CLASS II Drug recall · Reported 6 Aug 2014 · FDA Enforcement Report
Phytobase Cream, Article number recalled by Fagron
Fagron is recalling Fagron, Phytobase Cream, Article number: 802156, distributed nationwide in the US. The recall was initiated on 24 Jul 2014 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-1496-2014
- FDA event ID
- 68896
- Recalling firm
- Fagron, Saint Paul, MN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Jul 2014
- FDA classified
- 30 Jul 2014
- Reported
- 6 Aug 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Mold
- Drug class
- Creams, Ointments & Gels
Timeline
| 24 Jul 2014 | Recall initiated by company | |
| 30 Jul 2014 | Classified by FDA | +6 days |
| 6 Aug 2014 | 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
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Product as listed by the FDA
Fagron, Phytobase Cream, 500 g, Article number: 802156. RX only, For prescription compounding Natural self-emulsifying oil-in water vehicle for oil-solvents ingredients. Contains Phytosomes (Plant Oil Bodies), Manufactured by Fagron, Inc. 2400 Pilot Knob Rd, St Paul, MN 55120, NDC 51552-1205-6.
Where it was distributed
Nationwide and Australia
Questions about this recall
Is Phytobase Cream, Article number: 802156 recalled?
Yes. Fagron recalled Phytobase Cream, Article number: 802156 on 24 Jul 2014. The recall is Class II and its status is Terminated. Recall number D-1496-2014.
Why was it recalled?
Microbial Contamination of Non-Sterile Products: Fagron is recalling six lots due to the presence of mold.
Which lots are affected?
Lot # 13J30-U17-015413; Exp 10/15 Lot # 13J30-U16-015425; Exp 10/15 Lot # 13I06-U05-014199; Exp 10/15
Where was it sold?
Nationwide and Australia
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 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 | Foreign Material | Nationwide |