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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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High RiskFDA Drug
Medications & Supplements/Prescription Drugs

Woodfield Pharmaceutical, LLC: Codeine-Guaifenesin Oral Solution Recalled for Potential Bacterial Contamination

Agency Publication Date: January 8, 2018
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Summary

Woodfield Pharmaceutical is recalling 15,707 bottles of Codeine-Guaifenesin Oral Solution (10-100 mg/5 mL), a cough suppressant and expectorant. This recall affects the 16 fl. oz. bottles manufactured for Method Pharmaceuticals, LLC. The product may be contaminated with Burkholderia cepacia, a type of bacteria that can cause serious infections, particularly in individuals with weakened immune systems. This liquid medication was distributed in Texas and is identifiable by its specific lot number and expiration date.

Risk

The product may contain Burkholderia cepacia bacteria, which can cause severe respiratory infections or other serious illnesses. People with underlying lung conditions like cystic fibrosis or those with compromised immune systems are at a significantly higher risk of life-threatening infections if they use the contaminated solution.

What You Should Do

  1. Check your medicine cabinet for 16 fl. oz. bottles of Codeine-Guaifenesin Oral Solution (10-100 mg/5 mL) labeled 'Manufactured For: Method Pharmaceuticals, LLC'.
  2. Look for Lot number 08616 with an expiration date of 07/18 (July 2018) and NDC 58657-500-16 to determine if your product is part of this recall.
  3. If you have this specific lot, stop using the medication immediately and contact your healthcare provider or pharmacist for guidance on alternative treatments.
  4. Return any unused product to the pharmacy or place of purchase for a refund and contact Woodfield Pharmaceutical, LLC at 10863 Rockley Rd, Houston, Texas for further instructions.
  5. For any questions regarding this recall, 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
How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant (16 fl. oz.)
Model:
NDC 58657-500-16
Recall #: D-0210-2018
Lot Numbers:
08616 (Exp. 07/18)
Date Ranges: July 2018

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 78757
Status: Resolved
Manufacturer: Woodfield Pharmaceutical, LLC
Sold By: Method Pharmaceuticals, LLC
Manufactured In: United States
Units Affected: 15,707 bottles
Distributed To: Texas

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.