Fosphenytoin Sodium Injection (Fresenius) – Glass Particulates (2014)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
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
Brand
Fresenius Kabi USA, LLC
Lot Codes / Batch Numbers
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
Products Sold
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
Fresenius Kabi USA, LLC is recalling Fosphenytoin Sodium Injection, USP, 100 mg PE/2 mL (50 mg PE/mL) (PE= phenytoin sodium equivalents) due to Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Presence of Particular Matter: Potential glass delamination and consistent with glass particulates observed in sample vials.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 10, 2026