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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
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