Artificial Tears Ophthalmic Solution recall
FDA recall D-0404-2025 · initiated Apr 23, 2025
BRS Analytical Services, LLC recalled Artificial Tears Ophthalmic Solution in Apr 2025 — an FDA Class II recall (D-0404-2025) because cGMP deviations and lack of assurance of sterility.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
cGMP deviations and lack of assurance of sterility.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 13,872 cases (24 cartons per case)
Details
- Product
- Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3% (Eye Lubricants) Lubricant Eye Drops, STERILE, 0.5 FL OZ (15 mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-043-15.
- Recalling company
- BRS Analytical Services, LLC
- Classification
- Class II
- Status
- Ongoing
- Type
- Voluntary: Firm initiated
- Distribution
- Nationwide in the USA
- Initiated
- Apr 23, 2025
- FDA report date
- May 14, 2025
Frequently asked
- Was Artificial Tears Ophthalmic Solution recalled?
- BRS Analytical Services, LLC recalled Artificial Tears Ophthalmic Solution in Apr 2025 — an FDA Class II recall (D-0404-2025) because cGMP deviations and lack of assurance of sterility. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Artificial Tears Ophthalmic Solution recalled?
- Per the FDA enforcement record, the reason for recall D-0404-2025 was: cGMP deviations and lack of assurance of sterility.
- Is a recalled Artificial Tears Ophthalmic Solution dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Artificial Tears Ophthalmic Solution are affected?
- Distributed: Nationwide in the USA. The recall covers these lots — Lot, expiry: Lot 126, exp 10/26/25; Lot 127, exp 10/30/25; Lot 128, exp 11/02/25; Lot 129, exp 11/06/25; Lot 162, exp 5/09/26; Lot 163, exp 5/14/26; Lot 164, exp 5/20/26; Lot 165, exp 5/23/26; Lot 166, exp 5/29/26; Lot 167, exp 6/03/26; Lot 168, exp 6/06/26; Lot 169, exp 6/10/26; Lot 170, exp 6/13/26; Lot 193, exp 10/0…. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0404-2025.