Medications & Supplements/Over-the-Counter

AvKARE Lubricant Eye Drops Recalled for Potential Lack of Sterility

Agency Publication Date: May 6, 2025

Summary

BRS Analytical Services, LLC is recalling approximately 75,795 units of several types of AvKARE brand eye lubricants, including Artificial Tears (dextran 70.01%/glycerin 0.2%/hypromellose 0.3%) and various formulations of carboxymethylcellulose sodium, polyethylene glycol, and polyvinyl alcohol. The recall was initiated due to manufacturing violations and a lack of assurance that the products are sterile. Using non-sterile eye drops can lead to serious eye infections that may cause vision loss. These products were sold in 0.5 FL OZ dropper bottles and were distributed nationwide across the United States.

Risk

Products intended for use in the eyes that are not sterile pose a significant risk of infection, as bacteria or other contaminants can be introduced directly to the eye. While no specific injuries have been reported, the lack of sterility assurance means the safety and quality of these eye lubricants cannot be guaranteed.

What You Should Do

This recall affects AvKARE brand eye lubricants including Artificial Tears, Carboxymethylcellulose Sodium Ophthalmic Gel and Solution, and other moisturizing eye drops sold in 0.5 FL OZ (15 mL) dropper bottles.
Identify your product by checking the NDC code (such as 50268-043-15 or 50268-068-15) and the lot number printed on the bottle or outer carton. See the Affected Products section below for the full list of affected codes.
If you have health concerns after using these products, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact BRS Analytical Services, LLC directly for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3%

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

126 (Exp 10/26/25)

127 (Exp 10/30/25)

128 (Exp 11/02/25)

129 (Exp 11/06/25)

162 (Exp 5/09/26)

163 (Exp 5/14/26)

164 (Exp 5/20/26)

165 (Exp 5/23/26)

166 (Exp 5/29/26)

167 (Exp 6/03/26)

168 (Exp 6/06/26)

169 (Exp 6/10/26)

170 (Exp 6/13/26)

193 (Exp 10/07/26)

194 (Exp 10/10/26)

195 (Exp 10/14/26)

196 (Exp 10/17/26)

197 (Exp 10/21/26)

198 (Exp 10/24/26)

199 (Exp 10/30/26)

NDC:

50268-043-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Carboxymethylcellulose Sodium Ophthalmic Gel 1%

Variants: 0.5 FL OZ (15 mL) bottle

Lot Numbers:

114 (Exp 9/04/25)

115 (Exp 9/06/25)

116 (Exp 9/10/25)

207 (Exp 12/05/26)

NDC:

50268-066-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

103 (Exp 4/26/25)

104 (Exp 5/03/25)

108 (Exp 6/29/25)

109 (Exp 7/18/25)

110 (Exp 8/17/25)

111 (Exp 8/22/25)

112 (Exp 8/27/25)

113 (Exp 9/18/25)

125 (Exp 10/23/25)

130 (Exp 11/09/25)

131 (Exp 11/14/25)

132 (Exp 11/27/25)

133 (Exp 11/30/25)

134 (Exp 12/05/25)

135 (Exp 12/11/25)

136 (Exp 12/14/25)

137 (Exp 1/02/26)

139 (Exp 1/15/26)

140 (Exp 1/19/26)

141 (Exp 1/25/26)

151 (Exp 3/18/26)

152 (Exp 3/21/26)

153 (Exp 3/25/26)

154 (Exp 3/28/26)

155 (Exp 4/01/26)

156 (Exp 4/08/26)

157 (Exp 4/11/26)

160 (Exp 4/26/26)

180 (Exp 8/08/26)

181 (Exp 8/12/26)

182 (Exp 8/18/26)

183 (Exp 8/21/26)

184 (Exp 8/26/26)

185 (Exp 9/04/26)

186 (Exp 9/09/26)

187 (Exp 9/16/26)

188 (Exp 9/18/26)

189 (Exp 9/21/26)

190 (Exp 9/25/26)

191 (Exp 9/28/26)

192 (Exp 10/02/26)

