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Use caution Drug recall · FDA · Published December 18, 2015

Life-Line Docusate Calcium Recall: Label Mix-Up Hazard

National Vitamin Co recalls Life-Line Docusate Calcium stool softeners due to labeling errors. Check your bottle's UPC and lot number for details.

🇺🇸 FDA recall #D-0568-2016DrugLife-Line ›
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Recalling firmNational Vitamin Co Inc1145 W Gila Bend Hwy · Casa Grande, AZ 85122-4308
✎ GovInfoNow plain-language explainer

What happened, in plain English

National Vitamin Co Inc is recalling Life-Line Docusate Calcium Sodium Free Stool Softener because the label was mixed up. The product inside is actually Docusate Sodium 100mg Softgels, but it is labeled as Docusate Calcium 240mg. This means consumers may be taking a different medication or dosage than intended. Read more at govinfonow.com/recall/43321-life-line-docusate-calcium-recall-label-mix-up-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/43321-life-line-docusate-calcium-recall-label-mix-up-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-0568-2016

Cite this page

“Life-Line Docusate Calcium Recall: Label Mix-Up Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43321-life-line-docusate-calcium-recall-label-mix-up-hazard. Based on FDA recall #D-0568-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0568-2016%22&limit=1).

Why it’s dangerous

The hazard is a labeling error where Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg. Taking the wrong type or dosage of stool softener can lead to ineffective treatment or unexpected side effects, especially for those with specific dietary restrictions like sodium-free needs.

Who’s affected

Consumers who purchased Life-Line Docusate Calcium Sodium Free Stool Softener nationwide between the manufacturing date and the recall announcement are affected. Individuals relying on this specific calcium-based stool softener for medical reasons are most at risk of taking the wrong medication.

How to tell if you have this one

Look for bottles labeled 'Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle' with UPC 0-79854-95005-2. Check the NDC number 54629-0640-01 and Lot # 5EA46 with an expiration date of 02/17.

  • Brand
    Life-Line
  • Product
    Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Bottle

    Verify if your bottle matches the UPC 0-79854-95005-2, NDC 54629-0640-01, and Lot # 5EA46.

  2. Stop Using If Affected

    If your bottle matches the recalled lot, stop using it immediately to avoid taking the wrong medication.

  3. Contact Manufacturer

    Reach out to National Vitamin Co Inc for further instructions on disposal or 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 5 months after the firm started it.

1. Firm started the recall: Dec 18, 201512. FDA classified it Class III: Jan 12, 201623. Published in FDA’s Enforcement Report: Jan 20, 201634. FDA terminated the recall: May 3, 2016420152016
  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.

✎ GovInfoNow

Questions people ask

Who is selling this product?

The product was manufactured and distributed by National Vitamin Company in Casa Grande, AZ, and sold nationwide.

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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-0568-2016 (December 18, 2015) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0568-2016 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