FDA Drugs recall ·
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops… recall
- Recall number
- D-0408-2025
- Date
- (initiated April 23, 2025)
- Company / brand
- BRS Analytical Services, LLC
11697 Lakeside Crossing Ct, Saint Louis, MO, United States - Category
- Drugs › Class II
- Classification
- Class II
- Status
- Ongoing
- Units affected
- 14,333 cases (24 cartons per case)
- Hazard tags
- Sterility Manufacturing practices (cGMP)
- Initiated by
- Voluntary: Firm initiated
Read the official FDA notice ↗
Product
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Lubricant Eye Drops, Moisturizing, Sterile, 0.5 FL OZ (15mL) per dropper bottle, Distributed by: AvKARE, Pulaski, TN 38478, NDC: 50268-678-15.
Why was it recalled?
cGMP deviations and lack of assurance of sterility.
What should you do?
FDA enforcement reports do not list a consumer remedy. Check the product codes below against what you have; if it matches, stop using it and follow the instructions in the firm's or FDA's official notice, or contact the company. If you have health concerns, contact your healthcare provider.
Product codes & lot numbers
Lot, expiry: Lot 120, exp 10/02/25; Lot 122, exp 10/09/25; Lot 123, exp 10/12/25; Lot 124, exp 10/16/25; Lot 138, exp 1/08/26; Lot 142, exp 1/29/26; Lot 143, exp 2/01/26; Lot 144, exp 2/07/26; Lot 145, exp 2/12/26; Lot 146, exp 2/15/26; Lot 147, exp 2/21/26; Lot 148, exp 2/27/26; Lot 149, exp 3/04/26; Lot 150, exp 3/11/26; Lot 158, exp 4/15/26; Lot 159, exp 4/22/26; Lot 176, exp 7/24/26; Lot 177, exp 7/28/26; Lot 178, exp 7/31/26; Lot 179, exp 8/05/26.
Distribution
Nationwide in the USA
What does Class II mean?
Class II means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious harm is remote.
Source: FDA (drugs), recall D-0408-2025. Official notice. Republished from public data; RecallFlag is not affiliated with the FDA.