Hydroxyzine Hydrochloride Oral Solution
ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance.
Stop using the product immediately and contact your pharmacist or healthcare provider for further instructions.
Why it was recalled
ANI Pharmaceuticals is recalling one lot of Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance in the product.
Is mine affected?
Check the NDC or UPC and strength printed on the package. Yours is affected if it matches one below.
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
- Recall #
- D-0619-2026
Where it was sold
Distributed nationwide.
Official source
Other recent recalls from ANI Pharmaceuticals, Inc.
Editorial summary by Recall Canary · last updated 2026-06-25 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification