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Use caution Drug recall · FDA · Published November 19, 2014

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 numbers.

🇺🇸 FDA recall #D-0300-2015DrugAmerican Health Packaging ›
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Recalling firmAmerican Health Packaging2550 John Glenn Ave, Suite A · Columbus, OH 43217-1188
✎ GovInfoNow plain-language explainer

American Health Packaging is recalling Mercaptopurine Tablets, USP, 50 mg because the medication does not meet the required specifications for dissolution. This issue stems from a recall by the manufacturer, Prometheus Laboratories Inc. The tablets may not release the drug properly in the body, potentially affecting treatment efficacy. Read more at govinfonow.com/recall/45147-american-health-packaging-recalls-mercaptopurine-tablets-usp-50-mg-30.

Source Summary by GovInfoNow · govinfonow.com/recall/45147-american-health-packaging-recalls-mercaptopurine-tablets-usp-50-mg-30 · Updated October 12, 2026 · FDA enforcement record: FDA #D-0300-2015

Cite this page

“American Health Packaging Recalls Mercaptopurine Tablets Due to Dissolution Failure.” GovInfoNow, updated October 12, 2026. https://govinfonow.com/recall/45147-american-health-packaging-recalls-mercaptopurine-tablets-usp-50-mg-30. Based on FDA recall #D-0300-2015 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0300-2015%22&limit=1).

The FDA announced on 2014-11-19 that American Health Packaging is recalling Mercaptopurine Tablets, USP, 50 mg because the lots failed USP dissolution test requirements. Owners should contact the manufacturer for a refund. GovInfoNow's records show this Class II recall involved 3,496 cartons distributed nationwide.

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
  • NDC: 68084-325-21
  • Lot #: 142450 Exp 05/2015
  • Lot #: 140862 Exp 02/2015
  • Lot #: 141596 Exp 03/2015
  • Lot #: 134770 Exp 01/2015

The hazard

The recall is due to the lots not meeting the specification for dissolution, according to the FDA. This sub-recall was initiated in response to a Prometheus Laboratories Inc. recall for Mercaptopurine USP 50mg.

Context

GovInfoNow's records show American Health Packaging has 41 other recalls on record since 2012-07-23. Other recent recalls of similar products include American Health Packaging Buprenorphine Tablets Recall (2026-08-19), American Health Packaging Nitrofurantoin Capsules Recall (2022-05-03), and American Health Packaging Recalls Cyanocobalamin Injection Due to Subpotent Drug (2022-04-12). Other recent recalls of similar products include Golden State Medical Recalls Prasugrel HCl 10mg Tablets (2026-08-21), Inventia Chlorthalidone Recall (2026-09-03), and Teva Recalls Metoprolol Succinate 50 mg Due to Dissolution Failure (2026-01-29).

How to tell if you have this one

Check your bottle for NDC 68084-325-21. Look for Lot numbers 142450 (Exp 05/2015), 140862 (Exp 02/2015), 141596 (Exp 03/2015), or 134770 (Exp 01/2015). The product is packaged as 30 Tablets in unit dose blisters per carton.

  • Brand
    American Health Packaging
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if your Mercaptopurine tablets match the NDC and lot numbers listed above.

  2. Contact Your Pharmacist

    If you have one of the recalled lots, speak with your pharmacist or healthcare provider about obtaining a replacement.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

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 6 months after the firm started it.

1. Firm started the recall: Nov 19, 201412. FDA classified it Class II: Dec 16, 201423. Published in FDA’s Enforcement Report: Dec 24, 201434. FDA terminated the recall: Jun 1, 2015420142015
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

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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-0300-2015 (November 19, 2014) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0300-2015 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 12, 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA