Boric Acid Vaginal Capsules Recalled for Sterility and Stability Concerns
Health Innovations Pharmacy is recalling Boric Acid Vaginal Capsules due to quality control issues affecting sterility and stability data.
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 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall involves a risk-of-harm product (sterility failure) where injury has not yet been reported, fitting the High severity criteria.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling Boric Acid Vaginal Capsules. The recall was initiated because recent inspection observations identified deficiencies in certain quality control procedures. These deficiencies present a risk to the sterility and quality assurance of the product, as stability data does not support the stated expiry dates.
The recall covers all lots of the product. Distribution was limited to North Carolina. The source text does not specify the number of units affected or report any illnesses or injuries associated with the use of these capsules.
Consumers who have purchased these capsules should stop using them and contact Health Innovations Pharmacy for further instructions or a refund.
The recalled product
- Product
- Boric Acid Vaginal Capsules, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Pharmaceutical
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 (1)
- All lots
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 65 recalled by Health Innovations Pharmacy, 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 65 products in this recall →Related recalls
Same manufacturer · Health Innovations Pharmacy, Inc
See all →- ModerateCarvedilol 1.25 mg/mL Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
- HighProgest Cream Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
- HighHealth Innovations Pharmacy Recalls Phospholine Iodide Eye Drops
FDA (Drugs) · 2015-05-20
- HighNortriptyline Suspension Recalled for Sterility and Stability Concerns
FDA (Drugs) · 2015-05-20
- HighHealth Innovations Pharmacy Recalls Naltrexone Capsules Due to Sterility Concerns
FDA (Drugs) · 2015-05-20
Same hazard · sterility failure
See all →- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereAvKare Carboxymethylcellulose Sodium Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereROHTO DIGI-EYE Eye Drops Recalled Over Sterility Assurance Gap
FDA (Drugs) · 2026-07-29
- HighROHTO DRY-AID Eye Drops Recalled Due to Sterility Concerns
FDA (Drugs) · 2026-07-29
- SevereOne-Piece Introducer Tray kits recalled for sterility failure
FDA (Devices) · 2026-07-22
Similar recalls
- SevereNatures Pharmacy Recalls Folic Acid Injections Due to Sterility Concerns
FDA (Drugs) · 2014-03-12
- HighBoric Acid Vaginal Suppositories Recalled Due to Manufacturing Control Defects
FDA (Drugs) · 2022-07-13
- HighBoric Acid 600 mg Capsules Recalled for Insanitary Manufacturing Conditions
FDA (Drugs) · 2022-07-13
- SevereCyanocobalamin Injection Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12
- HighInjectable Hydroxocobalamin Recalled Due to Sterility Assurance Failure
FDA (Drugs) · 2023-02-01
- SevereBeacon Hill Medical Pharmacy Recalls Ascorbic Acid Injectable Due to Sterility Concerns
FDA (Drugs) · 2013-09-18