FDA recall, , Moderate risk
American Health Packaging Cyanocobalamin Injection
Cyanocobalamin Injection may contain glass particles.
Summary by Recall Canary from the FDA notice
What happened
American Health Packaging is voluntarily recalling Cyanocobalamin Injection, USP, 1,000 mcg/mL, Rx Only, 25 x 1mL Multiple-Dose Vials per carton, manufactured by American Regent, Inc. for Bluepoint Laboratories, due to potential glass particle contamination. The recall was initiated on October 22, 2026, and added to the FDA's Enforcement Report on November 3, 2026. The product was distributed nationwide in the USA.
The issue was identified when American Regent, Inc. notified BluePoint Pharmaceuticals Laboratories about a foreign glass fragment in the product batch. Customers were notified by letter. The recall is voluntary and firm initiated, involving 4,097 cartons of the product.
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
- 68001-542-60
- 68001-542-59
- Lot code
- 24394A
Recall details
- Posted by FDA
- Recall began
- Status
- Open
- Weekly archive
- Listed the week of Nov 2, 2026
- Sold in
Nationwide in the USA
- Recalled by
- American Health PackagingColumbus, Ohio
- Hazard
- Contamination
- 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
- 100204
- Recall number
- D-0173-2027
- Quantity recalled
- 4,097- cartons (25 x 1mL vials)
- Recall type
- Voluntary: Firm initiated
- How the company first told customers
- Letter
All recalls from American Health Packaging
Timeline
FDA's Enforcement Report is its public list of recalls; FDA posts a recall by adding it there.
American Health Packaging 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
