CLASS II Drug recall · Reported 24 Dec 2014 · FDA Enforcement Report
Mercaptopurine Tablets, USP, 50 mg dose blisters recalled
American Health Packaging is recalling Mercaptopurine Tablets, USP, 50 mg dose blisters per, distributed nationwide in the US. The recall was initiated on 19 Nov 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-0300-2015
- FDA event ID
- 69972
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Nov 2014
- FDA classified
- 16 Dec 2014
- Reported
- 24 Dec 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 19 Nov 2014 | Recall initiated by company | |
| 16 Dec 2014 | Classified by FDA | +27 days |
| 24 Dec 2014 | Published in enforcement report | +8 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: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does 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, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Manufactured by Prometheus Laboratories Inc. 9410 Carroll Park Drive, San Diego, CA 92121, repackaged by American Health Packaging 2550-A John Glenn Avenue, Columbus, OH 43217, NDC 68084-325-21
Where it was distributed
Nationwide.
Questions about this recall
Why was it recalled?
Failed USP Dissolution Test Requirements: This sub-recall is in response to Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg because the lot does not meet the specification for dissolution.
Which lots are affected?
Lot #: 142450 Exp 05/2015; 140862 Exp 02/2015; 141596 Exp 03/2015; 134770 Exp 01/2015
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 American Health Packaging
All 60| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Buprenorphine Sublingual Tablets (C-iii), 2 mg recalledBuprenorphine | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS III | Nitrofurantoin Capsules, USP (Monohydrate/Macrocrystals) recalled | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS III | Cyanocobalamin Injection, USP, 1000 mcg per mL recalled | American Health Packaging | Potency & Assay | AL |
| Drug | CLASS II | Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg recalledOxycodone Hydrochloride | American Health Packaging | Potency & Assay | Nationwide |
| Drug | CLASS II | Metoprolol Succinate Extended-Release Tablets, USP 50 mg recalledMetoprolol Succinate | American Health Packaging | 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 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 |