CLASS II Food recall · Reported 20 Sep 2017 · FDA Enforcement Report

Leader Liquid Multivitamin Supplement for Infants and Toddlers recalled

The Harvard Drug Group is recalling Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1, distributed nationwide in the US. The recall was initiated on 2 Aug 2017 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLeader Liquid Multivitamin Supplement for Infants and Toddlers 1 2/3 oz (50 mL), UPC Number: 096295128611, All Unexpired Lots

Quantity recalled3,840 units

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

Recall details

Recall number: F-3530-2017
FDA event ID: 78007
Recalling firm: The Harvard Drug Group, Livonia, MI
Brand: Leader
Classification: Class II
Status: Terminated
Recall initiated: 2 Aug 2017
FDA classified: 12 Sep 2017
Reported: 20 Sep 2017
Type: Voluntary: Firm initiated
Customers notified by: Press Release
Reason category: Other Reasons
Product category: Vitamins

Timeline

2 Aug 2017	Recall initiated by company
12 Sep 2017	Classified by FDA	+41 days
20 Sep 2017	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are jointly initiating a voluntary recall of multiple supplements due to possible product contamination with B. cepacia, which may result in serious infections that could be life-threatening in patients with compromised immune systems and in patients with chronic lung conditions such as cystic fibrosis.

Product as listed by the FDA

Leader Liquid Multivitamin Supplement for Infants and Toddlers , 1 2/3 oz (50 mL)

Where it was distributed

Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305

Nationwide South Carolina Virginia

Questions about this recall

Why was it recalled?

Which lots are affected?

Leader Liquid Multivitamin Supplement for Infants and Toddlers 1 2/3 oz (50 mL), UPC Number: 096295128611, All Unexpired Lots

Where was it sold?

Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305

What should I do if I have it?

Do not eat it. Return it to the store for a refund or throw it away. If you have symptoms after eating it, contact a doctor.

What does Class II mean?

Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.

Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.

Other products in this recall event

16 other products · FDA event 78007

This product is part of a recall event; the main page for the event is Major Ferrous Drops recalled by The Harvard Drug Group.

Reported	Class	Recall	Company	Reason	Where
20 Sep 2017	CLASS II	Major Ferrous Drops recalled by The Harvard Drug GroupMajor Ferrous	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Major CertaVite Liquid recalled by The Harvard Drug GroupMajor CertaVite	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Tri-vitamin Liquid recalled by The Harvard Drug GroupRugby Tri-vitamin	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Major Poly-Vita Drops recalled by The Harvard Drug GroupMajor Poly-Vita	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Fer-iron Liquid recalled by The Harvard Drug GroupRugby Fer-iron	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Polyvitamin Liquid with Iron recalled by The Harvard Drug GroupRugby Polyvitamin	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Calcionate Syrup recalled by The Harvard Drug GroupRugby Calcionate	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Major Poly-Vita Drops with Iron recalled by The Harvard Drug GroupMajor Poly-Vita	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Leader Liquid Vitamin D Supplement for Breastfed Infants, 1 T oz recalledLeader	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Major D-Vita Drops recalled by The Harvard Drug GroupMajor	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Ferrous Sulfate Liquid recalled by The Harvard Drug GroupRugby Ferrous	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Liquid Vitamin C Supplement recalled by The Harvard Drug GroupRugby	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Cerovite Liquid recalled by The Harvard Drug GroupRugby Cerovite	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Major Tri-Vita Drops recalled by The Harvard Drug GroupMajor Tri-Vita	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby D 3 Vitamin Liquid, 400 IUI recalled by The Harvard Drug GroupRugby D	The Harvard Drug Group	Other	Nationwide
20 Sep 2017	CLASS II	Rugby Polyvitamin Liquid recalled by The Harvard Drug GroupRugby Polyvitamin	The Harvard Drug Group	Other	Nationwide

More recalls from The Harvard Drug Group

All 79

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11 Mar 2026Drug	CLASS II	Midodrine Hydrochloride Tablets, USP, 5 mg ( blister packs) recalledMidodrine Hydrochloride	The Harvard Drug Group	Packaging Defects	Nationwide
29 Oct 2025Drug	CLASS II	Gabapentin Capsules, USP, 100 mg ( blister packs) recalledGabapentin	The Harvard Drug Group	Potency & Assay	Nationwide

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