208 (Exp 12/11/26)

209 (Exp 12/16/26)

212 (Exp 1/15/27)

213 (Exp 1/21/27)

214 (Exp 1/24/27)

215 (Exp 2/02/27)

216 (Exp 2/04/27)

224 (Exp 3/27/27)

NDC:

50268-068-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Lubricant Eye Drops Solution (Polyethylene Glycol 400 0.4%/Propylene Glycol 0.3%)

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

117 (Exp 9/20/25)

118 (Exp 9/25/25)

119 (Exp 9/27/25)

121 (Exp 10/05/25)

161 (Exp 5/01/26)

171 (Exp 6/18/26)

172 (Exp 6/24/26)

174 (Exp 7/01/26)

175 (Exp 7/08/26)

200 (Exp 11/05/26)

201 (Exp 11/10/26)

202 (Exp 11/13/26)

203 (Exp 11/18/26)

204 (Exp 11/21/26)

205 (Exp 11/25/26)

206 (Exp 12/02/26)

219 (Exp 2/24/27)

221 (Exp 3/02/27)

222 (Exp 3/05/27)

NDC:

50268-126-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Polyvinyl Alcohol Ophthalmic Solution 1.4%

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

120 (Exp 10/02/25)

122 (Exp 10/09/25)

123 (Exp 10/12/25)

124 (Exp 10/16/25)

138 (Exp 1/08/26)

142 (Exp 1/29/26)

143 (Exp 2/01/26)

144 (Exp 2/07/26)

145 (Exp 2/12/26)

146 (Exp 2/15/26)

147 (Exp 2/21/26)

148 (Exp 2/27/26)

149 (Exp 3/04/26)

150 (Exp 3/11/26)

158 (Exp 4/15/26)

159 (Exp 4/22/26)

176 (Exp 7/24/26)

177 (Exp 7/28/26)

178 (Exp 7/31/26)

179 (Exp 8/05/26)

NDC:

50268-678-15

Distributed by: AvKARE, Pulaski, TN 38478

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96741

Status: Active

Manufacturer: BRS Analytical Services, LLC

Sold By: AvKARE; pharmaceutical distributors; retail pharmacies

Manufactured In: United States

Units Affected: 5 products (13,872 cases (24 cartons per case); 1,610 cases (24 cartons per case); 32,876 cases (24 cartons per case); 13,104 cases (24 cartons per case); 14,333 cases (24 cartons per case))

Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES · Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.

Summary

Risk

What You Should Do

This recall affects AvKARE brand eye lubricants including Artificial Tears, Carboxymethylcellulose Sodium Ophthalmic Gel and Solution, and other moisturizing eye drops sold in 0.5 FL OZ (15 mL) dropper bottles.

Identify your product by checking the NDC code (such as 50268-043-15 or 50268-068-15) and the lot number printed on the bottle or outer carton. See the Affected Products section below for the full list of affected codes.

If you have health concerns after using these products, contact your healthcare provider or pharmacist immediately. Return any unused product to the place of purchase for a refund, throw it away, or contact BRS Analytical Services, LLC directly for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information regarding this recall.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Artificial Tears Ophthalmic Solution, Dextran 70.01%/Glycerin 0.2%/Hypromellose 0.3%

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

126 (Exp 10/26/25)

127 (Exp 10/30/25)

128 (Exp 11/02/25)

129 (Exp 11/06/25)

162 (Exp 5/09/26)

163 (Exp 5/14/26)

164 (Exp 5/20/26)

165 (Exp 5/23/26)

166 (Exp 5/29/26)

167 (Exp 6/03/26)

168 (Exp 6/06/26)

169 (Exp 6/10/26)

170 (Exp 6/13/26)

193 (Exp 10/07/26)

194 (Exp 10/10/26)

195 (Exp 10/14/26)

196 (Exp 10/17/26)

197 (Exp 10/21/26)

198 (Exp 10/24/26)

199 (Exp 10/30/26)

NDC:

50268-043-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Carboxymethylcellulose Sodium Ophthalmic Gel 1%

