Go Backs
HomeCategoriesStatesCheck Your Home
Go Backs

Track product recalls and safety alerts from CPSC, FDA, NHTSA, and USDA. Stay informed and keep your family safe.

Browse

  • Categories
  • States
  • Check Your Home
  • Risk Levels

Agencies

  • CPSC
  • FDA Food
  • FDA Drug
  • FDA Device
  • FDA Veterinary
  • NHTSA
  • USDA

Company

  • About
  • FAQ
  • Contact
  • Terms of Service
  • Privacy Policy
Buy Me a Coffee

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.

© 2026 Go Backs. All rights reserved.

Medium RiskFDA Drug

Fresenius Kabi USA, LLC: Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.

Agency Publication Date: July 9, 2014
Share:
Sign in to monitor this recall

Affected Products

Product: Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) 2 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-02

Lot # 6003850; 04/14 6003926; 05/14 6004052; 05/14 6004053; 05/14 6004093; 06/14 6004094; 06/14 6004199; 07/14 6004200; 07/14 6004509; 08/14 6004510; 08/14 6004661; 09/14 6005157; 11/14 6005158; 11/14 6005197; 11/14 6005198; 11/14 6005446; 01/15 6005447; 01/15 6005702; 03/15 6005703; 03/15 6005790; 03/15 6005791; 03/15 6006005; 05/15 6006006; 05/15 6006091; 05/15 6006211; 06/15 6006212; 06/15 6006396; 07/15 6006397; 07/15

Lot Numbers:
6003850
Product: Fosphenytoin Sodium Injection, USP, 500 mg PE/10 mL (50 mg PE/mL), (PE= phenytoin sodium equivalents) 10 mL Single Use Vial, Rx only, Manufactured for APP Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-403-10

Lot # 6003854; 04/14 6003855; 04/14 6004011; 05/14 6003961; 05/14 6004091; 06/14 6004092; 06/14 6004553; 08/14 6004554; 08/14 6004588; 09/14 6004589; 09/14 6005201; 12/14 6005202; 12/14 6005293; 12/14 6005294; 12/14 6005545; 02/15 6005546; 02/15 6005831; 03/15 6005832; 03/15 6005973; 04/15 6005974; 04/15 6006035; 05/15 6006036; 05/15 6006037; 05/15 6006174; 05/15 6006175; 05/15 6006176; 06/15 6006449; 07/15 6006450; 07/15 6006451; 07/15 6007168; 11/15

Lot Numbers:
6003854

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 68152
Status: Resolved
Manufacturer: Fresenius Kabi USA, LLC
Manufactured In: United States
Units Affected: 2 products (2,070,500 vials; 728,880 vials)

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.