The Recall Desk
SevereFDA (Drugs)·D-0296-2024·Announced 2024-02-14

CVS Multi Action Relief Drops Recalled for Non-Sterility

CVS brand Multi Action Relief Drops are being recalled nationwide due to non-sterility, which could allow microbial contamination in the product. The voluntary recall covers all lots of the eye drops.

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: This is an FDA Class I drug recall, which requires a minimum severity score of 4. Although no illnesses are reported in the recall notice, the non-sterility of eye drops presents a serious risk of microbial contamination directly to the eyes.

Plain-English summary

CVS brand Multi Action Relief Drops (containing polyvinyl alcohol 0.5%, povidone 0.6%, and tetrahydrozoline 0.05%) are the subject of a voluntary recall affecting all lots nationwide. The recall covers 253,080 bottles of the 0.5 FL OZ (15 mL) product distributed by CVS Pharmacy Inc.

The recall was initiated due to a sterility failure, meaning the product may not be sterile. This creates a risk of microbial contamination in the eye drops, which are applied directly to the eyes.

The recall was voluntary and initiated by the manufacturer, Kilitch Healthcare India Limited, on November 13, 2023.

Consumers who have purchased this product should stop using it and consult their pharmacist or healthcare provider for guidance on alternative eye care products.

The recalled product

Product
CVS brand Multi Action Relief Drops (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline 0.05%) packaged in 0.5 FL OZ (15mL) bottles, Distributed by CVS Pharmacy Inc. One CVS Drive Woonsocket, RI 02895. NDC 76168-706-15
Manufacturer
Kilitch Healthcare India Limited
Hazard
  • non-sterility
  • microbial-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.