The Recall Desk
ModerateFDA (Drugs)·D-0888-2021·Announced 2021-10-06

ZTE 1015 Formula Homeopathic Product Recall for Out-of-Specification Test Results

Washington Homeopathic Products is recalling ZTE 1015 Formula due to out-of-specification test results from identification testing. The product failed HPTLC analysis.

What this means for you

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 involving out-of-specification test results for a homeopathic product. The source text does not report any illnesses, injuries, or confirmed harm, making this a precautionary/quality-control issue rather than an active safety threat. Class II recalls without reported illness or injury typically fall in the Moderate range.

Plain-English summary

Washington Homeopathic Products, Inc. is recalling ZTE 1015 Formula, a 1000 ml homeopathic product containing multiple ingredients including Argentum Nitricum, Rhus Toxicodendron, Aurum Metallicum, Iris Versicolor, Lycopodium Clavatum, Zincum Muriaticum, Chromium Sulphuricum, and Manganum Metallicum in dilution alcohol. The product is marketed for manufacturing use only.

The recall was initiated because the product failed identification testing using HPTLC (high-performance thin-layer chromatography) analysis, with test results falling outside of acceptable specifications. Lot #25739 was distributed nationwide in the USA.

The FDA classified this as a Class II recall. Consumers who have received this product should cease use and contact Washington Homeopathic Products, Inc. for further instructions regarding the recalled product.

The recalled product

Product
ZTE 1015 Formula, Contents 1000 ml, For Manufacturing Use only, REMEDY: Argentum Nitricum 10X, Rhus Toxicodendron 10X, Aurum Metallicum 10X, Iris Versicolor 10X, Lycopodium Clavatum 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Dilution Alcohol 2
Manufacturer
Washington Homeopathic Products, Inc.
Hazard
  • out-of-specification
  • failed-identification-testing

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 # 25739
  • no expiry date

Distribution

Distributed nationwide across the United States.