CLASS II Drug recall · Reported 7 Oct 2020 · FDA Enforcement Report
Boric Acid Vaginal Suppositories recalled by pH-D Feminine Health
pH-D Feminine Health is recalling Boric Acid Vaginal Suppositories, 24 vaginal suppositories per, 600 mg each, pH-D, distributed nationwide in the US. The recall was initiated on 2 Sep 2020 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-1627-2020
- FDA event ID
- 86405
- Recalling firm
- pH-D Feminine Health, Madison, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 Sep 2020
- FDA classified
- 30 Sep 2020
- Reported
- 7 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Other Reasons
Timeline
| 2 Sep 2020 | Recall initiated by company | |
| 30 Sep 2020 | Classified by FDA | +28 days |
| 7 Oct 2020 | 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
Marketed without an Approved NDA/ANDA.
Product as listed by the FDA
pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositories per box, 600 mg each, pH-D Feminine Health, LLC Madison, TN 37115, UPC Code: 3 49597 00044 5.
Where it was distributed
Nationwide in the U.S.
Questions about this recall
Why was it recalled?
Marketed without an Approved NDA/ANDA.
Which lots are affected?
Lot #: a) 2PA20021, 2PA20061; b) D-160, D-155, D-162; c) 7PA20071.
Where was it sold?
Nationwide in the U.S.
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 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.