.
What to do
We don't have product-specific instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
hydrOXYzine Hydrochloride Oral Solution
- NDC
- 70954-912-10
- Lot code
- 25133A
Recall details
- Company began the recall
- Sold in
Nationwide in the USA
- Company
- ANI Pharmaceuticals, Inc.Baudette, Minnesota
- Hazard
- Foreign object
- Risk
Low risk
Taking it is unlikely to cause health problems.
FDA Class III recall · How risk is rated
- Event ID
- 99131
- Recall number
- D-0619-2026
- Quantity recalled
- 6564 bottles
All recalls from ANI Pharmaceuticals, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA adds a recall when it posts it and publishes the list weekly.
Company began the recall
Added to FDA's Enforcement Report · Classified by FDA
Listed on Recall Canary
In FDA's weekly enforcement report
Summary updated
