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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

Fresenius Kabi Morphine Sulfate Injection Recalled for Cracked Vials

Agency Publication Date: September 28, 2021
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Summary

Fresenius Kabi USA LLC is recalling 963,000 vials of Morphine Sulfate Injection, USP (2 mg per mL) due to a defect where vials may be cracked. This defect could compromise the sterility of the medication, which is critical for injectable drugs. The recalled medication was sold in 1 mL single-dose vials packaged in trays of 25. No injuries or infections have been reported to date in connection with this issue.

Risk

A cracked vial can allow contaminants and bacteria to enter the sterile medication. If a contaminated drug is injected, it can lead to serious and potentially life-threatening infections.

What You Should Do

  1. This recall involves Fresenius Kabi Morphine Sulfate Injection, USP (2 mg per mL, 1 mL single dose vial) with NDC 63323-452-01.
  2. Identify affected products by checking for lot numbers 6023731, 6023732 (expiration 03/2023), 6024172, or 6024260 (expiration 06/2023).
  3. Stop using the recalled injection immediately and quarantine any remaining stock.
  4. Contact Fresenius Kabi USA LLC or your medical distributor to arrange for the return of the affected vials.
  5. Call the FDA Consumer Complaint hotline at 1-888-723-3332 for additional questions regarding this recall.

Your Remedy Options

๐Ÿ“‹Other Action

Manufacturer initiated recall due to container defect.

How to: Stop using the recalled product. Contact the manufacturer or your distributor to arrange return.

Affected Products

Product: Morphine Sulfate Injection, USP (2 mg per mL, 1 mL single dose vial)by Fresenius Kabi
Variants: 2 mg per mL, 1 mL single dose vial, Rx only
Lot Numbers:
6023731 (Exp 03/2023)
6023732 (Exp 03/2023)
6024172 (Exp 06/2023)
6024260 (Exp 06/2023)
NDC:
63323-452-01

Packaged 25 vials per tray, 18 trays per shipper.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 88698
Status: Resolved
Manufacturer: Fresenius Kabi USA LLC
Sold By: Hospitals; Clinics; Wholesalers
Manufactured In: United States
Units Affected: 963000 vials
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 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.