CLASS II ONGOING Drug recall · Reported 10 Dec 2025 · FDA Enforcement Report
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant recalled
Blossom Pharmaceuticals is recalling Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, distributed nationwide in the US. The recall was initiated on 31 Oct 2025 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-0212-2026
- FDA event ID
- 97935
- Recalling firm
- Blossom Pharmaceuticals, Bardej, Goa
- Brand
- Zinc Oxide 20%
- Manufacturer
- Trifecta Pharmaceuticals USA
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 31 Oct 2025
- FDA classified
- 2 Dec 2025
- Reported
- 10 Dec 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Creams, Ointments & Gels
Timeline
| 31 Oct 2025 | Recall initiated by company | |
| 2 Dec 2025 | Classified by FDA | +32 days |
| 10 Dec 2025 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant, Net Wt. 2 oz (56.7 g), Distributed by: Trifecta Pharmaceuticals USA 101 NE, Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, NDC 69396-086-02.
Where it was distributed
USA Nationwide
Questions about this recall
Is Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant recalled?
Yes. Blossom Pharmaceuticals recalled Globe Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant on 31 Oct 2025. The recall is Class II and its status is Ongoing. Recall number D-0212-2026.
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot #: A502404, Exp. Date 2/27; A502405, Exp. Date 2/27; AS02502, Exp. Date 2/28.
Where was it sold?
USA Nationwide
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 Blossom Pharmaceuticals
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | WeCare, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsZinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Dynagel, Moisturizing Wound Hydrogel recalled by Blossom Pharmaceuticals | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Globe Clotrimazole Cream USP, 1 % Antifungal Cream recalledClotrimazole | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nivagen, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsNivagen Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Lanashield Skin Barrier, Manfuactured recalled | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
Other Zinc Oxide recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Nivagen, Zinc Oxide Ointment recalled by Blossom PharmaceuticalsNivagen Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 % recalledNivagen Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Dynashield cream recalled by Blossom PharmaceuticalsDynashield | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Dynashield Skin Protectant recalled by Blossom PharmaceuticalsDynashield | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Nivagen Pharmaceuticals, Zinc Oxide Ointment recalledNivagen Zinc Oxide | Blossom Pharmaceuticals | Manufacturing (CGMP) Deviations | Nationwide |