CLASS III Drug recall · Reported 18 May 2022 · FDA Enforcement Report
Nandrolone Decanoate recalled by Fagron
Fagron is recalling Nandrolone Decanoate, USP per, distributed nationwide in the US. The recall was initiated on 4 Mar 2022 and the FDA has classified it as Class III.
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-0863-2022
- FDA event ID
- 89797
- Recalling firm
- Fagron, Saint Paul, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 4 Mar 2022
- FDA classified
- 11 May 2022
- Reported
- 18 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Compounded Drugs
Timeline
| 4 Mar 2022 | Recall initiated by company | |
| 11 May 2022 | Classified by FDA | +68 days |
| 18 May 2022 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug
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
Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescription Compounding, Fagron, Inc. 2400 Pilot Knob Rd., St Paul, MN 55120. NDC 51552-1564-05
Where it was distributed
Nationwide within the USA
Questions about this recall
Why was it recalled?
Subpotent Drug
Which lots are affected?
Lot #: 18H02-U02-044978, 18L12-U02-050018, Exp. Date 10/31/2022 18L12-U02-000952, Exp. Date Sep 2023
Where was it sold?
Nationwide within the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 89797This product is part of a recall event; the main page for the event is Nandrolone Decanoate recalled by Fagron.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide | |
| CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide | |
| CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide | |
| CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |
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 2 BU, 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 | Potency & Assay | Nationwide |
Other Nandrolone Decanoate recalls
All 15| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nandrolone Decanoate 200mg/mL, a)-vial, b)-vial recalled | TMC Acquisition | Sterility | Nationwide |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |
| Drug | CLASS III | Nandrolone Decanoate recalled by Fagron | Fagron | Potency & Assay | Nationwide |