In the agency's Nov 11, 2026 enforcement report · Ongoing
Cyanocobalamin Injection, USP, 1,000 mcg/mL, Rx Only, 25 x 1mL -Multiple-Dose Vials per carton, Mfg. by: American…
American Health Packaging
Risk not classifiedThe agency has not ranked the risk yet — treat the notice as a caution.What you should do
Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.
Firm contact: American Health Packaging · 2550 John Glenn Ave Ste A · Columbus, OH · 43217-1188
Is this the product you have?
- Cyanocobalamin Injection, USP, 1,000 mcg/mL, Rx Only, 25 x 1mL -Multiple-Dose Vials per carton, Mfg
- byAmerican Regent, Inc., For Bluepoint Laboratories. Carton NDC 68001-542-60; Vial NDC 68001-542-59
- Lot codes and dates
- Lot
24394AExp 10-31-2026
- Lot
- Amount recalled
- 4,097- cartons (25 x 1mL vials)
This recall covers 2 products
The agency filed one notice per product. You are reading one of them; the other one is below.
Where it was sold
- Nationwide
Why it was recalled
Presence of particulate matter:American Regent, Inc. notified BluePoint Pharmaceuticals Laboratories regarding potential glass particle contamination (foreign glass fragment) identified in the product batch.
The agency has not ranked the risk yet — treat the notice as a caution.
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