Class II · Moderate risk
Polyvinyl Alcohol Ophthalmic Solution 1.4%
cGMP deviations and lack of assurance of sterility.
Lubricant Eye Drops Solution
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
cGMP deviations and lack of assurance of sterility.
Cause type: Sterility / contamination
A product that must be sterile could not be assured sterile, or was contaminated. A top reason for injectables, eye drops and IV products - loss of sterility assurance can lead to serious infections. All sterility / contamination recalls.
What was recalled
Lubricant Eye Drops Solution, Polyethylene Glycol 400 0.4% Eye Lubricant, Propylene Glycol 0.3% Eye Lubricant, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-126-15.
Affected NDC
50268-0126-15
Compare with the code on your package — it is the most precise check available.
Category: Eye Drops & Ophthalmic
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Lubricant Eye Drops Solution polyethylene glycol 400 and Propylene Glycol NDC 50268-0126 |
POLYETHYLENE GLYCOL 400 4 mg/mL; PROPYLENE GLYCOL 3 mg/mL | Solution Ophthalmic |
AvPAK | OTC |
- Recalling firm
- BRS Analytical Services, LLC
- Origin
- MO, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0407-2025 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall.
Other recalls by BRS Analytical Services, LLC
All 2025 recalls
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Carboxymethylcellulose Sodium Ophthalmic Gel 1%
cGMP deviations and lack of assurance of sterility.
Class II · Moderate risk
Artificial Tears Ophthalmic Solution
cGMP deviations and lack of assurance of sterility.
Other sterility / contamination recalls from 2025
All sterility / contamination recalls
Class II · Moderate risk
BioGlo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Bio Glo Fluorescein Sodium Ophthalmic Strips USP
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
CHNaO Fluorescein Sodium Ophthalmic Strips
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
Class II · Moderate risk
Vista Gonio Eye Lubricant
Lack of Assurance of Sterility: Products have not been manufactured in conformance with current good manufacturing practices.
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