Gentamicin Ophthalmic Solution Recalled for Sterility Assurance Concerns
Well Care Compounding Pharmacy is recalling Gentamicin 15 mg/ml Ophthalmic Solution due to FDA inspection findings regarding sterility assurance.
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. The hazard involves a lack of assurance of sterility in an ophthalmic product, which poses a significant risk of serious injury or infection, aligning with the 'Severe' criteria for significant injury reports or high-risk defects.
Plain-English summary
Well Care Compounding Pharmacy in Las Vegas, Nevada, is recalling 869 units of Gentamicin 15 mg/ml Ophthalmic Solution. The product is a prescription-only sterile ophthalmic solution distributed in Nevada.
The recall was initiated after an FDA inspection identified Good Manufacturing Practice (GMP) violations. These violations potentially impact the product's quality and sterility, creating a lack of assurance that the product is sterile.
Consumers who have this product should stop using it and contact their healthcare provider or the pharmacy for further instructions.
The recalled product
- Product
- GENTAMICIN 15 MG/ML Ophthalmic Solution, Sterile Droppers, Rx only, Well Care Compounding Pharmacy Las Vegas, NV 89121
- Manufacturer
- Well Care Compounding Pharmacy
- Category
- Drug — Ophthalmic Solution
- Hazard
- Affected units
- 869
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 (10)
- Lot #: 01182016:29@27
- Exp. 02/01/2016
- Lot #: 030720 1631@50
- Exp. 03/21/2016
- Lot #: 03232016:83@6
- Exp 04/06/2016
- Lot #: 03282016:43@11
- Exp. 04/11/2016
- Lot #: 04192016:43@16
- Exp. 05/03/2016
Distribution
Distributed in 1 state:
Part of a larger recall action
This product is one of 51 recalled by Well Care Compounding Pharmacy 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 51 products in this recall →Related recalls
Same manufacturer · Well Care Compounding Pharmacy
See all →- SeverePhosphatidylcholine/Deoxycholic Acid Injection Recalled for Sterility Concerns
FDA (Drugs) · 2016-06-15
- HighFDA Recalls Itraconazole Nasal Spray Due to Sterility Concerns
FDA (Drugs) · 2016-06-15
- ModerateWell Care Compounding Pharmacy Recalls Methylcobalamin Vials for Sterility Concerns
FDA (Drugs) · 2016-06-15
- HighWell Care Compounding Pharmacy Recalls Sterility-Compromised Glutathione Vials
FDA (Drugs) · 2016-06-15
- HighWell Care Compounding Pharmacy Recalls Methylcobalamin Due to Sterility Concerns
FDA (Drugs) · 2016-06-15
Same hazard · sterility
See all →- HighFDA recalls injectable compounded mixture in single-use syringes
FDA (Drugs) · 2026-10-14
- SevereFDA Recalls Tirzepatide 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/Cyanocobalamin 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
- SevereVancomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereMitomycin Ophthalmic Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2015-09-23
- SevereGentamicin Sulfate Irrigation Solution Recalled for Sterility Assurance Concerns
FDA (Drugs) · 2014-11-12
- SevereSpecialty Medicine Compounding Pharmacy Recalls Vancomycin Ophthalmic Solution
FDA (Drugs) · 2014-01-22
- SevereGatifloxacin Ophthalmic Drops Recalled for Lack of Sterility Assurance
FDA (Drugs) · 2014-01-22
- SevereGentamycin Injection Recalled Due to Sterility Assurance Concerns
FDA (Drugs) · 2014-03-12