Fagron recalls NYSTATIN 2 BU bulk powder due to incorrect label strength. This affects prescription compounding products with specific NDC and lot numbers. Consumers should contact the manufacturer for details.
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Fagron is recalling NYSTATIN 2 BU bulk powder containers because the label shows an incorrect strength. This could lead to improper dosing if used in prescription compounding. The recall affects specific products with known NDC and lot numbers.
The label incorrectly states the strength of the NYSTATIN 2 BU bulk powder. This error could cause improper dosing if the compounding pharmacist uses the product without verifying the actual strength. The hazard is specific to prescription compounding and does not affect end-users.
Prescription compounding pharmacies and healthcare professionals using the specific NYSTATIN 2 BU bulk powder containers with NDC 51552-0041-4 and lots 230308-U46224 or 221031-U42105 are most at risk.
Check for the NDC code 51552-0041-4 on the container. Look for lot numbers 230308-U46224 or 221031-U42105. The product is sold for prescription compounding only.
Reach out to Fagron, Inc. at 2400 Pilot Knob Rd., St Paul, MN 55120 for specific guidance on the recalled product.
The product is safe for use if the compounding pharmacist verifies the actual strength before use. The label error does not affect the product's safety but requires careful handling.
Contact Fagron, Inc. directly for instructions on handling the recalled product. The recall does not require immediate disposal.
Check the NDC code 51552-0041-4 and lot numbers 230308-U46224 or 221031-U42105 on the container. The product is for prescription compounding only.
We’ve drafted a message you can send Fagron to request your refund or repair — edit it as you like.
Subject: Recall D-0156-2024 — Fagron Fagron Hello, I own a Fagron that is covered by recall D-0156-2024 from Fagron. I’m writing to arrange the remedy described in the recall (a refund, repair, or replacement as applicable). Could you please tell me the next steps to resolve this? Thank you.
Experiences, tips, and questions from readers. Every comment is reviewed before it appears.
No comments yet — be the first to share your experience.
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
