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CriticalClass ITerminated

FDA Drug recall · Reported November 6, 2019

Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

Recall #
D-0320-2020
Affected scope
9000 bottles
Initiated
September 16, 2019
Verify with FDA Drug →
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Fitoterapia USA, INC recalled Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (6… - a critical-severity action.

Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (6… was recalled by Fitoterapia USA, INC in November 6, 2019. Reason: Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.. Check the official notice for the remedy. Verify recall #D-0320-2020 with the FDA Drug before acting.

The recall

Fitoterapia USA, INC issued this critical-severity FDA Drug recall-Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil..

Critical
severity level
Class I
classification
November 6, 2019
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0320-2020 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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 - 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.

Food recalls over time

Where this recall sits in its category - 25,457 food recalls on record

01,0002,0003,000 20052008201120142017202020232026 813
Severity1906864652High severity (most serious)Moderate severityLow severity
Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. This recall is classified high severity.

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

Product description

Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028

Reason for recall

Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Critical (Class I)
Status Terminated
Recall number D-0320-2020
Date reported November 6, 2019
Date initiated September 16, 2019
Recalling firm Fitoterapia USA, INC
Firm location Pembroke Pines, FL
Affected scope 9000 bottles
Distribution FL, PA, NY and Canada

Profile values are sourced directly from the official FDA Drug 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 (D-0320-2020) and product description against the item you own. Search the archive
  • Confirm the current status with FDA Drug before acting, recall details can be updated.
  • This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next

This page summarizes the official FDA Drug 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?
Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2.04 fl oz (60 mL) bottle, Manufactured By: Zaphiredelcor Cia, LTDA. Pasaje Luis Tola 9A Y Calle Juan Campuzano, Sector Carcelen, Quito-Ecuador 170302 Distributed By: Fitoterapia USA Inc., 500 NW 141 Ave. 112 Pembroke Pines, FL 33028. Recalled by Fitoterapia USA, INC. Units affected: 9000 bottles.
Why was this product recalled?
Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil.
Which agency issued this recall?
This recall was issued by the FDA Drug on November 6, 2019. Severity: Critical. Recall number: D-0320-2020.
Where was the recalled product distributed?
Distribution: FL, PA, NY and Canada.
Should I stop using a recalled medication or medical device?
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Compare this recall with Grade A White In-shell Chicken eggs packaged in the followi… → · All Food recalls

This recall: FDA Drug, reported November 6, 2019. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026