Unrated Drug recall · FDA · Published October 31, 2025

Globe Zinc Oxide Ointment Recall: cGMP Deviations

Blossom Pharmaceuticals recalls Globe Zinc Oxide Ointment distributed by Trifecta due to cGMP deviations. Check lot numbers A502404, A502405, AS02502.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0212-2026Drug Globe ›

Recall notice

cGMP deviations

Take action

Contact the company

Recalling firmBlossom PharmaceuticalsPlot No. 21/22 Bardez Blossom Pharmaceuticals Karaswada-Tivim · Bardej, Goa, India

✎ GovInfoNow plain-language explainer

Blossom Pharmaceuticals is recalling Globe Zinc Oxide Ointment USP (Zinc Oxide 20% Skin Protectant) because of current Good Manufacturing Practice (cGMP) deviations. The product was distributed nationwide by Trifecta Pharmaceuticals USA. The specific nature of the manufacturing deviations and any resulting health risks are not detailed in the record. Read more at govinfonow.com/recall/31645-globe-zinc-oxide-ointment-recall-cgmp-deviations.

Source Summary by GovInfoNow · govinfonow.com/recall/31645-globe-zinc-oxide-ointment-recall-cgmp-deviations · Updated October 9, 2026 · FDA enforcement record: FDA #D-0212-2026

Cite this page

“Globe Zinc Oxide Ointment Recall: cGMP Deviations.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/31645-globe-zinc-oxide-ointment-recall-cgmp-deviations. Based on FDA recall #D-0212-2026 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0212-2026%22&limit=1).

The FDA announced on Oct. 31, 2025, that Blossom Pharmaceuticals is recalling Globe Zinc Oxide Ointment USP due to current good manufacturing practice (cGMP) deviations. The voluntary Class II recall affects 33,000 containers distributed nationwide.

How to tell if you have it

Brand: Globe
Product: Zinc Oxide Ointment USP
NDC: 69396-086-02
Lot #: A502404, Exp. Date 2/27
Lot #: A502405, Exp. Date 2/27
Lot #: AS02502, Exp. Date 2/28

The hazard

The recall is due to cGMP deviations. According to FDA's FAERS database, there are 1,944 adverse-event reports naming this product, including 1,654 marked serious and 204 listing a death; these are unverified reports not findings about this specific recall.

Context

GovInfoNow's records show other recent recalls of similar products include Wells Pharma Fentanyl Citrate Injectable Solution Recall due to CGMP deviations on April 1, 2026, and Ajanta Pharma Fenofibrate Capsules Recall due to CGMP deviations risk on May 28, 2026.

How to tell if you have this one

Check your tube for the brand 'Globe' and the description 'Zinc Oxide Ointment USP Zinc Oxide 20% Skin Protectant'. Verify the Net Wt. is 2 oz (56.7 g) and the NDC is 69396-086-02. Look for one of these Lot numbers on the packaging: A502404, A502405, or AS02502.

