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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Various Topical Creams and Enemas Recalled for Manufacturing Violations

Agency Publication Date: December 2, 2025
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Summary

Blossom Pharmaceuticals is recalling 133,410 units of various over-the-counter drug products, including zinc oxide ointments, antifungal creams, skin barriers, and enemas. The recall was initiated due to deviations from Current Good Manufacturing Practice (cGMP) regulations, which means the facility's quality and safety standards did not meet FDA requirements. These products are sold under several brand names including Dynarex, WeCare, Nivagen, and Globe.

Risk

Failure to follow manufacturing quality standards can result in products that are contaminated, ineffective, or contain incorrect ingredient levels. This poses a health risk to consumers using these products for skin protection, wound care, or as laxatives.

What You Should Do

  1. Check your product packaging for the brand name (Dynarex, WeCare, Nivagen, or Globe) and the specific product type.
  2. Check the lot number and expiration date printed on your product's container or carton. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Blossom Pharmaceuticals for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Lanashield Skin Barrier (4 oz.)by Dynarex
UPC Codes:
616784126319
Lot Numbers:
A162301 (Exp. Date 9/26)
A162401 (Exp. Date 4/27)
A162202 (Exp. Date 11/25)
Product: Dynashield Skin Protectant (16 oz)by Dynarex
Lot Numbers:
A092334 (Exp. Date 6/26)
A092421 (Exp. Date 7/27)
NDC:
67777-407-04
Product: Wecare Enema (4.5 Fl Oz)by WeCare
Lot Numbers:
A022310 (Exp. Date 2/26)
A022335 (Exp. Date 10/26)
A022406 (Exp Date 12/27)
A022505 (Exp Date 12/27)
NDC:
67777-402-01
Product: Dynagel Moisturizing Wound Hydrogel (3 oz)by Dynarex
UPC Codes:
061784128016
Lot Numbers:
A322301 (Exp. Date 7/26)
A322302 (Exp. Date 8/26)
Product: WeCare Zinc Oxide Ointment (15 oz)by WeCare
Lot Numbers:
A062434 (Exp. Date 6/27)
A062449 (Exp. Date 7/27)
NDC:
67777-223-05
Product: Nivagen Pharmaceuticals Zinc Oxide Ointment USP (15 oz)by Nivagen
Variants: Zinc Oxide 20%
Lot Numbers:
A352318
NDC:
75834-170-15
Product: Dynashield Cream (4 oz)by Dynarex
Lot Numbers:
A092421 (Exp. Date 7/27)
A092340 (Exp. Date 10/26)
A092346 (Exp. Date 11/26)
NDC:
67777-407-03
Product: Nivagen Zinc Oxide Ointment (1 oz)by Nivagen
Lot Numbers:
A352405
NDC:
75834-170-01
Product: Nivagen Zinc Oxide Ointment USP (1 oz)by Nivagen
Variants: Zinc Oxide 20%
Lot Numbers:
A352505
NDC:
75834-170-02
Product: Globe Clotrimazole Cream USP 1% (1 oz)by Globe
Lot Numbers:
A472408
NDC:
69396-087-01
Product: Globe Clotrimazole Cream USP 1% (5 oz)by Globe
Lot Numbers:
A472418
NDC:
69396-087-55
Product: Globe Zinc Oxide Ointment USP (2 oz)by Globe
Variants: Zinc Oxide 20%
Lot Numbers:
A502404 (Exp. Date 2/27)
A502405 (Exp. Date 2/27)
AS02502 (Exp. Date 2/28)
NDC:
69396-086-02
Product: Wecare Calasoothe (4 oz)by WeCare
Lot Numbers:
A482305
NDC:
67777-234-04

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 97935
Status: Active
Manufacturer: Blossom Pharmaceuticals
Sold By: Dynarex Corporation; Nivagen Pharmaceuticals, Inc.; Trifecta Pharmaceuticals USA
Manufactured In: India
Units Affected: 13 products (9600 containers; 1560 containers; 18912 containers; 8184 bottles; 2592 bottles; 912 containers; 7944 containers; 13536 containers; 7920 bottles; 12150 bottles; 14700 bottles; 33000 containers; 2400 containers)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.