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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Over-the-Counter

Efficient Laboratories, Inc.: Rompe Pecho Cold, Flu, and Expectorant Recalled for Microbial Contamination

Agency Publication Date: February 13, 2020
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Summary

Efficient Laboratories, Inc. is recalling 14,716 bottles of Rompe Pecho CF Cold & Flu, Rompe Pecho EX Expectorant, and Rompe Pecho MAX Multi-Symptoms medications. These non-sterile liquid products were found to have microbial contamination, which could lead to serious infections, especially in vulnerable populations. The affected products include 6-ounce and 8-ounce bottles distributed nationwide throughout the United States.

Risk

The contamination involves microorganisms in a non-sterile drug product, which can cause illness or infection if ingested. While the risk to healthy individuals may be lower, it poses a significant threat to those with weakened immune systems or underlying health conditions.

What You Should Do

  1. Check your medicine cabinet for Rompe Pecho CF Cold & Flu (6 Fl. Oz) with UPC 0 00856 33106 8 and Lot 19H359 (Exp. August 2022).
  2. Check for Rompe Pecho EX Expectorant (6 Fl. Oz) with UPC 0 00856 30106 1 and Lot 19F332 (Exp. June 2022).
  3. Check for Rompe Pecho MAX Multi Symptoms (8 Fl. Oz) with UPC 0 00856 00309 5 and Lot 19B42 (Exp. February 2022).
  4. Immediately stop using these products and do not ingest them.
  5. Contact your healthcare provider or pharmacist for guidance regarding your health and the use of these medications.
  6. Return any unused product to the pharmacy or place of purchase for a refund, and contact Efficient Laboratories, Inc. at 7715 NW 64th St, Miami, Florida for further instructions.
  7. For additional questions or to report a complaint, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Full refund upon return of product.

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Rompe Pecho CF Cold & Flu with Honey (6 FL. Oz / 178 mL)
Model:
D-0845-2020
UPC Codes:
000856331068
Lot Numbers:
19H359 (Exp. August 2022)
Date Ranges: August 2022
Product: Rompe Pecho EX Expectorant (6 FL. Oz / 178 mL)
Model:
D-0846-2020
UPC Codes:
000856301061
Lot Numbers:
19F332 (Exp. June 2022)
Date Ranges: June 2022
Product: Rompe Pecho MAX Multi Symptoms (8 FL. Oz / 237 mL)
Model:
D-0847-2020
UPC Codes:
000856003095
Lot Numbers:
19B42 (Exp. February 2022)
Date Ranges: February 2022

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 84864
Status: Resolved
Manufacturer: Efficient Laboratories, Inc.
Sold By: Retailers nationwide
Manufactured In: United States
Units Affected: 3 products (5249 6 Fl Oz bottles; 5387 6 Fl Oz bottles; 4080 8 FL Oz bottles)
Distributed To: Nationwide
Agency Last Updated: February 14, 2020

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.