CLASS II Drug recall · Reported 17 Jun 2015 · FDA Enforcement Report
Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn
Akorn is recalling Hydroxyzine Hydrochloride, oral solution, 10 mg per, distributed nationwide in the US. The recall was initiated on 7 Apr 2015 and the FDA has classified it as Class II.
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-1129-2015
- FDA event ID
- 71033
- Recalling firm
- Akorn, Lake Forest, IL
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 7 Apr 2015
- FDA classified
- 9 Jun 2015
- Reported
- 17 Jun 2015
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Anxiety & Sleep Medication
Timeline
| 7 Apr 2015 | Recall initiated by company | |
| 9 Jun 2015 | Classified by FDA | +63 days |
| 17 Jun 2015 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
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, 10 mg per 5 mL, 16 fl oz (473 ml) bottle, Rx only, Manufactured for KVK-Tech, Inc., Newtown, PA by Hi-Tech Pharmacal Co., Inc., Amityville, NY, NDC 10702-0052-16
Where it was distributed
Nationwide including Puerto Rico
Questions about this recall
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Lot# 621637, 621640 Exp 05/2015; 622748, 622751 Exp 08/2015; 623599, 623602 Exp 09/2015; 624132, 624135 Exp 10/2015; 628282, 628285, 628288, 628291 Exp 06/2016; 628850, 628853, 628856, 628859 Exp 07/2016, 629797, 629800, 629803, 629806 Exp 09/2016
Where was it sold?
Nationwide including 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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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.
Other products in this recall event
1 other product · FDA event 71033This product is part of a recall event; the main page for the event is Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Hydroxyzine Hydrochloride, oral solution, 10 mg recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Calcipotriene Topical Solution, 0.005% (Scalp Solution) recalled | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Midazolam Injection, USP, 50 mg/ (5mg/mL) recalled by Akorn | Akorn | Potency & Assay | Nationwide |
| Drug | CLASS II | Lidocaine Ointment USP, 5%, 1 tubes recalled by Akorn | Akorn | Potency & Assay | Nationwide |
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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 |