PlainRecalls
ModerateClass IITerminated

FDA Drug recall · Reported February 19, 2020

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

Microbial Contamination of Non-Sterile Products

Recall #
D-0845-2020
Affected scope
5249 6 Fl Oz bottles
Initiated
January 31, 2020
Verify with FDA Drug →
View my saved recalls

Efficient Laboratories, Inc. recalled Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient… - a moderate-severity action.

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient… was recalled by Efficient Laboratories, Inc. in February 19, 2020. Reason: Microbial Contamination of Non-Sterile Products. Check the official notice for the remedy. Verify recall #D-0845-2020 with the FDA Drug before acting.

The recall

Efficient Laboratories, Inc. issued this moderate-severity FDA Drug recall-Microbial Contamination of Non-Sterile Products.

Moderate
severity level
Class II
classification
February 19, 2020
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0845-2020 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, 1 from FDA Drug - 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.

Children & Baby Products recalls over time

Where this recall sits in its category - 3,781 children & baby products recalls on record

0100200300400500600 20052008201120142017202020232026 196
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 moderate severity.

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

Product description

Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8

Reason for recall

Microbial Contamination of Non-Sterile Products

Recall Profile

Structured summary of the FDA Drug recall record
Attribute Value
Agency U.S. Food and Drug Administration
Severity class Moderate (Class II)
Status Terminated
Recall number D-0845-2020
Date reported February 19, 2020
Date initiated January 31, 2020
Recalling firm Efficient Laboratories, Inc.
Firm location Miami, FL
Affected scope 5249 6 Fl Oz bottles
Distribution Distributed Nationwide in the USA

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-0845-2020) 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.
  • Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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?
Rompe Pecho CF Cold & Flu with Honey, 6 FL. Oz (178 mL) bottle, Distributed by: Efficient Laboratories, Inc. Miami, FL 33166.UPC 0 00856 33106 8. Recalled by Efficient Laboratories, Inc.. Units affected: 5249 6 Fl Oz bottles.
Why was this product recalled?
Microbial Contamination of Non-Sterile Products
Which agency issued this recall?
This recall was issued by the FDA Drug on February 19, 2020. Severity: Moderate. Recall number: D-0845-2020.
Where was the recalled product distributed?
Distribution: Distributed Nationwide in the USA.
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 CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Drug, reported February 19, 2020. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026