Brand
Globe
Category
Drug

FDA recall event · 13 products

All 13 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

Classification
Class II
Status
Ongoing
Distribution
USA Nationwide

Recall number	Product, codes & lots	Quantity	NDC
D-0201-2026	Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.; Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.	9600 containers	—
D-0202-2026	Dynashield Skin Protectant, Net Wt. 16 oz (453.6 g), Manufactured for: Dyrnarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, USA, Made in India, NDC 67777-407-04.; Lot #: A092334, Exp. Date 6/26 & A092421, Exp. Date 7/27	1560 containers	67777-407-01, 67777-407-02, 67777-407-03, 67777-407-10, 67777-407-04, 67777-407-11, 67777-407-12, 67777-407-13
D-0203-2026	Wecare Enema, 4.5 Fl Oz/133mL, Manufactured for: Dynarex Corporation, 11 Dynarex Corporation, MIddletown, NY 10941 USA, Made in India, NDC 67777-402-01.; Lot #: A022310, Exp. Date 2/26; A022335, Exp. Date 10/26; A022406, Exp Date 12/27 & A022505, Exp Date 12/27	18912 containers	67777-402-01, 67777-402-02
D-0204-2026	Dynagel, Moisturizing Wound Hydrogel, Net Wt. 3oz (84.7 g), Manufactured for: Dynarex Corporation, 16 Glenshaw Street, Orangeburg, NY 10962, UPC 61784128016.; Lot #: A322301, Exp. Date 7/26 & A322302, Exp. Date 8/26	8184 bottles	—
D-0205-2026	WeCare, Zinc Oxide Ointment, Net Wt. 15 oz/425 g, Manuactured for: Dynarex Corporation, 11 Dynarex Drive, Middletown, NY 10941, Made in India, NDC 67777-223-05.; Lot #: A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27	2592 bottles	67777-223-01, 67777-223-11, 67777-223-02, 67777-223-03, 67777-223-13, 67777-223-04, 67777-223-05, 67777-223-06
D-0206-2026	Nivagen Pharmaceuticals, Zinc Oxide Ointment USP, Zinc Oxide 20% Skin Protectant, Net Wt. 15 oz (425g), Made in India, Manufactured for: Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, NDC 75834-170-15.; Lot #: A352318	912 containers	75834-170-01, 75834-170-02, 75834-170-15
D-0207-2026	Dynashield, 4 oz cream (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10852, USA, Made in India, NDC 67777-407-03.; Lot #: A092421, Exp. Date 7/27, A092340, Exp. Date 10/26 & A092346, Exp. Date 11/26.	7944 containers	67777-407-01, 67777-407-02, 67777-407-03, 67777-407-10, 67777-407-04, 67777-407-11, 67777-407-12, 67777-407-13
D-0208-2026	Nivagen, Zinc Oxide Ointment, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA Made in India, NDC 75834-170-01.; Lot #: A352405	13536 containers	75834-170-01, 75834-170-02, 75834-170-15
D-0209-2026	Nivagen, Zinc Oxide Ointment USP, Zinc Oxide 20 %, Net Wt. 1 oz. (28.4g), Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827, USA, Made in India, NDC 75834-170-02.; Lot #: A352505	7920 bottles	75834-170-01, 75834-170-02, 75834-170-15
D-0210-2026	Globe Clotrimazole Cream, USP, 1 %, Net Wt. 1 oz (28.4g), Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301 USA, Made in India, NDC 69396-087-01.; Lot #: A472408	12150 bottles	69396-087-01, 69396-087-55
D-0211-2026	Globe Clotrimazole Cream USP, 1 % Antifungal Cream, Net Wt., 5 oz. (142 g, Distributed by: Trifecta Pharmaceuticals USA, 101 NE Third Avenue, Suite 1500, Ft. Lauderdale, FL 33301, USA, NDC 69396-087-55.; Lot #: A472418	14700 bottles	69396-087-01, 69396-087-55
D-0212-2026	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.; Lot #: A502404, Exp. Date 2/27; A502405, Exp. Date 2/27; AS02502, Exp. Date 2/28.	33000 containers	69396-086-02
D-0213-2026	Wecare Calasoothe, Net wt. 4 oz (113 g), Manufactured for: Dynarex Corporation, 10 Glenshaw Street, Orangeburg, NY 10962, NDC 67777-234-04.; Lot #: A482305	2400 containers	67777-234-02, 67777-234-01, 67777-234-04, 67777-234-03

Based on the official FDA remedy

What to do — step by step

Check Your Product
Verify if your Globe Zinc Oxide Ointment matches the recalled lot numbers (A502404, A502405, AS02502) and expiration dates (2/27 or 2/28).
Contact Distributor
Reach out to Trifecta Pharmaceuticals USA for further instructions on the remedy, as specific return or disposal steps are not provided in the record.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA published this recall 40 days after the firm started it.

Oct 31, 2025Firm started the recall
Dec 2, 2025FDA classified it Class II
Dec 10, 2025Published in FDA’s Enforcement Report

Dates from the agency record only; steps without a date are left out.

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Link to this recall

<a href="https://govinfonow.com/recall/31645-globe-zinc-oxide-ointment-recall-cgmp-deviations">Globe Zinc Oxide Ointment Recall: cGMP Deviations (GovInfoNow)</a>

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

Official source: FDA Recall #D-0212-2026 (October 31, 2025) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0212-2026 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 9, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.