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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

Rompe Pecho Cold and Flu Medications Recalled for Microbial Contamination

Agency Publication Date: December 22, 2021
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Summary

Efficient Laboratories, Inc. is recalling approximately 49,865 bottles of Rompe Pecho cold and flu medications, including formulations for cough, congestion, and maximum strength multi-symptom relief. These medications, which contain active ingredients such as guaifenesin, dextromethorphan, acetaminophen, and phenylephrine, are being recalled because they may be contaminated with microbes. No illnesses or injuries have been reported to date in connection with these products.

Risk

Non-sterile products contaminated with microbes can cause serious infections, particularly in consumers with weakened immune systems or underlying health conditions.

What You Should Do

  1. This recall affects various Rompe Pecho brand cold and flu medications sold in 4 oz., 6 oz., and 8 oz. bottles with NDC codes 58593-235-06, 58593-275-06, 58593-829-04, 58593-829-06, and 58593-828-08.
  2. Check the lot number and expiration date printed on the bottle or outer carton. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Efficient Laboratories, Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Rompe Pecho CF Cold & Flu Advanced Formula (6 fl. oz.)
Variants: Guaifenesin
Lot Numbers:
19F88 (Exp. June 2022)
19G164 (Exp. July 2022)
NDC:
58593-235-06

Distributed by Efficient Laboratories, Inc. Miami, FL 33166

Product: Rompe Pecho DM (6 fl. oz.)
Variants: Dextromethorphan
Lot Numbers:
19F168 (Exp. June 2022)
19G145 (Exp. July 2022)
19G361 (Exp. July 2022)
19G449 (Exp. July 2022)
19G491 (Exp. July 2022)
NDC:
58593-275-06

Distributed by Efficient Laboratories, Inc. Miami, FL 33166

Product: Rompe Pecho Ex Expectorant (4 fl. oz.)
Variants: Guaifenesin
Lot Numbers:
19H20 (Exp. August 2022)
19A418 (Exp. January 2022)
19E411 (Exp. May 2022)
NDC:
58593-829-04

Distributed by Efficient Laboratories, Inc. Miami, FL 33166

Product: Rompe Pecho Ex Expectorant (6 fl. oz.)
Variants: Guaifenesin
Lot Numbers:
19H20 (Exp. August 2022)
19J98 (Exp. September 2022)
19A418 (Exp. January 2022)
19E411 (Exp. May 2022)
NDC:
58593-829-06

Distributed by Efficient Laboratories, Inc. Miami, FL 33166

Product: Rompe Pecho Max Multi-Symptoms Maximum Strength (8 fl. oz.)
Variants: Acetaminophen, Guaifenesin, Phenylephrine
UPC Codes:
000856003095
Lot Numbers:
19G219 (Exp. July 2022)
NDC:
58593-828-08

Distributed by Efficient Laboratories, Inc. Miami, FL 33166

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89205
Status: Resolved
Manufacturer: Efficient Laboratories, Inc.
Manufactured In: United States
Units Affected: 4 products (10,833 bottles; 27,206 bottles; a) 7,800 bottles; b) 16,417 bottles; 4,026 bottles)
Distributed To: Nationwide

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.