CLASS II Drug recall · Reported 26 Dec 2018 · FDA Enforcement Report
Oxybutynin Chloride Tablets, USP, 5 mg recalled by KVK-Tech
KVK-Tech is recalling Oxybutynin Chloride Tablets, USP, 5 mg, distributed nationwide in the US. The recall was initiated on 11 Dec 2018 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-0340-2019
- FDA event ID
- 81804
- Recalling firm
- KVK-Tech, Newtown, PA
- Brand
- Oxybutynin Chloride
- Manufacturer
- KVK-Tech, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Dec 2018
- FDA classified
- 19 Dec 2018
- Reported
- 26 Dec 2018
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Bladder & Prostate Medication
Timeline
| 11 Dec 2018 | Recall initiated by company | |
| 19 Dec 2018 | Classified by FDA | +8 days |
| 26 Dec 2018 | 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
Labeling: Wrong bar code
Product as listed by the FDA
Oxybutynin Chloride Tablets, USP, 5 mg, 500-count bottle, Rx only, Mfd. By: KVK-Tech, Inc., Newtown, PA 18940, NDC 10702-201-50
Where it was distributed
Product was distributed by 10 major distributors throughout the United States.
Questions about this recall
Is Oxybutynin Chloride Tablets, USP, 5 mg recalled?
Yes. KVK-Tech recalled Oxybutynin Chloride Tablets, USP, 5 mg on 11 Dec 2018. The recall is Class II and its status is Terminated. Recall number D-0340-2019.
Why was it recalled?
Labeling: Wrong bar code
Which lots are affected?
Lot #: 15079A, Exp 10/20
Where was it sold?
Product was distributed by 10 major distributors throughout the United States.
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.
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 |
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| 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 Oxybutynin Chloride recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg recalledOxybutynin Chloride | Lannett Company | Potency & Assay | Nationwide |
| Drug | CLASS III | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) recalledOxybutynin Chloride | AVKARE | Potency & Assay | Nationwide |