CLASS III Drug recall · Reported 26 Jun 2013 · FDA Enforcement Report
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg recalled
Hi-Tech Pharmacal is recalling HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg, distributed nationwide in the US. The recall was initiated on 30 Apr 2013 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-603-2013
- FDA event ID
- 65047
- Recalling firm
- Hi-Tech Pharmacal, Amityville, NY
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 30 Apr 2013
- FDA classified
- 14 Jun 2013
- Reported
- 26 Jun 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 30 Apr 2013 | Recall initiated by company | |
| 14 Jun 2013 | Classified by FDA | +45 days |
| 26 Jun 2013 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent; 24 month stability test station
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
HydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 16 fl. oz. (473 mL), Rx Only, HI-TECH PHARMACAL CO., INC. AMITYVILLE, NY, NDC 50383-796-16
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
Subpotent; 24 month stability test station
Which lots are affected?
Batch 608917 (exp. 02/2014), and Batch 608204 (exp. 01/2014)
Where was it sold?
Nationwide and Puerto Rico
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.
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Other Hydroxyzine recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/ (1 Pint) recalledHydroxyzine Hydrochloride | ANI Pharmaceuticals | Other | Nationwide |
| 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 |