Health Innovations Pharmacy Recalls EDTA 3% Eye Drops for Sterility Concerns
Health Innovations Pharmacy is recalling EDTA 3% Eye Drops due to inspection findings regarding 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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II. According to the rubric, FDA Class II recalls involving significant risks such as sterility issues in medical products are classified as Severe (Score 4), particularly when specific injury reports are not explicitly detailed but the defect is structural/quality-based.
Plain-English summary
Health Innovations Pharmacy, Inc. is recalling EDTA 3% Eye Drops. The recall was initiated following recent inspection observations associated with certain quality control procedures. These observations present a risk to the sterility and quality assurance of the product.
The recall covers all lots of the product. The distribution pattern is listed as NC (North Carolina). The source text does not specify the exact number of units affected or specific dates of distribution.
Consumers who have purchased these eye drops should stop using them and contact Health Innovations Pharmacy at (910) 246-5155 or visit their location at 295 Pinehurst Ave, Southern Pines, NC 28387 for further instructions.
The recalled product
- Product
- EDTA 3% Eye Drops, Health Innov Pharmacy, 295 Pinehurst Ave, Southern Pines, NC 28387, (910) 246-5155
- Manufacturer
- Health Innovations Pharmacy, Inc
- Category
- Drug — Ophthalmic
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
See all →- SevereK.C. Pharmaceuticals Recalls Target Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tri-MIX Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Semaglutide/Cyanocobalamin Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide Injectable Due to Sterility Concerns
FDA (Drugs) · 2026-10-14
- SevereK.C. Pharmaceuticals Recalls Leader Advanced Relief Eye Drops for Sterility Concerns
FDA (Drugs) · 2026-10-14
Similar recalls
- SevereNatures Pharmacy Recalls EDTA 3% Ophthalmic Due to Sterility Concerns
FDA (Drugs) · 2014-03-12
- HighPharmacy Innovations Cyclosporine Eye Drops Recalled for Sterility Defect
FDA (Drugs) · 2023-02-01
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Concerns
FDA (Drugs) · 2026-09-30
- SevereClear Eyes Redness Relief Eye Drops Recalled for Sterility Assurance Issues
FDA (Drugs) · 2026-09-30
- SevereMedical Center Pharmacy Recalls Mitomycin Eye Drops Due to Sterility Concerns
FDA (Drugs) · 2020-04-08
- SevereNatures Pharmacy Recalls 5-Fluorouracil Eye Drops for Sterility Concerns
FDA (Drugs) · 2014-03-12