CLASS II Drug recall · Reported 29 Jan 2014 · FDA Enforcement Report
HydrOXYzine HCI Tablets USP 25 mg recalled by KVK-Tech
KVK-Tech is recalling HydrOXYzine HCI Tablets USP 25 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-1031-2014
- 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 25 mg, 100, 500, and 1000 count bottles, Rx only. Mfd by: KVK-TECH, INC, Newtown, PA 18940. 100 count NDC: 10702-011-01, 500 count NDC: 10702-011-50, 1000 count NDC: 10702-011-10.
Where it was distributed
Nationwide, including Puerto Rico to wholesale distributors for sale to retail establishments.
Questions about this recall
Is HydrOXYzine HCI Tablets USP 25 mg, 100, 500 recalled?
Yes. KVK-Tech recalled HydrOXYzine HCI Tablets USP 25 mg, 100, 500 on 11 Dec 2013. The recall is Class II and its status is Terminated. Recall number D-1031-2014.
Why was it recalled?
Good Manufacturing Practices Deviations: The product has an Active Pharmaceutical Ingredient from an unapproved source.
Which lots are affected?
NDC: 10702-011-01: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp.May-14; lot #10790, exp. Jun-14; lot # 10791, exp. Jun-14: lot # 10792, exp. Aug-14; lot #10983, exp. Sep-14; lot #10984, exp.Sep-14; lot #10986, exp. Oct-14; lot # 11034, exp. Nov-14; lot #11035, exp. Dec-14; lot # 11036, exp. Dec-14; lot #11435, exp. Nov-15. NDC: 10702-011-10: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot #10789, exp. May-14; lot #10790, exp. Jun-14; lot #10791, exp. Jun-14; lot #10792, exp. Aug-14; lot # 10983, exp. Sep-14; lot #10985, exp. Oct-14; lot #11034, exp. Nov-14; lot #11038, exp. Dec-14; lot #11435, exp. Nov-15. NDC: 10702-011-50: lot #10666, exp. Feb-14; lot #10733, exp. May-14; lot # 10789, exp. May-14; lot #10791, exp. Jun-14; lot# 10792, exp. Aug-14; lot # 10983, exp. Sep-14; lot # 10985, exp. Oct-14; lot # 10986, exp. Oct-14; lot # 11037, exp. Dec-14; lot #11435, 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 21 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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