--- title: "Fresenius Kabi: Famotidine Injection, USP 20 mg per 2 mL — FDA announcement Nov 7, 2025 | Is It on Recall" description: "Out-of-specification endotoxin results" url: https://isitonrecall.com/recall/fdapress-bcab302683fb2517-fresenius-kabi-famotidine-injection-usp-20-mg-per-2-ml/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Recall archive](https://isitonrecall.com/archives/) / 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](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## 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](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10) ## 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 | Match all identifying details in the current notice. A brand name alone is not enough. ## 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 | | 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 | 6133194 | 08/2026 | 02/04/2025 | 04/11/2025 | | 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 | 6133388 | 10/2026 | 04/15/2025 | 05/23/2025 | Announcement retrieved Oct 1, 2026. [Official announcement](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10). ## 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. ## What to do next Consumers with questions regarding this recall can contact Fresenius Kabi USA Quality Assurance at 1-866-716-2459, Monday through Friday, during the hours of 8:00 a.m. to 5:00 p.m. Central Standard Time. Patients should contact their physician or health care provider if they have experienced any problems that may be related to receiving this drug product. [Read the current instructions](https://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/fresenius-kabi-issues-voluntary-nationwide-recall-three-lots-famotidine-injection-usp-20-mg-2-ml-10) ## Before changing a medicine Follow urgent instructions in the current official recall notice. Speak to your pharmacist or prescriber before stopping or changing a prescribed medicine. Talk to your doctor or pharmacist if you have questions or concerns about your medicine. [FDA medication recall guidance](https://www.fda.gov/drugs/drug-recalls/understanding-drug-recalls-what-know-and-what-do) ## Related records [Famotidine records](https://isitonrecall.com/drug/famotidine/) [Medications records](https://isitonrecall.com/category/medications/) [Fresenius Kabi USA, LLC records](https://isitonrecall.com/brand/fresenius-kabi-usa-llc/)