openFDA Drug Enforcement
Report-date coverage
June 20, 2012–July 08, 2026
Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.
Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.
Product dates, classifications, firms, and source wording remain attached to their individual rows.
Opening this dossier never hides products that did not match a prior timeline filter.
drug · product 1 of 13
Lanashield Skin Barrier, 4 oz. (113 g), Manfuactured for: Dynarex Corporation, 10 Gleshaw Street, Orangeburg, NY 10962 USA, Made in India, UPC 616784126319.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviations
Code information
Lot #: A162301, Exp. Date 9/26; A162401, Exp. Date 4/27 & A162202, Exp. Date 11/25.
Distribution pattern
USA Nationwide
drug · product 2 of 13
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.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviations
Code information
Lot #: A092334, Exp. Date 6/26 & A092421, Exp. Date 7/27
Distribution pattern
USA Nationwide
drug · product 3 of 13
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.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviations
Code information
Lot #: A322301, Exp. Date 7/26 & A322302, Exp. Date 8/26
Distribution pattern
USA Nationwide
drug · product 5 of 13
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.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviations
Code information
Lot #: A062434, Exp. Date 6/27 & A062449, Exp. Date 7/27
Distribution pattern
USA Nationwide
drug · product 6 of 13
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.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviations
Code information
Lot #: A352405
Distribution pattern
USA Nationwide
drug · product 9 of 13
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.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviations
Code information
Lot #: A352505
Distribution pattern
USA Nationwide
drug · product 10 of 13
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.
Manufacturing or process controlreason.manufacturing_process_control · v1.0.0
cGMP deviations
These labels are deterministic app interpretations, not FDA categories.
Inspect official wording and provenance
Reason for recall
cGMP deviations
Code information
Lot #: A472408
Distribution pattern
USA Nationwide
drug · product 11 of 13
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.
