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Stop using now Food recall · FDA · Published August 2, 2017

Major Ferrous Drops Recall: B. cepacia Contamination Risk

The Harvard Drug Group recalls Major Ferrous Drops due to possible B. cepacia contamination, which may cause serious infections in vulnerable patients.

🇺🇸 FDA recall #F-3526-2017FoodMajor ›
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Recalling firmThe Harvard Drug Group17177 N Laurel Park Dr Ste 233 · Livonia, MI 48152-3951
✎ GovInfoNow plain-language explainer

What happened, in plain English

The Harvard Drug Group is voluntarily recalling Major Ferrous Drops (1 2/3 oz / 50 mL) because the product may be contaminated with B. cepacia bacteria. This contamination poses a risk of serious, potentially life-threatening infections for individuals with compromised immune systems or chronic lung conditions like cystic fibrosis. The recall covers all unexpired lots of this specific product size. Read more at govinfonow.com/recall/20596-major-ferrous-drops-recall-b-cepacia-contamination-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/20596-major-ferrous-drops-recall-b-cepacia-contamination-risk · Updated October 11, 2026 · FDA enforcement record: FDA #F-3526-2017

Cite this page

“Major Ferrous Drops Recall: B. cepacia Contamination Risk.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/20596-major-ferrous-drops-recall-b-cepacia-contamination-risk. Based on FDA recall #F-3526-2017 (https://api.fda.gov/food/enforcement.json?search=recall_number:%22F-3526-2017%22&limit=1).

Why it’s dangerous

The product may contain B. cepacia, a bacterium that can cause severe infections. For healthy individuals, this might be less concerning, but for those with weakened immune systems or chronic lung diseases like cystic fibrosis, these infections can be life-threatening.

Who’s affected

Consumers who purchased Major Ferrous Drops, 1 2/3 oz (50 mL), with UPC Number 3 09046 27350 9. Individuals with compromised immune systems or chronic lung conditions such as cystic fibrosis are at the highest risk for serious infection.

How to tell if you have this one

Check your bottle to see if it is Major Ferrous Drops in the 1 2/3 oz (50 mL) size. Verify the UPC Number is 3 09046 27350 9 and ensure the product is from an unexpired lot. The product was distributed nationwide to USA consumers.

  • Brand
    Major
  • Category
    Food
FDA recall event · 17 products

All 17 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305
Recall numberProduct, codes & lotsQuantity
F-3515-2017Rugby Calcionate Syrup, One Pint (473 mL); UPC Number: 0 05362 77085 1, All Unexpired Lots5,771 units
F-3516-2017Rugby Cerovite Liquid, 8 oz. 236ML; Rugby Cerovite Liquid, 236ML, UPC Number: 00536-2790-59, All Unexpired Lots65,611 units
F-3517-2017Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, 1 and 2/3 oz., 50 mL; Rugby D 3 Vitamin Liquid, 400 IUI/1 mL, UPC Number: 0 05368 40080 6, All Unexpired Lots105,628 units
F-3518-2017Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL; Rugby Fer-iron Liquid, 1 and 2/3 oz., 50 mL, UPC Number: 00536-0710-80, All Unexpired Lots27,011 units
F-3519-2017Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL; Rugby Liquid Vitamin C Supplement, 4 oz., 118 mL, UPC Number: 0 05360 16097 0, All Unexpired Lots30,782 units
F-3520-2017Rugby Ferrous Sulfate Liquid One Pint, (473 mL); Rugby Ferrous Sulfate Liquid,One Pint (473 mL), UPC Number:0 05360 65085 8, All Unexpired Lots34,280 units
F-3521-2017Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL); Rugby Polyvitamin Liquid, 1 2/3 oz (50 mL), UPC Number:0 05368 45080 1, All Unexpired Lots113,829 units
F-3522-2017Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL); Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL), UPC Number: 0 05368 53080 0, All Unexpired Lots117,098 units
F-3523-2017Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL); Rugby Tri-vitamin Liquid, 1 2/3 oz (50 mL), UPC Number:0 05368 50180 0, All Unexpired Lots52,897 units
F-3524-2017Major CertaVite Liquid, 8 oz. (236 mL); Major CertaVite Liquid, 8 oz. (236 mL), UPC Number:3 09045 02309 9, All Unexpired Lots61,262 units
F-3525-2017Major D-Vita Drops, 1 2/3 oz (50 mL); Major D-Vita Drops,1 2/3 oz (50 mL), UPC Number:3 09046 27350 9, All Unexpired Lots27,447 units
F-3526-2017Major Ferrous Drops, 1 2/3 oz (50 mL); Major Ferrous Drops,1 2/3 oz (50 mL), UPC Number:3 09046 27350 9, All Unexpired Lots63,005 units
F-3527-2017Major Poly-Vita Drops, 1 2/3 oz (50 mL); Major Poly-Vita Drops,1 2/3 oz (50 mL), UPC Number:3 09045 09950 6, All Unexpired Lots27,735 units
F-3528-2017Major Poly-Vita Drops with Iron, 1 2/3 oz (50 mL); Major Poly-Vita Drops with Iron,1 2/3 oz (50 mL), UPC Number:3 09045 10050 9, All Unexpired Lots33,390 units
F-3529-2017Major Tri-Vita Drops, 1 2/3 oz (50 mL); Major Tri-Vita Drops,1 2/3 oz (50 mL), UPC Number: 3 09046 27450 6, All Unexpired Lots10,074 units
F-3530-2017Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL); Leader Liquid Multivitamin Supplement for Infants and Toddlers 1 2/3 oz (50 mL), UPC Number: 096295128611, All Unexpired Lots3,840 units
F-3531-2017Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL); Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz (50 mL), UPC Number: 0 96295 12862 8, All Unexpired Lots1,728 units
Based on the official FDA remedy

What to do — step by step

  1. Stop using the product

    Discontinue use of Major Ferrous Drops immediately if you have the recalled 1 2/3 oz (50 mL) bottles with UPC Number 3 09046 27350 9.

  2. Contact the manufacturer

    Reach out to The Harvard Drug Group for further instructions on disposal or return, as specific remedy details are not provided in this record.

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: “Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Aug 2, 201712. FDA classified it Class II: Sep 12, 201723. Published in FDA’s Enforcement Report: Sep 20, 201734. FDA terminated the recall: Apr 28, 2020420172020
  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.

✎ GovInfoNow

Questions people ask

How was the product distributed?

The product was distributed nationwide to consumers in the USA, as well as to VA CMOP Charleston in South Carolina.

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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 #F-3526-2017 (August 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for F-3526-2017 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