CLASS III Drug recall · Reported 13 Mar 2024 · FDA Enforcement Report
Mercaptopurine Tablets, USP 50 mg recalled by Stason Pharmaceuticals
Stason Pharmaceuticals is recalling Mercaptopurine Tablets, USP 50 mg, distributed nationwide in the US. The recall was initiated on 9 Feb 2024 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-0367-2024
- FDA event ID
- 93960
- Recalling firm
- Stason Pharmaceuticals, Irvine, CA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 9 Feb 2024
- FDA classified
- 6 Mar 2024
- Reported
- 13 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 9 Feb 2024 | Recall initiated by company | |
| 6 Mar 2024 | Classified by FDA | +26 days |
| 13 Mar 2024 | 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
Failed Dissolution Specifications: results slightly under spec at at 9-months.
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
Mercaptopurine Tablets, USP 50 mg, packaged in: a) 25-count bottle (NDC 69076-913-02), b) 250-count bottle (NDC 69076-913-25), Rx only, Manufactured for: Quinn Pharmaceuticals, Boca Raton, FL, www.quinnrx.com
Where it was distributed
USA Nationwide
Questions about this recall
Is Mercaptopurine Tablets, USP 50 mg recalled?
Yes. Stason Pharmaceuticals recalled Mercaptopurine Tablets, USP 50 mg on 9 Feb 2024. The recall is Class III and its status is Terminated. Recall number D-0367-2024.
Why was it recalled?
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Which lots are affected?
Lot #: a)22K012, 22K013A, Exp: 04/30/2024; 23A001, 23A002A, Exp: 07/31/2024; 23D006, 23D007A, 23D007C, Exp:10/31/2024; b)22K013B, Exp: 04/30/2024; 23A002B, Exp:07/31/2024; 23D007B, Exp: 10/31/2024.
Where was it sold?
USA 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 Stason Pharmaceuticals
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Selegiline HCL Tablets USP 5mg recalled by Stason Pharmaceuticals | Stason Pharmaceuticals | Potency & Assay | NC |
Other Mercaptopurine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mercaptopurine Tablets, USP, 50 mg dose blisters recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Mercaptopurine Tablets, USP 50mg, a) bottle recalled | Prometheus Laboratories | Potency & Assay | Nationwide |
| Drug | CLASS III | Mercaptopurine Tablets USP, 50 mg recalledMercaptopurine | Boehringer Ingelheim Roxane | Other | Nationwide |
| Drug | CLASS II | Mercaptopurine Tablets, USP, 50 mg dose blisters recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Mercaptopurine Tablets, USP, 50 mg recalled by Prometheus Laboratories | Prometheus Laboratories | Potency & Assay | Nationwide |