Severity
Moderate
ModerateClass IITerminated
FDA Food recall · Reported September 20, 2017
Major Tri-Vita Drops, 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…
Compiled from official public sources by the editorial team.
Verify with FDA Food →
The Harvard Drug Group recalled Major Tri-Vita Drops, 1 2/3 oz (50 mL) - a moderate-severity action.
Major Tri-Vita Drops, 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-3529-2017 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
- 10K units
- affected scope
- Class II
- classification
- September 20, 2017
- reported
Sourced from official FDA Food enforcement records. Verify recall #F-3529-2017 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Food action (record #F-3529-2017) 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 10,074 units.
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 — 14,048 drugs & medications recalls on record
Where this recall sits in the database
Of 100,165 recalls in the database, 23,668 are high severity, 72,097 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.
Affected scope
10,074 units
Related Recalls
6
1 from same agency
Product description
Major Tri-Vita Drops, 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
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | F-3529-2017 |
| Date reported | September 20, 2017 |
| Date initiated | August 2, 2017 |
| Recalling firm | The Harvard Drug Group |
| Firm location | Livonia, MI |
| Affected scope | 10,074 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.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (F-3529-2017) 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? ▼
Major Tri-Vita Drops, 1 2/3 oz (50 mL). Recalled by The Harvard Drug Group. Units affected: 10,074 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-3529-2017.
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-3529-2017) 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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Data Sources
Source: FDA, CPSC, and NHTSA federal recall databases. This recall: FDA Food, reported September 20, 2017.
- 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)
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.
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. 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 June 2026.