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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

Preferred Pharmaceuticals, Inc: Robafen DM Recalled for Potential Bacterial Contamination

Agency Publication Date: June 20, 2019
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Summary

Preferred Pharmaceuticals, Inc. is recalling 192 bottles of Robafen DM (a generic version of Robitussin DM) due to potential contamination with Burkholderia cepacia and Ralstonia pickettii bacteria. This recall includes 4 oz bottles of the cough and cold medication manufactured for Preferred Pharmaceuticals by Major Pharmaceuticals. Consumers should be aware that these bacteria can cause serious infections, particularly in individuals with weakened immune systems. If you have this product at home, you should immediately contact your healthcare provider or pharmacist for guidance.

Risk

The product may contain Burkholderia cepacia and Ralstonia pickettii, which are bacteria that can lead to life-threatening infections in people with cystic fibrosis or compromised immune systems. Healthy individuals might experience milder infections, but the presence of these pathogens in a liquid medication poses a significant health risk.

What You Should Do

  1. Check your medicine cabinet for 118mL (4oz) bottles of Robafen DM (Generic for Robitussin DM) with NDC number 68788-0841-01.
  2. Specifically look for Lot J0218L (Batch 10021812) with an expiration date of 02/2020.
  3. Check also for Lot L2718D with batch numbers ranging consecutively from L2718D001 to L2718D096 and an expiration date of 07/2020.
  4. Immediately stop using the affected medication and contact your healthcare provider or pharmacist to discuss alternative treatments.
  5. Return any unused portion of the recalled product to the pharmacy where you purchased it for a full refund.
  6. Contact Preferred Pharmaceuticals, Inc. directly at their Anaheim, California location if you have questions regarding the return process.
  7. For additional information or to report a side effect, 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

Healthcare consultation and pharmacy refund.

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

Affected Products

Product: Robafen DM, Generic for Robitussin DM (118mL / 4oz)
Model:
NDC 68788-0841-01
Recall #: D-1410-2019
Lot Numbers:
J0218L (Batch: 10021812)
L2718D (Batch numbers L2718D001 to L2718D096)
Date Ranges: Exp. 02/2020, Exp. 07/2020

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83101
Status: Resolved
Manufacturer: Preferred Pharmaceuticals, Inc
Sold By: Major Pharmaceuticals
Manufactured In: United States
Units Affected: 192 4 oz bottles
Distributed To: California, Florida

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.