Mercaptopurine Tablets recall
FDA recall D-0367-2024 · initiated Feb 9, 2024
Stason Pharmaceuticals, Inc. recalled Mercaptopurine Tablets in Feb 2024 — an FDA Class III recall (D-0367-2024) because Failed Dissolution Specifications: results slightly under spec at at 9-months.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Failed Dissolution Specifications: results slightly under spec at at 9-months.
Wrong strength, or it did not keep
The product did not contain what the label promised, or stopped meeting specification before its expiry date. Under-strength medicine can mean an untreated condition.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 54, 131 bottles
Details
- Product
- 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
- Recalling company
- Stason Pharms
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- USA Nationwide
- Initiated
- Feb 9, 2024
- FDA report date
- Mar 13, 2024
Frequently asked
- Was Mercaptopurine Tablets recalled?
- Stason Pharmaceuticals, Inc. recalled Mercaptopurine Tablets in Feb 2024 — an FDA Class III recall (D-0367-2024) because Failed Dissolution Specifications: results slightly under spec at at 9-months. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Mercaptopurine Tablets recalled?
- Per the FDA enforcement record, the reason for recall D-0367-2024 was: Failed Dissolution Specifications: results slightly under spec at at 9-months.
- Is a recalled Mercaptopurine Tablets dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Mercaptopurine Tablets are affected?
- Distributed: USA Nationwide. The recall covers these lots — 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.. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0367-2024.