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FDA Food Verify with FDA Food → Moderate Class II Terminated

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

Reported: September 20, 2017 Initiated: August 2, 2017 #F-3522-2017 117,098 units units

The Harvard Drug Group issued this FDA Food recall on September 20, 2017. Classified as Moderate severity (Class II). Approximately 117,098 units units are affected. The recall was issued because: The distribution firms Leader Brand, Major Pharmaceuticals, and The Harvard Drug Group dba Rugby Laboratories are joint…. This recall notice is sourced from official FDA Food enforcement records. Below you will find the complete product description, hazard information, remedy instructions, and related recalls from the same manufacturer or product category.

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 indicate 117,098 units units are affected, 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.

To put this record in context, PlainRecalls indexes 83,949 recalls across the FDA, CPSC, NHTSA and USDA FSIS going back to 1995. Within the same product category, the database holds 6 closely related recalls. That clustering is a signal — repeated actions in a narrow category often indicate a systemic quality-control issue, a supplier-wide contamination, or a design defect that has propagated across product lines. This recall is roughly 9 years old; older recalls can remain relevant because many units enter resale, rental, and secondary-market channels where the original warning never reaches the end user. Always cross-check the recall number against the official agency page before relying on any summary.

Recall Distribution by Severity Class

Severity1Class I (Critical)Class II (Moderate)Class III (Low)
Recall Distribution by Severity Class

Severity

Moderate

Units Affected

117,098 units

Related Recalls

6

0 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.

Details

Recalling Firm
The Harvard Drug Group
Units Affected
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
Location
Livonia, MI

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
Units affected 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.

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.

Recall Context

Product recalls are issued when a manufacturer, distributor, or federal agency determines that a product poses a safety risk to consumers. This recall is classified as moderate severity, indicating the product may cause temporary or medically reversible health consequences. Across PlainRecalls, we track 83,000+ recalls from FDA, CPSC, and NHTSA to help consumers stay informed and act quickly when safety issues arise.

Nearby Recalls in This Category

Other recalls in the same product category — useful for spotting patterns across the same defect class or manufacturer.

Compare this recall with Icosapent Ethyl Capsules, 1 gram, 120 Capsules per bottle, … →

Data Sources

Data as of 2025. Source: FDA, CPSC, NHTSA, USDA FSIS federal recall databases.

  • Source: FDA — Food and Drug Administration, openFDA Enforcement API (food, drug, and medical device recalls)
  • Source: CPSC — Consumer Product Safety Commission Recalls API (consumer product recalls and hazards)
  • Source: NHTSA — National Highway Traffic Safety Administration Recalls API (vehicle safety recalls)
  • Source: USDA FSIS — Food Safety and Inspection Service (meat, poultry, and egg product recalls)

Recall information is sourced from official federal agency databases. Always verify recall details with the issuing agency for the most current status. This information is for research and awareness purposes only.

All federal data sources used on this page

Source: Federal recall agencies (FDA, CPSC, NHTSA, USDA FSIS) Aggregated multi-agency recall feeds · 2024 Recall data normalized across federal agency feeds; severity classifications follow each agency's own taxonomy (FDA Class I/II/III; CPSC, NHTSA, USDA FSIS).