The Recall Desk
SevereFDA (Drugs)·D-0290-2024·Announced 2024-02-14

CVS Health Lubricant Eye Drops Recalled Due to Non-Sterility

CVS Health brand Lubricant Eye Drops are being recalled due to non-sterility concerns. Kilitch Healthcare India Limited initiated this voluntary recall affecting 386,256 bottles distributed nationwide.

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 evaluation rubric. The non-sterility issue with eye drops poses a potential health hazard, though no reported illnesses or injuries are mentioned in the source material.

Plain-English summary

CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%) are being recalled. The product is available in 0.5 FL OZ (15mL) single packs (NDC 76168-702-15) and 0.5 FL OZ (15mL) twin packs (NDC 76168-702-30). 386,256 bottles are affected across all lot numbers.

Kilitch Healthcare India Limited, the manufacturer, initiated this voluntary recall due to non-sterility concerns. The product was distributed nationwide within the United States by CVS Pharmacy Inc.

Consumers who have purchased this product should stop using it and dispose of it or return it to the place of purchase. The FDA classified this recall as Class I, indicating a serious health hazard. Consumers with questions should contact CVS Pharmacy or their healthcare provider.

The recalled product

Product
CVS Health brand Lubricant Eye Drops (Carboxymethylcellulose Sodium 0.5%), packaged in a) 0.5 FL OZ (15mL) bottles (Single Pack) (NDC 76168-702-15) and b) 0.5 FL OZ (15 mL) bottles (Twin pack) (NDC 76168-702-30), Distributed by: CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 028
Manufacturer
Kilitch Healthcare India Limited
Hazard
  • non-sterility
  • contamination

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.