CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report
HydrOXYzine HCI Tablets USP 50 mg recalled by KVK-Tech
Kvk-Tech is recalling HydrOXYzine HCI Tablets USP 50 mg, 100, 500, distributed nationwide in the US. The recall was initiated on 11 Dec 2013 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-1032-2014
- FDA event ID
- 67103
- Recalling firm
- Kvk-Tech, Newtown, PA
- Manufacturer
- KVK-Tech, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2013
- FDA classified
- 22 Jan 2014
- Reported
- 29 Jan 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Anxiety & Sleep Medication
Timeline
| 11 Dec 2013 | Recall initiated by company | |
| 22 Jan 2014 | Classified by FDA | +42 days |
| 29 Jan 2014 | 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
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Product as listed by the FDA
HydrOXYzine HCI Tablets USP 50 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-012-01, 500 count NDC: 10702-012-50, 1000 count NDC: 10702-012-10.
Where it was distributed
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Questions about this recall
Why was it recalled?
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Which lots are affected?
NDC 10702-012-01: lot # 10667, Jan-14; lot # 10677, exp. Jan-14; lot # 10679, exp. Jan-14; lot# 10688, exp. May-14; lot #10693, exp. Jul-14; lot #10854, Jul-14; lot # 10942, exp. Sep-14; lot #10995, exp.Oct-14; lot # 10996, Nov-14; lot #11138, exp. Feb-15; lot # 11139 Feb-15; lot # 11140, exp. Feb-15; lot # 11445, exp. Nov-15. NDC: 10702-012-10: lot # 10679, exp. Jan-14; lot # 10689, exp. Jun-14; lot # 10941, Sep-14; lot #10997; Nov-14; lot #10998, Nov-14; lot # 10999, Nov-14; lot #11445, exp. Nov-15. NDC: 10702-012-50: lot #10678, exp. Jan-14; lot #10689, exp. Jun-14; lot #10855, exp. Jul-14; lot # 10943, exp. Sep-14; lot # 11136, exp. Feb-15; lot #11137, exp. Feb-15; lot# 11445, exp. Nov-15.
Where was it sold?
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
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
2 other products · FDA event 67103This product is part of a recall event; the main page for the event is HydrOXYzine HCI Tablets USP 10 mg recalled by KVK-Tech.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | HydrOXYzine HCI Tablets USP 10 mg recalled by KVK-TechHydroxyzine Hydrochloride | Kvk-Tech | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | HydrOXYzine HCI Tablets USP 25 mg recalled by KVK-TechHydroxyzine Hydrochloride | Kvk-Tech | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Kvk-Tech
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Phentermine Hydrochloride Capsules, USP 30mg recalled by KVK TechPhentermine Hydrochloride | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Indomethacin Extended-Release Capsules USP, 75 mg recalled by KVK TechIndomethacin | KVK Tech | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Betaxolol Tablets, USP 10 mg recalled by KVK-TechBetaxolol Hydrochloride | Kvk-Tech | Other | Nationwide |
| Drug | CLASS I | Atovaquone Oral Suspension, USP, 750 mg recalled by KVK-TechAtovaquone Oral Suspension | Kvk-Tech | Temperature Abuse | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Homatropine Methlybromide recalledHydrocodone Bitartrate And Homatropine Methylbromide | Kvk-Tech | Potency & Assay | Nationwide |
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 |