CLASS II Drug recall · Reported 5 Sep 2012 · 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 23 Jul 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-1668-2012
- FDA event ID
- 62748
- Recalling firm
- American Health Packaging, Columbus, OH
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 23 Jul 2012
- FDA classified
- 29 Aug 2012
- Reported
- 5 Sep 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 23 Jul 2012 | Recall initiated by company | |
| 29 Aug 2012 | Classified by FDA | +37 days |
| 5 Sep 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: 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, Packaged by American Health Packaging, 2550-A John Glenn Avenue, Columbus, OH 43217, barcode 6808432511; Carton labeling Dist by: Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977, 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 #: 120604 Exp 2/28/2013
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 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Metoclopramide Tablets, USP, 5 mg (10 recalledMetoclopramide | American Health Packaging | Packaging Defects | Nationwide |
| 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 |
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 recalled by Prometheus Laboratories | Prometheus Laboratories | Potency & Assay | Nationwide |