The Recall Desk
SevereFDA (Drugs)·D-0311-2024·Announced 2024-02-14

Up&Up Dry Eye Relief Nationwide Recall for Non-Sterility

Up&Up brand dry eye relief (0.5 FL OZ) distributed by Target nationwide is being recalled due to non-sterility. The FDA Class I recall affects all lots of this ophthalmic drug.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: FDA Class I classification mandates a minimum severity score of 4 per the severity rubric. Non-sterility in an ophthalmic pharmaceutical product poses serious health risk due to potential for microbial contamination and infection.

Plain-English summary

Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) Twin Pack bottles is being recalled. The product was distributed by Target Corporation nationwide across the United States. The recall affects all lots, totaling 137,544 bottles.

The manufacturer, Kilitch Healthcare India Limited, initiated this voluntary recall on November 13, 2023, because the product did not meet sterility standards. The FDA classified the recall as Class I on February 5, 2024, indicating that the non-sterility poses a serious potential health hazard.

The recall status is ongoing as of the latest FDA update.

The recalled product

Product
Up&Up brand dry eye relief (Carboxymethylcellulose 0.5%) packaged in 0.5 FL OZ (15 mL) each bottles (Twin Pack), Distributed by: Target Corporation Minneapolis, MN 55403, NDC 76168-800-30
Manufacturer
Kilitch Healthcare India Limited
Hazard
  • non-sterility
  • infection-risk

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (1)

  • All lots

Distribution

Distributed nationwide across the United States.