Public Notice - Recall of Nutrifill Lots HFH, HGC, HGI, HGN, HKF, and HKK because products may not be sterile

On May 15, 2025, Contamac Solutions, Inc. announced a voluntary product recall in the United States for lots HFH, HGC, HGI, HGN, HKF, HKK of Nutrifill, a preservative-free contact lens insertion solution. These lots were distributed in the United States between 06/16/2024 and 10/18/2024. Contamac Solutions, Inc. elected to voluntarily conduct this recall following the investigation of customer complaints describing red, irritated, burning, and painful eyes when using Nutrifill with their scleral lenses, some with the development of infections and corneal ulcers. Upon retesting these lots for sterility, lots HFH, HGI, HGN, and HKK failed to return sterile results on at least one occasion. From seven complaints, we have received reports of twenty-three serious injuries that the recalled product may have contributed to. This product recall does not affect other batches or lots of Nutrifill. Contamac Solutions, Inc. is working closely with the United States Food and Drug Administration on this voluntary recall.

Due to quality failures that occurred with our contract manufacturer during the production of the product, we cannot confirm the sterility of the 605,465 ampoules manufactured within the lots HFH, HGC, HGI, HGN, HKF, and HKK. A non-sterile solution with potential bacterial contamination can cause infections that may lead to vision loss if untreated. Individuals that have recently undergone eye surgery, have an active external ocular disease, or have a condition affecting the integrity of the eye are at higher risk of complications from using a non-sterile product.

Contamac Solutions, Inc. is dedicated to product safety and has collaborated with its contract manufacturer to enhance processes and implement corrective and preventative measures. 

Consumers who may have these affected products in their possession should follow the steps outlined below:

1. Refer to the package label to verify the product is impacted (i.e. lot HFH). 

The lot number can be found on a sticker affixed to the side of the carton below the contact information (example above) or embossed on the front of the ampoule below the Nutrifill logo (example above).

2. If your product is impacted, immediately quarantine and stop using the product.

3. After completing all instructions, please destroy and discard all vials of Nutrifillfrom lots HFH, HGC, HGI, HGN, HKF, HKK (i.e. remove vial cap and empty contents before discarding). Alternatively, the remaining product can be returned to the point of purchase for a refund. Those who purchased from Contamac Solutions directly can request a return by emailing recall@contamacsolutions.com

4. Complete the Customer Response Form

5.  Provide the recall notification to all those who need to be aware, including others within your organization or to any organization where the affected devices may have been transferred.

Eye care professionals, distributors and wholesalers who may have purchased product from Nutrifill lots HFH, HGC, HGI, HGN, HKF, HKK are asked to immediately quarantine and discontinue sale of the impacted product. Complete the Distributor Response Form and return all remaining stock of Nutrifill from lots HFH, HGC, HGI, HGN, HKF, HKK for a refund. Request a return by emailing recall@contamacsolutions.com

 

For further information on the recall or assistance with the completion of the online report form, please contact:

Toll Free: 1-303-500-0561

Email: recall@contamacsolutions.com