November 2025 FDA Recall Famotidine by Fresenius Kabi Usa, Llc
D-0182-2026 - Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
This Class I drug recall was voluntarily initiated by Fresenius Kabi Usa, Llc on November 6, 2025 for the product Famotidine. The FDA reported the reason for recall as microbial contamination of sterile products; out of limit results obtained for endotoxin testing.. The product was distributed Nationwide and the recall is currently ongoing.
Recall Number: D-0182-2026
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
11-06-2025
12-03-2025
2,199,850 vials
Recall Profile & Regulatory Data
Class I - is a situation in which there is a reasonable probability that the use of, or exposure to, a violative product will cause serious adverse health consequences or death.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Current regulatory stage of the recall event.
Ongoing
Recalling Firm About Recalling Firm
The firm responsible for the recall.
The firm responsible for the recall.
Fresenius Kabi USA, LLC
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
General area of initial distribution.
Nationwide within the United States as well as AK, HI, and PR.
Product Description About Product Description
Full technical description of the product.
Full technical description of the product.
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius Kabi USA, LLC, NDC 63323-739-11 (unit of use), 63323-739-12 (unit of sale).
Batch or Lot Expiration Information
Lot# : 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
