CLASS II Drug recall · Reported 6 Oct 2021 · FDA Enforcement Report
Althaea Officinalis 4X, Iritable Bladder* packaged as recalled
Washington Homeopathic Products is recalling Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP, 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-0863-2021
- 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
- Packaging Defects
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.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP Homeopathic Medicine, Washington Homeopathic Products, 260 JR Hawvermale Way, Berkeley Springs, WV 25411.
Where it was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP recalled?
Yes. Washington Homeopathic Products recalled Althaea Officinalis 4X, Iritable Bladder* packaged as Sucrose/Lactose Pills, 4 Dram, WHP on 20 Aug 2021. The recall is Class II and its status is Terminated. Recall number D-0863-2021.
Why was it recalled?
Out-of-specification test results obtained for identification testing based on HPTLC analysis.
Which lots are affected?
Lot # 29377, Exp 8/17/2026
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 |