CLASS III Drug recall · Reported 14 Sep 2016 · FDA Enforcement Report
Selegiline HCL Tablets USP 5mg recalled by Stason Pharmaceuticals
Stason Pharmaceuticals is recalling Selegiline HCL Tablets USP 5mg, distributed in North Carolina. The recall was initiated on 23 Aug 2016 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-1479-2016
- FDA event ID
- 75025
- Recalling firm
- Stason Pharmaceuticals, Irvine, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 23 Aug 2016
- FDA classified
- 2 Sep 2016
- Reported
- 14 Sep 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 23 Aug 2016 | Recall initiated by company | |
| 2 Sep 2016 | Classified by FDA | +10 days |
| 14 Sep 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
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
Selegiline HCL Tablets USP 5mg, 60- count bottles, Rx only, Manufactured by: Stason Pharmaceuticals, Inc. Irvine, CA 92618 Distributed by: Libertas Pharma, Inc. Montgomery, AL 36117. NDC 51862-146-06
Where it was distributed
North Carolina
Questions about this recall
Why was it recalled?
Stason Pharmaceuticals is recalling Selegiline HCl tablets, USP 5mg 60 count bottle due to an out of specification result for dissolution of stability samples.
Which lots are affected?
Lot #: 14F030, 14F031, 14F032, Exp. June 2017; 15G022, Exp. July 2018
Where was it sold?
North Carolina
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.
More recalls from Stason Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mercaptopurine Tablets, USP 50 mg recalled by Stason Pharmaceuticals | Stason Pharmaceuticals | Potency & Assay | Nationwide |
Other Selegiline recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Selegiline HCL, Capsule, 5 mg recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |