ANI Pharmaceuticals, Inc. recalls hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc.,…

Presence of foreign substance

Date

2026-07-01

Country

United States

Brand

ANI Pharmaceuticals

Product

hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx only, Distributed by: ANI Pharmaceuticals, Inc., Baudette,…

Classification

Class III

Units

Nationwide in the USA

Category

Drugs & medical

Source

FDA · Drug

Copied automatically from the US Food and Drug Administration. Details may be shortened or out of date; the official notice is the authoritative source. Disclaimer

What to do

1. Check the product name, strength and lot number against the official notice.
2. Do not stop a prescribed medicine without talking to your doctor or pharmacist first.
3. Ask the pharmacy or supplier about a replacement or refund.

General guidance from Recall Atlas. The official notice from the US Food and Drug Administration has the exact models, batch codes and remedy, and it takes priority.

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