CLASS II Drug recall · Reported 29 Aug 2012 · FDA Enforcement Report
Mercaptopurine Tablets, USP, 50 mg recalled by Prometheus Laboratories
Prometheus Laboratories is recalling Mercaptopurine Tablets, USP, 50 mg, distributed nationwide in the US. The recall was initiated on 29 Jun 2012 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-1659-2012
- FDA event ID
- 62772
- Recalling firm
- Prometheus Laboratories, San Diego, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 29 Jun 2012
- FDA classified
- 22 Aug 2012
- Reported
- 29 Aug 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 29 Jun 2012 | Recall initiated by company | |
| 22 Aug 2012 | Classified by FDA | +54 days |
| 29 Aug 2012 | 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 USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
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) 60-count tablets per bottle (NDC 49884-922-02) and b) 250-count tablets per bottle (NDC 49884-922-04), Rx only, Distributed by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.
Where it was distributed
Nationwide and Puerto Rico.
Questions about this recall
Why was it recalled?
Failed USP Dissolution Test Requirements: The recalled lots do not meet the specification for dissolution.
Which lots are affected?
Lot #s: a) 11A003, 11A004, 11A005, Exp 01/13; 11L071, 11L072, Exp 10/13; b) 11B009, Exp 01/13; 11L073, Exp 10/13
Where was it sold?
Nationwide and 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 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 50mg, a) bottle recalled | 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 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 |