hydrOXYzine Hydrochloride Oral Solution recall
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
Why was hydrOXYzine Hydrochloride Oral Solution recalled?
Presence of foreign substance
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
Lot S25133A
- 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
- Recalling firm
- ANI Pharmaceuticals, Inc.
- Quantity
- 6564 bottles
- Distribution
- Nationwide in the USA
- Recall date
- July 1, 2026
- Classification
- Class III
- Status
- Ongoing
- Agency
- FDA (drug)