CLASS III Drug recall · Reported 10 May 2017 · FDA Enforcement Report
Zinc Oxide Paste 25%, For Prescription Compounding recalled by Fagron
Fagron is recalling Zinc Oxide Paste 25%, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St, distributed nationwide in the US. The recall was initiated on 17 Apr 2017 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-0695-2017
- FDA event ID
- 77018
- Recalling firm
- Fagron, Saint Paul, MN
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 17 Apr 2017
- FDA classified
- 3 May 2017
- Reported
- 10 May 2017
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Compounded Drugs
Timeline
| 17 Apr 2017 | Recall initiated by company | |
| 3 May 2017 | Classified by FDA | +16 days |
| 10 May 2017 | 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
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Product as listed by the FDA
Zinc Oxide Paste 25%, 500 g, For Prescription Compounding, Fagron Inc.2400 Pilot Knob Rd, St. Paul, MN 55120m NDC 51522-0694-5.
Where it was distributed
Nationwide within US
Questions about this recall
Why was it recalled?
Labeling: Error on Declared Strength: Error is due to an incorrect value in the Drug Facts Panel. The correct strength is displayed on the primary container.
Which lots are affected?
Lot #: 17C01-U07-036096, Exp. 5/1/2020
Where was it sold?
Nationwide within US
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.
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 |