FDA recall,
Sagent Pharmaceuticals Famotidine Injection
Famotidine Injection contains particulate matter.
Summary by Recall Canary from the FDA notice
What happened
Sagent Pharmaceuticals, of Schaumburg, Illinois, is voluntarily recalling Famotidine Injection, 200 mg per 50 mL (4 mg per mL), 1 x 50 mL Multi-Dose Vial, For Intravenous Use, Rx only, Sterile, because it contains particulate matter. The company began the recall on October 22, 2026, and the FDA added it to the Enforcement Report on November 3, 2026.
The recall affects 1,720 vials distributed nationwide. Customers were notified by letter.
What to do
The FDA notice gives no instructions for this recall. FDA's general advice for medicine recalls:
- Check the FDA or company notice for instructions specific to this product.
- Ask your pharmacist or doctor whether your lot is affected and what to do.
Is yours affected?
Match the NDC and lot code listed under your product.
An NDC (National Drug Code) is usually printed on the drug's label.
Famotidine Injection
- NDC
- 25021-756-50
- Lot code
- E243A001
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
US Nationwide
- Recalled by
- Sagent PharmaceuticalsSchaumburg, Illinois
- Hazard
- Foreign object
- Risk
Not yet rated by FDA
- FDA event number
- 100208
- Quantity recalled
- 1,720 vials
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from Sagent Pharmaceuticals
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
Sagent Pharmaceuticals began the recall
FDA posted the recall to its Enforcement Report
Added to Recall Canary
