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)
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
- Agency
- FDA Drug
- Recall date
- Nov 6, 2025
- Status
- Ongoing
- Company
- Fresenius Kabi USA, LLC
1. What product was recalled?
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)
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).
Quantity: 2,199,850 vials
Code or lot text: Lot #: 6133156, 6133194, Exp Date: 08/2026; 6133388, Exp Date: 10/2026.
- LOT
- 6133194
- LOT
- 6133388
- LOT
- Exp Date: 08/2026
- LOT
- Exp Date: 10/2026.
- LOT
- Lot #: 6133156
- NDC
- 63323-739
- NDC
- 63323-739-11
- NDC
- 63323-739-12
- RECALL-NUMBER
- D-0182-2026
- UPC
- 0363323739119
2. Is my exact product affected?
Compare every printed identifier. A matching value can indicate that your product is included.
3. What is the hazard?
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
4. What should I do now?
Follow the FDA recall notice and contact the recalling company for current instructions.
5. Where was it sold or distributed?
Nationwide
View source evidence for state distribution
- Alaska: Nationwide within the United States as well as AK, HI, and PR.
- Hawaii: Nationwide within the United States as well as AK, HI, and PR.
- Puerto Rico: Nationwide within the United States as well as AK, HI, and PR.
6. Were injuries or illnesses reported?
No separate injury or illness statement was present in the normalized record. Check the official source for the latest report.
7. What remedy is available?
Follow the FDA recall notice and contact the recalling company for current instructions.
8. Is the recall active or closed?
The source status is Ongoing. The Recall Guy's urgency label is urgent, which is a separate deterministic site label.
9. When was the information checked?
Last checked .
- created
10. Where is the official source?
Open the official FDA Drug source
The Recall Guy normalizes public source data for easier checking. Source agencies remain authoritative. Confirm identifiers and instructions at the official source.