Skip to content
Use caution Drug recall · FDA · Published April 12, 2016

SKY Aspirin Recall: Label Mix-Up on Outer Carton

McKesson recalls SKY Aspirin Chewable Tablets due to a labeling error where the outer carton was incorrectly labeled. Check your lot number.

🇺🇸 FDA recall #D-0834-2016DrugSKY ›
Take action

Contact the company

Recalling firmMckesson Packaging Services7101 Weddington Rd NW · Concord, NC 28027-3412
✎ GovInfoNow plain-language explainer

What happened, in plain English

McKesson Packaging Services is recalling SKY Aspirin Chewable Tablets, 81 mg, because the outer carton was incorrectly labeled as aspirin chewable tablets when it likely contained something else. This labeling mix-up affects 1,676 boxes distributed nationwide. The record does not specify a remedy or what consumers should do with the product. Read more at govinfonow.com/recall/43005-sky-aspirin-recall-label-mix-up-on-outer-carton.

Source Summary by GovInfoNow · govinfonow.com/recall/43005-sky-aspirin-recall-label-mix-up-on-outer-carton · Updated October 11, 2026 · FDA enforcement record: FDA #D-0834-2016

Cite this page

“SKY Aspirin Recall: Label Mix-Up on Outer Carton.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43005-sky-aspirin-recall-label-mix-up-on-outer-carton. Based on FDA recall #D-0834-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0834-2016%22&limit=1).

Why it’s dangerous

The hazard is a labeling error where the outer carton incorrectly identifies the contents as aspirin chewable tablets. This could lead to accidental ingestion of an unintended medication if the user relies solely on the box label without checking the inner packaging or NDC code.

Who’s affected

Consumers who purchased SKY Aspirin Chewable Tablets, 81 mg, unit dose boxes from pharmacies or medical suppliers nationwide between the production date and April 12, 2016. Individuals relying on accurate medication labeling for their health are at risk of taking the wrong drug.

How to tell if you have this one

Look for SKY Aspirin Chewable Tablets, 81 mg, in a unit dose 750 tablets (25 x 30) box. The product is distributed by McKesson Packaging Service, Concord, NC 28027, with NDC 63739-434-01 and Lot number 0110701.

  • Brand
    SKY
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Medication

    Verify if you have SKY Aspirin Chewable Tablets, 81 mg, unit dose boxes with NDC 63739-434-01 and Lot 0110701.

  2. Contact McKesson

    Since the remedy is not stated in the record, contact McKesson Packaging Services for instructions on how to proceed with the recalled product.

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 11 months after the firm started it.

1. Firm started the recall: Apr 12, 201612. FDA classified it Class III: Apr 28, 201623. Published in FDA’s Enforcement Report: May 4, 201634. FDA terminated the recall: Mar 17, 2017420162017
  1. Firm started the recall
  2. FDA classified it Class III
  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.

Similar recalls

Latest drug recalls

Keep exploring

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-0834-2016 (April 12, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0834-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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