FDA-Drug2026-07-01Class IIIPROCESSING DEFECT
ANI Pharmaceuticals hydroxyzine oral solution recalled for foreign substance contamination
What this means
ANI Pharmaceuticals is recalling hydroxyzine hydrochloride oral solution (10 mg/5 mL, 473 mL bottles) due to the presence of a foreign substance in one lot. The affected product was distributed nationwide. No injuries have been reported.
- Check if you have hydroxyzine oral solution lot S25133A (NDC 70954-912-10).
- Stop using the product and contact your pharmacy or healthcare provider.
- Do not flush or throw away the medication; ask your pharmacist how to safely dispose of it.
The agency's original wording
Hazard
Presence of foreign substance
Intended for
Adults
Illnesses reported
None reported
Sold states
Nationwide in the USA
Affected count
6564 bottles
Manufactured in
210 W Main St, N/A, Baudette, MN, United States
Products
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
Official notice
https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0619-2026Want us to check the next one for you?
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