Variants: 0.5 FL OZ (15 mL) bottle

Lot Numbers:

114 (Exp 9/04/25)

115 (Exp 9/06/25)

116 (Exp 9/10/25)

207 (Exp 12/05/26)

NDC:

50268-066-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

103 (Exp 4/26/25)

104 (Exp 5/03/25)

108 (Exp 6/29/25)

109 (Exp 7/18/25)

110 (Exp 8/17/25)

111 (Exp 8/22/25)

112 (Exp 8/27/25)

113 (Exp 9/18/25)

125 (Exp 10/23/25)

130 (Exp 11/09/25)

131 (Exp 11/14/25)

132 (Exp 11/27/25)

133 (Exp 11/30/25)

134 (Exp 12/05/25)

135 (Exp 12/11/25)

136 (Exp 12/14/25)

137 (Exp 1/02/26)

139 (Exp 1/15/26)

140 (Exp 1/19/26)

141 (Exp 1/25/26)

151 (Exp 3/18/26)

152 (Exp 3/21/26)

153 (Exp 3/25/26)

154 (Exp 3/28/26)

155 (Exp 4/01/26)

156 (Exp 4/08/26)

157 (Exp 4/11/26)

160 (Exp 4/26/26)

180 (Exp 8/08/26)

181 (Exp 8/12/26)

182 (Exp 8/18/26)

183 (Exp 8/21/26)

184 (Exp 8/26/26)

185 (Exp 9/04/26)

186 (Exp 9/09/26)

187 (Exp 9/16/26)

188 (Exp 9/18/26)

189 (Exp 9/21/26)

190 (Exp 9/25/26)

191 (Exp 9/28/26)

192 (Exp 10/02/26)

208 (Exp 12/11/26)

209 (Exp 12/16/26)

212 (Exp 1/15/27)

213 (Exp 1/21/27)

214 (Exp 1/24/27)

215 (Exp 2/02/27)

216 (Exp 2/04/27)

224 (Exp 3/27/27)

NDC:

50268-068-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Lubricant Eye Drops Solution (Polyethylene Glycol 400 0.4%/Propylene Glycol 0.3%)

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

117 (Exp 9/20/25)

118 (Exp 9/25/25)

119 (Exp 9/27/25)

121 (Exp 10/05/25)

161 (Exp 5/01/26)

171 (Exp 6/18/26)

172 (Exp 6/24/26)

174 (Exp 7/01/26)

175 (Exp 7/08/26)

200 (Exp 11/05/26)

201 (Exp 11/10/26)

202 (Exp 11/13/26)

203 (Exp 11/18/26)

204 (Exp 11/21/26)

205 (Exp 11/25/26)

206 (Exp 12/02/26)

219 (Exp 2/24/27)

221 (Exp 3/02/27)

222 (Exp 3/05/27)

NDC:

50268-126-15

Distributed by: AvKARE, Pulaski, TN 38478

Product: Polyvinyl Alcohol Ophthalmic Solution 1.4%

Variants: 0.5 FL OZ (15 mL) dropper bottle

Lot Numbers:

120 (Exp 10/02/25)

122 (Exp 10/09/25)

123 (Exp 10/12/25)

124 (Exp 10/16/25)

138 (Exp 1/08/26)

142 (Exp 1/29/26)

143 (Exp 2/01/26)

144 (Exp 2/07/26)

145 (Exp 2/12/26)

146 (Exp 2/15/26)

147 (Exp 2/21/26)

148 (Exp 2/27/26)

149 (Exp 3/04/26)

150 (Exp 3/11/26)

158 (Exp 4/15/26)

159 (Exp 4/22/26)

176 (Exp 7/24/26)

177 (Exp 7/28/26)

178 (Exp 7/31/26)

179 (Exp 8/05/26)

NDC:

50268-678-15

Distributed by: AvKARE, Pulaski, TN 38478

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 96741

Status: Active

Manufacturer: BRS Analytical Services, LLC

Sold By: AvKARE; pharmaceutical distributors; retail pharmacies

Manufactured In: United States

Distributed To: Nationwide