drugs LOW RISK Updated 2026-07-01

ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 47

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Recalled Product

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

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Hazard / Issue

Presence of foreign substance

Issued by

FDA

Distribution: Nationwide (United States)
Lot/Code Info: Lot S25133A

✅ What Should You Do?

  1. 1Stop taking this medication and contact your doctor or pharmacist immediately.
  2. 2Do NOT flush medications down the drain — use an FDA-approved drug take-back program.
  3. 3Check the lot number on your bottle or packaging against the recalled lots listed above.
  4. 4Report adverse events to FDA MedWatch or call 1-800-FDA-1088.
View official government recall