Multi-event February 2026 FDA Recall Drug by Fresenius Kabi Compounding, Llc

This Multi-event Class II drug recall was voluntarily initiated by Fresenius Kabi Compounding, Llc on February 5, 2026 for the product Drug. The FDA reported the reason for recall as lack of assurance of sterility. The product was distributed Nationwide and the recall is currently ongoing.

Reported Recall Events

D-0336-2026 ONGOING D-0334-2026 ONGOING D-0335-2026 ONGOING D-0337-2026 ONGOING D-0333-2026 ONGOING

Recall Number: D-0336-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-05-2026
Reported
02-18-2026
Quantity
1578 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98391
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
vancomycin HCl, 1.5 grams, 1.5 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-016-59

Batch or Lot Expiration Information

Lot# C274-000049628, Exp Date: 3-May-26.

Recall Number: D-0334-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-05-2026
Reported
02-18-2026
Quantity
1410 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98391
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
ketamine HCl, 1,000 mg, 1,000 mg per 100 mL (10 mg per mL) in Sodium Chloride Injection, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-050-56

Batch or Lot Expiration Information

Lot# C274-000047883, Exp Date: 17-Feb-26
Lot# C274-000048515, Exp Date: 22-Mar-26
Lot# C274-000048679, Exp Date: 31-Mar-26
Lot# C274-000049119, Exp Date: 19-Apr-26
Lot# C274-000049282, Exp Date: 27-Apr-26

Recall Number: D-0335-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-05-2026
Reported
02-18-2026
Quantity
10,548 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98391
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
thiamine HCl, 500 mg, 500 mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-079-56.

Batch or Lot Expiration Information

Lot# C274-000047651, Exp Date: 7-Feb-26
Lot# C274-000048671, Exp Date: 30-Mar-26
Lot# C274-000048828, Exp Date: 7-Apr-26
Lot# C274-000049121, Exp Date: 19-Apr-26
Lot# C274-000049127, Exp Date: 21-Apr-26
Lot# C274-000049252, Exp Date: 26-Apr-26
Lot# C274-000049260, Exp Date: 28-Apr-26
Lot# C274-000049401, Exp Date: 3-May-26
Lot# C274-000049413, Exp Date: 5-May-26
Lot# C274-000049571, Exp Date: 10-May-26
Lot# C274-000049581, Exp Date: 12-May-26
Lot# C274-000049584, Exp Date: 13-May-26
Lot# C274-000049717, Exp Date: 17-May-26
Lot# C274-000049727, Exp Date: 18-May-26.

Recall Number: D-0337-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-05-2026
Reported
02-18-2026
Quantity
N/A

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98391
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
vancomycin HCl, 2 grams, 2 grams added to 500 mL, 0.9% Sodium Chloride Injection, USP, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-019-59.

Batch or Lot Expiration Information

Lot# C274-000047611, Exp Date: 10-Feb-26
Lot# C274-000049633, Exp Date: 12-May-26.

Recall Number: D-0333-2026

Reason for Recall
Lack of Assurance of Sterility
Initiated
02-05-2026
Reported
02-18-2026
Quantity
1057 bags

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
98391
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class II - is 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
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Fresenius Kabi Compounding, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
US Nationwide.
Product Description About Product Description
Full technical description of the product.
acyclovir sodium, 200 mg, 200mg added to 100 mL, 0.9% Sodium Chloride Injection, USP, For Intravenous Use, Single-Use Bag, Fagron Sterile Services, 20 Dan Road, Canton, MA 02021, NDC 71506-035-56

Batch or Lot Expiration Information

Lot# C274-000049124, Exp Date: 28-Feb-26.