Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported December 3, 2025
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.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Fresenius Kabi USA, LLC recalled Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius … - a critical-severity action.
Famotidine Injection, USP, 20 mg per 2 mL (10 mg per mL), 2 mL vials, Rx only, Fresenius … was recalled by Fresenius Kabi USA, LLC in December 3, 2025. Reason: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.. Check the official notice for the remedy. Verify recall #D-0182-2026 with the FDA Drug before acting.
The recall
Fresenius Kabi USA, LLC issued this critical-severity FDA Drug recall-Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing..
- Critical
- severity level
- Class I
- classification
- December 3, 2025
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0182-2026 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0182-2026) was formally reported on December 3, 2025, with the manufacturer initiating the action on November 6, 2025. It is classified under Critical severity (Class I), with a current status of Ongoing. Fresenius Kabi USA, LLC is listed as the recalling firm, operating out of Lake Zurich, IL. Federal records list the affected scope as 2,199,850 vials.
The documented reason for this recall is: Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing. Distribution data in the federal record shows the product reached: Nationwide within the United States as well as AK, HI, and PR.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
2,199,850 vials
Related Recalls
6
5 from same agency
Product description
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).
Reason for recall
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0182-2026 |
| Date reported | December 3, 2025 |
| Date initiated | November 6, 2025 |
| Recalling firm | Fresenius Kabi USA, LLC |
| Firm location | Lake Zurich, IL |
| Affected scope | 2,199,850 vials |
| Distribution | Nationwide within the United States as well as AK, HI, and PR. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0182-2026) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
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).. Recalled by Fresenius Kabi USA, LLC. Units affected: 2,199,850 vials.
Why was this product recalled? ▼
Microbial Contamination of Sterile Products; out of limit results obtained for endotoxin testing.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on December 3, 2025. Severity: Critical. Recall number: D-0182-2026.
Where was the recalled product distributed? ▼
Distribution: Nationwide within the United States as well as AK, HI, and PR..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0182-2026) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Vitamin B-Complex, Vitamin C & Folic Acid Dietary Supplement, Net Wt. 8 FL Oz (237mL) Amber PET modern round 24-400 bot…
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Atomoxetine Capsules HCL, 10 mg Capsules in unit dose foil strip, strips are packed in cartons of 100, Rx Only, Pkg by:…
Safecor Health, LLC · 2026-05-27
FDA Drug Moderate
fentaNYL Citrate, Sterile CADD for Injection, 2,2500 mcg/50mL in Sterile Water, IntegraDose Compounding Services LLC, 3…
IntegraDose Compounding Services LLC · 2026-05-27
FDA Drug Moderate
Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, …
Lupin Pharmaceuticals Inc. · 2026-05-27
Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported December 3, 2025. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.