CLASS II Drug recall · Reported 26 Nov 2014 · FDA Enforcement Report
Mercaptopurine Tablets, USP 50mg, a) bottle recalled
Prometheus Laboratories is recalling Mercaptopurine Tablets, USP 50mg, a) bottle (, distributed nationwide in the US. The recall was initiated on 22 Oct 2014 and the FDA has classified it as Class II.
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-0249-2015
- FDA event ID
- 69572
- Recalling firm
- Prometheus Laboratories, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 22 Oct 2014
- FDA classified
- 14 Nov 2014
- Reported
- 26 Nov 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 22 Oct 2014 | Recall initiated by company | |
| 14 Nov 2014 | Classified by FDA | +23 days |
| 26 Nov 2014 | 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
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
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 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Dissolution Specifications: Product found to be out of specification (OOS) during stability testing.
Which lots are affected?
Mercaptopurine Tablets, USP 50mg, a) 60-count bottle (NDC 49884-922-02), b) 250-count bottle (NDC 49884-922-04), RX only, Manufactured by Stason Pharmaceuticals, Inc., 11 Morgan, Irvine, CA 92618 for Prometheus Laboratories, Inc., 9410 Carroll Park Drive, San Diego, CA 92121 Lot #: a) 140B11, Exp Feb 2016; 14B012, Exp Feb 2016; 14B013, Exp Feb 2016 Lot #: b) 13F046, Exp Jun 2015; 13K073, Exp Oct 2015; 13L075, Exp Oct 2015; 14B010, Exp Feb 2016.
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
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 Prometheus Laboratories
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Mercaptopurine Tablets, USP, 50 mg recalled by Prometheus Laboratories | Prometheus Laboratories | Potency & Assay | Nationwide |
Other Mercaptopurine recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Mercaptopurine Tablets, USP 50 mg recalled by Stason Pharmaceuticals | Stason Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Mercaptopurine Tablets, USP, 50 mg dose blisters recalled | American Health Packaging | 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 |