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

G-Supress DX Pediatric Drops Recalled for Product Mix-Up

Agency Publication Date: May 26, 2023
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Summary

Novis PR, LLC dba Kramer Novis is recalling 9,077 bottles of G-Supress DX (dextromethorphan HBr, guaifenesin, and phenylephrine HCl) Pediatric Drops because a product mix-up was discovered. An incorrect product was found inside the G-Supress DX product cartons, meaning consumers might accidentally administer the wrong medication. This recall affects the 30 mL (1 oz) cherry-flavored bottles sold at pharmacies and retailers in Puerto Rico.

Risk

A product mix-up can lead to consumers taking or administering the wrong medication, which can cause serious health complications or result in the failure to treat the intended symptoms. No incidents or injuries have been reported to date.

What You Should Do

  1. This recall affects G-Supress DX (dextromethorphan HBr, guaifenesin, and phenylephrine HCl) Pediatric Drops sold in 30 mL (1 oz) bottles with NDC 52083-655-01.
  2. Identify the affected product by checking the carton or bottle label for lot number D20911 and an expiration date of October 2025.
  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 Kramer Novis at 1-787-767-2072 for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions.

Your Remedy Options

You have 2 options:

💰Option 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
🗑️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: G-Supress DX Pediatric Drops (30 mL)
Variants: Cherry Flavor, Sugar & Alcohol Free, Pediatric Drops
Lot Numbers:
D20911 (Exp. Oct/25)
NDC:
52083-655-01

Recall #: D-0868-2023

Product Images

“G-SUPRESS DX, Pediatric Drops, Cough Suppressant, Expectorant, Nasal Decongestant, Cherry Flavor, 30 ml”

“G-SUPRESS DX, Pediatric Drops, Cough Suppressant, Expectorant, Nasal Decongestant, Cherry Flavor, 30 ml”

"G-SUPRESS DX, Pediatric Drops, Cough Suppressant, Expectorant, Nasal Decongestant, Cherry Flavor, 30 ml"

"G-SUPRESS DX, Pediatric Drops, Cough Suppressant, Expectorant, Nasal Decongestant, Cherry Flavor, 30 ml"

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 92324
Status: Resolved
Manufacturer: Novis PR, LLC dba Kramer Novis
Sold By: Pharmacies; Retailers
Manufactured In: United States
Units Affected: 9077 bottles
Distributed To: Puerto Rico
Agency Last Updated: June 6, 2023

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 · FDA Press Release (1) · FDA Press Release (2) · FDA Press Release (3) · 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.