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DRUG RECALLLOW
Hydroxyzine Hydrochloride Oral Solution
ANI Pharmaceuticals is recalling Hydroxyzine Hydrochloride Oral Solution, 10 mg/5 mL, due to the presence of a foreign substance.
What to do
Stop using the product immediately and contact your pharmacist or healthcare provider for further instructions.
Recall at a glance
- Quantity recalled
- 6564 bottles
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
- Lot code
- 25133A
- Strength
- 10 mg
- NDC / UPC
- NDC 70954-912-10
Where it was sold
Distributed nationwide.
Timeline
- Firm initiated recall
- Publicly announced
- Listed on Recall Canary
- Summary updated
Official source
Other Foreign Material recalls
Other recent recalls from ANI Pharmaceuticals, Inc.
Editorial summary by Recall Canary · summary updated 2026-06-25 · primary source: U.S. Food and Drug Administration · severity reflects the agency's published classification