PlainRecalls
ModerateClass IITerminated

FDA Food recall · Reported September 20, 2017

Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)

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…

Recall #
F-3522-2017
Affected scope
117,098 units
Initiated
August 2, 2017
Compiled from official public sources by the editorial team.
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The Harvard Drug Group recalled Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL) - a moderate-severity action.

Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL) was recalled by The Harvard Drug Group in September 20, 2017. Reason: The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories…. Check the official notice for the remedy. Verify recall #F-3522-2017 with the FDA Food before acting.

The recall

The Harvard Drug Group issued this moderate-severity FDA Food recall-The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories….

Moderate
severity level
117K units
affected scope
Class II
classification
September 20, 2017
reported

Sourced from official FDA Food enforcement records. Verify recall #F-3522-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This FDA Food action (record #F-3522-2017) was formally reported on September 20, 2017, with the manufacturer initiating the action on August 2, 2017. It is classified under Moderate severity (Class II), with a current status of Terminated. The Harvard Drug Group is listed as the recalling firm, operating out of Livonia, MI. Federal records list the affected scope as 117,098 units, a scale large enough to require multi-state distribution tracking.

The documented reason for this recall is: 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 … Distribution data in the federal record shows the product reached: Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.

Within the same product category the archive holds 6 closely related recalls, 1 from FDA Food - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.

Drugs & Medications recalls over time

Where this recall sits in its category - 14,287 drugs & medications recalls on record

-50005001,0001,5002,000 2006201220152018202120242026 263
Severity2487872426High severity (most serious)Moderate severityLow severity
Where this recall sits in the database

Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified moderate severity.

Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.

Severity

Moderate

Affected scope

117,098 units

Related Recalls

6

1 from same agency

Product description

Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL)

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.

Recall Profile

Structured summary of the FDA Food recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number F-3522-2017
Date reported September 20, 2017
Date initiated August 2, 2017
Recalling firm The Harvard Drug Group
Firm location Livonia, MI
Affected scope 117,098 units
Distribution Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305

Profile values are sourced directly from the official FDA Food enforcement record. Source: U.S. Food and Drug Administration.

Scale of Impact

117,098 units units affected - multi-state distribution scale.

Regional (<10K units) -
Multi-state (10K – 100K units) -
Large-scale (100K – 1M units) ✓ This recall
Massive (≥1M units) -

Bracket cutoffs follow federal recall-disclosure conventions; bar widths scale linearly within each bracket. Source: PlainRecalls analysis of U.S. Food and Drug Administration filings.

What to do with this recall

Match your product against the recall record, then act on the agency remedy.

  • Check the recall number (F-3522-2017) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Food before acting, recall details can be updated.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next

This page summarizes the official FDA Food record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.

Frequently Asked Questions

What product was recalled?
Rugby Polyvitamin Liquid with Iron, 1 2/3 oz (50 mL). Recalled by The Harvard Drug Group. Units affected: 117,098 units.
Why was this product recalled?
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.
Which agency issued this recall?
This recall was issued by the FDA Food on September 20, 2017. Severity: Moderate. Recall number: F-3522-2017.
Where was the recalled product distributed?
Distribution: Domestic: Nationwide to USA Foreign: None VA/DOD: VA CMOP CHARLESTON 3725 RIVERS AVE N. CHARLESTON SC 29405-7038, Ph. 303-339-4305.
How do I check if my product is affected by a recall?
Check the product description and recall number (F-3522-2017) against your product. Visit the official FDA Food website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
What are the health risks of consuming a recalled food product?
Recalled food products may contain contaminants, undeclared allergens, or harmful bacteria such as Salmonella, Listeria, or E. coli. Consuming these products can cause foodborne illness ranging from mild gastrointestinal symptoms to serious conditions requiring hospitalization. If you have consumed a recalled food product and experience symptoms, contact your healthcare provider and report to the FDA via MedWatch.

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Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Food, reported September 20, 2017. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.