CLASS III Drug recall · Reported 20 Mar 2019 · FDA Enforcement Report
Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg recalled
Lannett is recalling Oxybutynin Chloride, Extended-Release Tablets USP, 10 mg, distributed nationwide in the US. The recall was initiated on 21 Feb 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-0996-2019
- FDA event ID
- 82144
- Recalling firm
- Lannett, Seymour, IN
- Brand
- Oxybutynin Chloride
- Manufacturer
- Lannett Company, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Feb 2019
- FDA classified
- 12 Mar 2019
- Reported
- 20 Mar 2019
- Type
- N/A
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Bladder & Prostate Medication
Timeline
| 21 Feb 2019 | Recall initiated by company | |
| 12 Mar 2019 | Classified by FDA | +19 days |
| 20 Mar 2019 | 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 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, 100 Tablet, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19154 NDC: 62175-271-37
Where it was distributed
Nationwide, including Puerto Rico.
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications
Which lots are affected?
Lots: 18226783A, exp 07/2021 and 18232540A, exp 08/2021
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 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 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.
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|---|---|---|---|---|---|
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Other Oxybutynin Chloride recalls
All 5| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) recalledOxybutynin Chloride | Avkare | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxybutynin Chloride Tablets, USP, 5 mg recalled by KVK-TechOxybutynin Chloride | Kvk-Tech | Other | Nationwide |
| Drug | CLASS II | Oxybutynin Chloride, Tablet, 2.5 mg (1/2 of 5 mg) recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Oxybutynin Chloride, Tablet, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |