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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.: Morphine Sulfate API Recalled for Microbial Contamination

Agency Publication Date: April 3, 2019
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Summary

Johnson Matthey Inc. has recalled approximately 170 kilograms of Morphine Sulfate USP Milled, which is an active pharmaceutical ingredient (API) used to manufacture morphine medications. The recall was issued because testing revealed that the bioburden—the number of bacteria living on a surface that has not yet been sterilized—was higher than the required safety specifications. This batch of milled morphine sulfate is for prescription use only and was distributed nationwide to further manufacturers. Consumers should consult their healthcare provider or pharmacist if they have concerns about medications they are currently taking.

Risk

The product exceeds microbial limits, which could introduce harmful bacteria into finished drug products. This poses a risk of infection or other adverse health effects to patients who consume medications made from this contaminated batch.

What You Should Do

  1. Check the labeling of your medication or contact your pharmacist to see if your prescription was manufactured using Morphine Sulfate USP Milled from Johnson Matthey Inc., specifically Lot# B1414-160809 with a retest date of August 2021.
  2. If you are a manufacturer or pharmacist in possession of this raw API material, immediately stop using the affected lot and quarantine all remaining stock.
  3. Patients should contact their healthcare provider or pharmacist for guidance before stopping any prescribed morphine medication.
  4. Return any unused or affected product to the place of purchase for a refund and contact Johnson Matthey Inc. at their New Jersey facility for further instructions.
  5. 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

💰Full Refund

Contact healthcare provider and return product 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: Morphine Sulfate USP Milled, Active Pharmaceutical Ingredient (169.976 kg)
Model:
Recall #: D-1077-2019
Lot Numbers:
B1414-160809
Date Ranges: Retest Date AUG 2021

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 82298
Status: Resolved
Manufacturer: Johnson Matthey Inc.
Sold By: Pharmaceutical manufacturers; Wholesale distributors
Manufactured In: United States
Units Affected: 169.976 kg
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 · 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.