Use caution Drug recall · FDA · Published July 23, 2012

American Health Packaging Recalls Mercaptopurine Tablets Due to Dissolution Failure

American Health Packaging recalls specific lots of Mercaptopurine Tablets, USP 50 mg because they failed USP dissolution test requirements. Check your lot number.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1668-2012Drug American Health Packaging ›

Use caution until it’s fixed

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.

Take action

Contact the company

Recalling firmAmerican Health Packaging2550 John Glenn Ave Ste A · Columbus, OH 43217-1188

✎ GovInfoNow plain-language explainer

American Health Packaging is recalling a specific lot of Mercaptopurine Tablets, USP 50 mg because the product failed USP dissolution test requirements. This means the medication may not dissolve properly in the body, potentially affecting its effectiveness. The recall was initiated in response to a similar recall by Prometheus Laboratories Inc. Read more at govinfonow.com/recall/48622-american-health-packaging-recalls-mercaptopurine-tablets-usp-50-mg-30.

Source Summary by GovInfoNow · govinfonow.com/recall/48622-american-health-packaging-recalls-mercaptopurine-tablets-usp-50-mg-30 · Updated October 13, 2026 · FDA enforcement record: FDA #D-1668-2012

Cite this page

“American Health Packaging Recalls Mercaptopurine Tablets Due to Dissolution Failure.” GovInfoNow, updated October 13, 2026. https://govinfonow.com/recall/48622-american-health-packaging-recalls-mercaptopurine-tablets-usp-50-mg-30. Based on FDA recall #D-1668-2012 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1668-2012%22&limit=1).

The FDA announced on July 23, 2012, that American Health Packaging is recalling Mercaptopurine Tablets, USP, 50 mg because they failed USP dissolution test requirements. The agency classified the recall as Class II.

How to tell if you have it

Brand: American Health Packaging
Product: Mercaptopurine Tablets, USP, 50 mg
Packaging: 30 Tablets (3 x 10) unit dose blisters per carton
UPC: 6808432511
NDC: 68084-325-21
Lot #: 120604
Expiration Date: 2/28/2013

The hazard

The recall addresses lots that do not meet the specification for dissolution, according to Prometheus Laboratories Inc. The FDA stated this is a sub-recall in response to that manufacturer's action.

Context

GovInfoNow's records show American Health Packaging has 41 other recalls on record since July 25, 2012. Recent brand recalls include a Buprenorphine Tablets recall for label mix-up hazards on August 19, 2026, and Nitrofurantoin Capsules recalled due to dissolution failure on May 3, 2022. Other recent recalls of similar products include Golden State Medical's Prasugrel HCl 10mg Tablets recall (August 21, 2026) and Inventia's Chlorthalidone recall for failed dissolution specs (September 3, 2026).

How to tell if you have this one

Check your medication package for the following details: Product is Mercaptopurine Tablets, USP, 50 mg, in 30-tablet unit dose blisters per carton. Packaged by American Health Packaging, Columbus, OH. The specific lot number is 120604 with an expiration date of 2/28/2013. The NDC is 68084-325-21 and the barcode is 6808432511.

Brand
American Health Packaging
Product
Mercaptopurine Tablets, USP, 50 mg, 30 Tablets (3 x 10) unit dose blisters per carton, Rx only, Packaged by American
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your Mercaptopurine Tablets match the recalled lot number 120604, expiration date 2/28/2013, and NDC 68084-325-21.
Contact Your Pharmacist
If you have the recalled product, contact your pharmacist or healthcare provider immediately to discuss replacement options.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “Nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

Jul 23, 2012Firm started the recall
Aug 29, 2012FDA classified it Class II
Sep 5, 2012Published in FDA’s Enforcement Report
Feb 19, 2013FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

✎ GovInfoNow

Questions people ask

From the GovInfoNow team · based on the FDA notice · How we make summaries

Who is distributing this specific batch?

The carton labeling indicates distribution by Par Pharmaceutical Companies, Inc., Spring Valley, NY 10977.

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Link to this recall

<a href="https://govinfonow.com/recall/48622-american-health-packaging-recalls-mercaptopurine-tablets-usp-50-mg-30">American Health Packaging Recalls Mercaptopurine Tablets Due to Dissolution Failure (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-1668-2012 (July 23, 2012) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1668-2012 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 13, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.