FDA recall, , Moderate risk
American Regent Cyanocobalamin Injection
Cyanocobalamin Injection contains particulate matter identified as glass.
Summary by Recall Canary from the FDA notice
What happened
American Regent, Inc., of Shirley, New York, voluntarily recalled Cyanocobalamin Injection, USP, 1000 mcg/mL, 25 x 1 mL multi-dose vials, Rx only, because the product contains particulate matter identified as glass. The recall began on October 14, 2026, and was added to the FDA's Enforcement Report on October 27, 2026.
The product is distributed nationwide within the United States. 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.
- NDC
- 0517-0031-25
- 0517-0031-01
- Lot code
- 24394
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Oct 26, 2026
- Sold in
Nationwide within the United States
- Recalled by
- American Regent, Inc.Shirley, New York
- Hazard
- Foreign object
- Risk
Moderate risk
Taking it may cause short-term health problems, or ones that treatment can reverse. Serious harm is unlikely.
FDA Class II recall · How risk is rated
- FDA event number
- 100143
- Recall number
- D-0172-2027
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from American Regent, Inc.
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
American Regent began the recall
FDA posted the recall to its Enforcement Report
Added to Recall Canary
FDA rated the recall Class II (moderate risk)
Summary updated
