Recall archive / FDA company announcement

Fresenius Kabi: Famotidine Injection, USP 20 mg per 2 mL — FDA announcement Nov 7, 2025

Published notice; closure not supplied

A company announcement posted by FDA. The listing date can differ from the original announcement date. The absence of a termination marker does not prove the recall is currently ongoing.

Source date Nov 7, 2025. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Famotidine Injection, USP 20 mg per 2 mL
Reason: Out-of-specification endotoxin results
Classification: Not supplied
Recalling firm: Fresenius Kabi USA, LLC
Quantity: Not supplied
Agency-reported status: Company recall announcement
Source record identifier: bcab302683fb2517

Open the official record

Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.; Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death. Non-serious adverse event reports potentially associated with the OOS have been received for one lot. These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking. To date, no adverse event reports have been received for the second and third lots.; Product Name/Product Size \| Unit of Use NDC Number \| Unit of Sale NDC Number \| Product Code \| Batch Number \| Expiration Date \| First Ship Date \| Last Ship Date; Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2mL fill in a 2 mL vial \| 63323-739-11 \| 63323-739-12 \| 730912 \| 6133156 \| 08/2026 \| 01/02/2025 \| 02/11/2025; 6133194 \| 08/2026 \| 02/04/2025 \| 04/11/2025; 6133388 \| 10/2026 \| 04/15/2025 \| 05/23/2025

Label field

Details supplied by the agency

Lot, code or applicability

The product is being recalled due to out-of-specification (OOS) endotoxin results of certain reserve samples from a single lot. Based upon the investigation, two additional lots were also included in the recall as a precautionary measure.; Elevated endotoxin levels can precipitate severe systemic reactions such as sepsis and septic shock. Severe responses may include inflammatory and life-threatening immune responses and death. Non-serious adverse event reports potentially associated with the OOS have been received for one lot. These non-serious adverse events included chills, change in mental status, change in respiratory status, fever, increase in body temperature, shivering and shaking. To date, no adverse event reports have been received for the second and third lots.; Product Name/Product Size | Unit of Use NDC Number | Unit of Sale NDC Number | Product Code | Batch Number | Expiration Date | First Ship Date | Last Ship Date; Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2mL fill in a 2 mL vial | 63323-739-11 | 63323-739-12 | 730912 | 6133156 | 08/2026 | 01/02/2025 | 02/11/2025; 6133194 | 08/2026 | 02/04/2025 | 04/11/2025; 6133388 | 10/2026 | 04/15/2025 | 05/23/2025

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Product tables from the announcement

These identifying details come from the company announcement posted by FDA. Check the current notice for revisions.

FDA company announcement, table 1
Product Name/Product Size	Unit of Use NDC Number	Unit of Sale NDC Number	Product Code	Batch Number	Expiration Date	First Ship Date	Last Ship Date
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2mL fill in a 2 mL vial	63323-739-11	63323-739-12	730912	6133156	08/2026	01/02/2025	02/11/2025
				6133194	08/2026	02/04/2025	04/11/2025
				6133388	10/2026	04/15/2025	05/23/2025

Announcement retrieved Oct 1, 2026. Official announcement.

Distribution

Not supplied

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Fda listing date: Nov 7, 2025
Company announcement date: Nov 6, 2025

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.