CLASS II ONGOING Drug recall · Reported 27 Dec 2023 · FDA Enforcement Report
Nystatin 2 BU, Activity (as is):/mg, bulk powder container recalled
Fagron is recalling Nystatin 2 BU, Activity (as is):/mg, bulk powder container. The recall was initiated on 11 Dec 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0156-2024
- FDA event ID
- 93594
- Recalling firm
- Fagron, Saint Paul, MN
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 11 Dec 2023
- FDA classified
- 21 Dec 2023
- Reported
- 27 Dec 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Compounded Drugs
Timeline
| 11 Dec 2023 | Recall initiated by company | |
| 21 Dec 2023 | Classified by FDA | +10 days |
| 27 Dec 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
NYSTATIN 2 BU, Activity (as is): 6482 Units/mg, bulk powder container, Rx Only, For Prescription Compounding, Fagron, Inc. - 2400 Pilot Knob Rd. St Paul, MN 55120. NDC 51552-0041-4, Bar code 3 51552 00414 6
Where it was distributed
Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
Questions about this recall
Is Nystatin 2 BU, Activity (as is):/mg, bulk powder container recalled?
Yes. Fagron recalled Nystatin 2 BU, Activity (as is):/mg, bulk powder container on 11 Dec 2023. The recall is Class II and its status is Ongoing. Recall number D-0156-2024.
Why was it recalled?
Labeling: Label Error on Declared Strength: Assay value on the label is incorrect.
Which lots are affected?
Lot #: 230308-U46224, Exp. date 04/30/2025, 221031-U42105, Exp. date 04/30/2025
Where was it sold?
Product was distributed to 1 distributor and may have further distributed the product to repacker/relabelers and pharmacies in the United States and Canada to be used for prescription compounding.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Fagron
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nystatin 150 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 500 MU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS II | Nystatin 5BU, Activity (as is):/mg, bulk powder container recalled | Fagron | Potency & Assay | MN |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Foreign Material | Nationwide |
| Drug | CLASS I | SyrSpend SF Suspending Base, Cherry Flavored recalled by Fagron | Fagron | Sterility | Nationwide |