Agency classClass IIOur severity:Moderate FDA (Drugs)·D-0887-2021·Announced 2021-10-06

ZTE 1013 Formula Antimicrobial Homeopathic Product Recall

Washington Homeopathic Products is recalling ZTE 1013 Formula Antimicrobial (1000 ml, Lot # 25738) distributed nationwide because testing identified out-of-specification results during identification analysis.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard is a testing specification failure rather than a known contamination or safety defect. The source text does not indicate that use of the product has caused harm, making this a precautionary or quality-control-driven recall.

Plain-English summary

Washington Homeopathic Products, Inc. is recalling ZTE 1013 Formula Antimicrobial - F&M (Contents 1000 ml) manufactured for Optimal Health Dimensions. The product contains multiple homeopathic remedies including Bryonia Alba, Antimonium Crudum, Iodium, and other ingredients at various potencies, plus 20% dilution alcohol.

The recall was initiated because out-of-specification test results were obtained during identification testing using HPTLC (High-Performance Thin Layer Chromatography) analysis. This indicates the product did not meet established testing standards for identity verification.

The affected product is Lot # 25738 with no expiry date listed. Distribution was nationwide in the USA. Consumers who have purchased this product should stop using it.

Consumers with questions about this recall should contact the recalling manufacturer directly.

The recalled product

Product: ZTE 1013 Formula Antimicrobial - F&M , Contents 1000 ml, REMEDY: Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberus Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Chromium Sulphuricum 10X, Manganum…
Manufacturer: Washington Homeopathic Products, Inc.
Category: Drug — Homeopathic
Hazard: identification-test-failure
out-of-specification

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

Lot # 25738
no expiry date

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 39 recalled by Washington Homeopathic Products, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 39 products in this recall →

Same manufacturer · Washington Homeopathic Products, Inc.

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Same hazard · identification test failure