CLASS III Drug recall · Reported 20 Mar 2019 · FDA Enforcement Report
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) recalled
AVKARE is recalling Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) (, distributed nationwide in the US. The recall was initiated on 1 Mar 2019 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-0990-2019
- FDA event ID
- 82296
- Recalling firm
- AVKARE, Pulaski, TN
- Brand
- Oxybutynin Chloride
- Manufacturer
- AvKARE
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Mar 2019
- FDA classified
- 11 Mar 2019
- Reported
- 20 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Bladder & Prostate Medication
Timeline
| 1 Mar 2019 | Recall initiated by company | |
| 11 Mar 2019 | Classified by FDA | +10 days |
| 20 Mar 2019 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Dissolution 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
Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 42291-634-01) and b) 500 tablets (NDC 42291-634-50) bottles, Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478
Where it was distributed
Nationwide.
Questions about this recall
Is Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) ( recalled?
Yes. AVKARE recalled Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) ( on 1 Mar 2019. The recall is Class III and its status is Terminated. Recall number D-0990-2019.
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lots: a) 22738 Exp. 07/2020 and b) 22739 Exp. 07/2020
Where was it sold?
Nationwide.
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 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 AVKARE
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|---|---|---|---|---|---|
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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 II | Oxybutynin Chloride Tablets, USP, 5 mg recalled by KVK-TechOxybutynin Chloride | KVK-Tech | Other | Nationwide |