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Ani Pharmaceuticals, Inc.

Low risk

The FDA considers this unlikely to cause harm. Return it for a refund if you would rather not keep it.

Class III

  • Unlikely to cause any adverse health consequence, but the product breaks FDA rules.
  • Refunds don't require a receipt, and you don't need proof of purchase.
  • FDA status: Ongoing.

What was recalled

Source: FDA · synced 29 Jul 2026 13:14
Low risk Filed 2026-07-01

Presence of foreign substance

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

Check these codes: Lot S25133A

6564 bottles · distributed nationwide in the usa Recall D-0619-2026 on FDA.gov ↗
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