Eye drop recall list: Voluntary recall issued for eye products sold nationwide

WASHINGTON — Thousands of eye care products, including lubricant eye drops and artificial tears, have been voluntarily recalled due to a “manufacturing deviation” found following a U.S. Food and Drug Administration audit. 

AvKARE, a pharmaceutical distributor, said it was notified of the consumer level drug recall by St. Louis-based BRS Analytical Service, LLC for five over-the-counter eye care products. In a urgent notice about the voluntary recall, the company said that the health risk to consumers is unknown, but the “manufacturing deviations” may lead to “products of unacceptable quality, and it is not possible to rule out patient risks resulting from these products.” 

Consumers who have the recalled products are urged to cease use immediately. AvKARE also asks consumers with these products to fill out a recall form on its website and fax the completed form to 931-292-6229 or email it to customerservice@avkare.com. The company will send a Return Authorization Form for consumers to ship the recalled products back to the pharmaceutical distributor and issue full credit, including shipping costs for returns. 

The recalled products were listed on AvKARE’s websites. The affected products, identifiable by their National Drug Code (NDC) numbers and expiration dates, were distributed between May 26, 2023, and April 21, 2025. According to the FDA notice, the recall encompasses thousands of cases, with each case containing 24 cartons of product.

NDC: 50268-043-15
Affected Lots:
0126 (Exp. 10/26/25), 0127 (Exp. 10/30/25), 0128 (Exp. 11/02/25), 0129 (Exp. 11/06/25),
0162 (Exp. 05/09/26), 0163 (Exp. 05/14/26), 0164 (Exp. 05/20/26), 0165 (Exp. 05/23/26),
0166 (Exp. 05/29/26), 0167 (Exp. 06/03/26), 0168 (Exp. 06/06/26), 0169 (Exp. 06/10/26),
0170 (Exp. 06/13/26), 0193 (Exp. 10/07/26), 0194 (Exp. 10/10/26), 0195 (Exp. 10/14/26),
0196 (Exp. 10/17/26), 0197 (Exp. 10/21/26), 0198 (Exp. 10/24/26), 0199 (Exp. 10/30/26)

NDC: 50268-066-15
Affected Lots:
0114 (Exp. 09/04/25), 0115 (Exp. 09/06/25), 0116 (Exp. 09/10/25), 0207 (Exp. 12/05/26)

Cases affected: 32,876 cases (24 cartons per case)

NDC: 50268-068-15
Affected Lots:
0103 (Exp. 04/26/25), 0104 (Exp. 05/03/25), 0108 (Exp. 06/29/25), 0109 (Exp. 07/18/25),
0110 (Exp. 08/17/25), 0111 (Exp. 08/22/25), 0112 (Exp. 08/27/25), 0113 (Exp. 09/18/25),
0125 (Exp. 10/23/25), 0130 (Exp. 11/09/25), 0131 (Exp. 11/14/25), 0132 (Exp. 11/27/25),
0133 (Exp. 11/30/25), 0134 (Exp. 12/05/25), 0135 (Exp. 12/11/25), 0136 (Exp. 12/14/25),
0137 (Exp. 01/02/26), 0139 (Exp. 01/15/26), 0140 (Exp. 01/19/26), 0141 (Exp. 01/25/26),
0151 (Exp. 03/18/26), 0152 (Exp. 03/21/26), 0153 (Exp. 03/25/26), 0154 (Exp. 03/28/26),
0155 (Exp. 04/01/26), 0156 (Exp. 04/08/26), 0157 (Exp. 04/11/26), 0160 (Exp. 04/26/26),
0180 (Exp. 08/08/26), 0181 (Exp. 08/12/26), 0182 (Exp. 08/18/26), 0183 (Exp. 08/21/26),
0184 (Exp. 08/26/26), 0185 (Exp. 09/04/26), 0186 (Exp. 09/09/26), 0187 (Exp. 09/16/26),
0188 (Exp. 09/18/26), 0189 (Exp. 09/21/26), 0190 (Exp. 09/25/26), 0191 (Exp. 09/28/26),
0192 (Exp. 10/02/26), 0208 (Exp. 12/11/26), 0209 (Exp. 12/16/26), 0212 (Exp. 01/15/27),
0213 (Exp. 01/21/27), 0214 (Exp. 01/24/27), 0215 (Exp. 02/02/27), 0216 (Exp. 02/04/27),
0224 (Exp. 03/27/27)

NDC: 50268-126-15
Affected Lots:
0117 (Exp. 09/20/25), 0118 (Exp. 09/25/25), 0119 (Exp. 09/27/25), 0121 (Exp. 10/05/25),
0161 (Exp. 05/01/26), 0171 (Exp. 06/18/26), 0172 (Exp. 06/24/26), 0174 (Exp. 07/01/26),
0175 (Exp. 07/08/26), 0200 (Exp. 11/05/26), 0201 (Exp. 11/10/26), 0202 (Exp. 11/13/26),
0203 (Exp. 11/18/26), 0204 (Exp. 11/21/26), 0205 (Exp. 11/25/26), 0206 (Exp. 12/02/26),
0219 (Exp. 02/24/27), 0221 (Exp. 03/02/27), 0222 (Exp. 03/05/27)

NDC: 50268-678-15
Affected Lots:
0120 (Exp. 10/02/25), 0122 (Exp. 10/09/25), 0123 (Exp. 10/12/25), 0124 (Exp. 10/16/25),
0138 (Exp. 01/08/26), 0142 (Exp. 01/29/26), 0143 (Exp. 02/01/26), 0144 (Exp. 02/07/26),
0145 (Exp. 02/12/26), 0146 (Exp. 02/15/26), 0147 (Exp. 02/21/26), 0148 (Exp. 02/27/26),
0149 (Exp. 03/04/26), 0150 (Exp. 03/11/26), 0158 (Exp. 04/15/26), 0159 (Exp. 04/22/26),
0176 (Exp. 07/24/26), 0177 (Exp. 07/28/26), 0178 (Exp. 07/31/26), 0179 (Exp. 08/05/26)