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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/Prescription Drugs

Johnson Matthey Inc.: Fentanyl, Cisplatin, and Oxaliplatin Recalled for Potential Glass Contamination

Agency Publication Date: September 25, 2019
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Summary

Johnson Matthey Inc. has recalled approximately 396,210 units (over 395,000 grams) of three active pharmaceutical ingredients: Fentanyl Citrate, Cisplatin, and Oxaliplatin. These products, which are used to manufacture finished medications for pain and cancer treatment, were found to have potential glass contamination due to manufacturing deviations. Consumers and healthcare providers should be aware that these ingredients were distributed nationwide across the United States.

Risk

The presence of glass fragments in injectable or oral medications can lead to serious health complications, including internal irritation, inflammation, or trauma to the site of administration. No specific injuries have been reported in the provided data, but the contamination represents a significant manufacturing failure.

What You Should Do

  1. Check your medication records or packaging for Fentanyl Citrate API with lot numbers B0030-180101 or B0030-180102 and an expiration date of February 2023.
  2. Check for Cisplatin API with lot number B0101-161102 and an expiration date of December 2021.
  3. Check for Oxaliplatin API (NDC 49821-0075-XX) with lot numbers B0126-170701, B0126-170802 (Exp. Sep 2022), B0126-180401 (Exp. May 2023), B0126-180702, or B0126-180803 (Exp. Oct 2023).
  4. Contact your healthcare provider or pharmacist immediately for guidance if you believe you have received medication manufactured with these specific ingredients.
  5. Return any unused or affected product to the pharmacy or place of purchase for a refund.
  6. Contact the manufacturer, Johnson Matthey Inc., at (856) 384-7001 for further instructions regarding the return of these materials.
  7. For additional questions or to report a problem, 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

Contact healthcare provider and return for refund

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

Affected Products

Product: Fentanyl Citrate Active Pharmaceutical Ingredient
Lot Numbers:
B0030-180101 (Exp. Feb 2023)
B0030-180102 (Exp. Feb 2023)
Date Ranges: Feb 2023
Product: Cisplatin Active Pharmaceutical Ingredient
Lot Numbers:
B0101-161102 (Exp. Dec 2021)
Date Ranges: Dec 2021
Product: Oxaliplatin Active Pharmaceutical Ingredient
Model:
NDC 49821-0075-XX
Lot Numbers:
B0126-170701 (Exp. Sep 2022)
B0126-170802 (Exp. Sep 2022)
B0126-180401 (Exp. May 2023)
B0126-180702 (Exp. Oct 2023)
B0126-180803 (Exp. Oct 2023)
Date Ranges: Sep 2022, May 2023, Oct 2023

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83457
Status: Resolved
Manufacturer: Johnson Matthey Inc.
Sold By: Johnson Matthey Pharmaceutical Materials
Manufactured In: United States
Units Affected: 3 products (52882.23 grams; 26625 grams; 316703.32)
Distributed To: Nationwide
Agency Last Updated: October 2, 2019

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.