CLASS III ONGOING Drug recall · Reported 1 Jul 2026 · FDA Enforcement Report
hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalled
ANI Pharmaceuticals is recalling hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint), distributed nationwide in the US. The recall was initiated on 2 Jun 2026 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0619-2026
- FDA event ID
- 99131
- Recalling firm
- ANI Pharmaceuticals, Baudette, MN
- Manufacturer
- ANI Pharmaceuticals, Inc.
- Classification
- Class III
- Status
- Ongoing
- Recall initiated
- 2 Jun 2026
- FDA classified
- 24 Jun 2026
- Reported
- 1 Jul 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Anxiety & Sleep Medication
Timeline
| 2 Jun 2026 | Recall initiated by company | |
| 24 Jun 2026 | Classified by FDA | +22 days |
| 1 Jul 2026 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of foreign substance
Product as listed by the FDA
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
Where it was distributed
Nationwide in the USA
Questions about this recall
Why was it recalled?
Presence of foreign substance
Which lots are affected?
Lot S25133A
Where was it sold?
Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ANI Pharmaceuticals
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Estradiol Gel, 0.1%, 0.25 mg per packet, 30 packets recalledEstradiol | ANI Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP 1.0 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP 2.0 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pyrazinamide Tablets, USP 500 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Alprazolam Tablets, USP 0.25 mg recalled by ANI Pharmaceuticals | ANI Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Hydroxyzine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydroxyzine Hydrochloride Oral Solution, USP (Syrup), 10 mg recalled | Morton Grove Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | HydrOXYzine Hydrochloride Syrup recalled by Lannett CompanyHydroxyzine Hydrochloride | Lannett | Potency & Assay | Nationwide |
| Drug | CLASS II | Hydroxyzine HCl, 50mg/ml Inj MDV, Rx, Vital Care Compounder recalled | Pharmacy Plus | Sterility | MS |
| Drug | CLASS III | HydrOXYzine Hydrochloride Tablets, USP 25 mg recalled | Qualitest Pharmaceuticals | Other | Nationwide |
| Drug | CLASS II | Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |