Artificial Tears Ophthalmic Solution recall: Sterility Concern
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.
Why was Artificial Tears Ophthalmic Solution recalled?
cGMP deviations and lack of assurance of sterility.
What should I do if I have this product?
The recall is ongoing. Follow the firm and FDA instructions.
What to do with a recalled product: refunds, receipts, safe disposal and how to report a problem.
Is my product affected?
Compare the item in your hand with every identifier below from the official FDA record. Only products that match the listed product and lot, UPC or model codes are part of this recall.
Which lot codes, UPCs or models are affected?
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 10/07/26; Lot 194, exp 10/10/26; Lot 195, exp 10/14/26; Lot 196, exp 10/17/26; Lot 197, exp 10/21/26; Lot 198, exp 10/24/26; Lot 199, exp 10/30/26.
- 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 firm
- BRS Analytical Services, LLC
- Quantity
- 13,872 cases (24 cartons per case)
- Distribution
- Nationwide in the USA
- Recall date
- May 14, 2025
- Classification
- Class II
- Status
- Ongoing
- Agency
- FDA (drug)