CLASS II Drug recall · Reported 6 Oct 2021 · FDA Enforcement Report
Zte-1035 Formula, Antimicrobial Combination, Contents recalled
Washington Homeopathic Products is recalling Zte-1035 Formula, Antimicrobial Combination, Contents, Remedy: Arsenicum Album 10X, distributed nationwide in the US. The recall was initiated on 20 Aug 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0886-2021
- FDA event ID
- 88528
- Recalling firm
- Washington Homeopathic Products, Berkeley Springs, WV
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 20 Aug 2021
- FDA classified
- 29 Sep 2021
- Reported
- 6 Oct 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Lead & Heavy Metals
Timeline
| 20 Aug 2021 | Recall initiated by company | |
| 29 Sep 2021 | Classified by FDA | +40 days |
| 6 Oct 2021 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Lead and other heavy metals accumulate in the body. Children are most at risk; even low levels can affect development.
Product as listed by the FDA
ZTE-1035 Formula, Antimicrobial Combination, Contents 1006 ml, REMEDY: Arsenicum Album 10X, Baptista Tinctoria 10X, Phosphorus 10X, Arnica Montana 10X, Bryonia Alba 10X, Antimonium Crudum 10X, Iodium 10X, Lycopodium Clavatum 10X, Pulsatilla 10X, Berberis Vulgaris 10X, Glycyrrhiza Clabra 10X, Condurango 10X, Ginco Biloba 10X, Zincum Muriaticum 13X, Chromium Sulphuricum 10X, Manganum Metallicum 10X, Alfalfa 3X, Dilution Alcohol 20%, Manufactured by: Washington Homeopathic Products 260 JR Hawvernale Way, Berkeley Springs, WV, 225411, Manufactured for Optimal Health Dimensions, Washington Homeopathic Products, Inc. 260 JR Hawvernale Way, Berkeley Springs, WV, 25411,
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Zte-1035 Formula, Antimicrobial Combination, Contents, Remedy: Arsenicum Album 10X recalled?
Yes. Washington Homeopathic Products recalled Zte-1035 Formula, Antimicrobial Combination, Contents, Remedy: Arsenicum Album 10X on 20 Aug 2021. The recall is Class II and its status is Terminated. Recall number D-0886-2021.
Why was it recalled?
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Which lots are affected?
Lot # 25697, no expiry date
Where was it sold?
Distributed Nationwide in the USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Washington Homeopathic Products
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Complete 30C/200C Homeopathic Kit, Contains recalled | Washington Homeopathic Products | Labeling Errors | Nationwide |
| Drug | CLASS II | Candida Parapsilosis, Potency: 14X, 15X, 16X, 20X, 28X, 30X recalled | Washington Homeopathic Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Influenzinum, Potency: 9X, 10X, 12X, 15X, 25X, 30X, 200C recalled | Washington Homeopathic Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Candida Albicans, Potency: 9C, 10C, 12C, 13C, 14C 15C 16C recalled | Washington Homeopathic Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Pertussinum, Potency: 19C, 30C, 200C, 1M, Liquid Pellets recalled | Washington Homeopathic Products | Potency & Assay | Nationwide |