The Recall Desk
SevereFDA (Drugs)·D-0309-2024·Announced 2024-02-14

Lubricant Eye Drops Recalled Due to Non-Sterility Concerns

Rite Aid is recalling 7,296 bottles of lubricant eye drops nationwide due to non-sterility. The FDA has classified this as a Class I recall.

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 requires a minimum severity score of 4. Non-sterility in eye drops poses direct contamination and infection risk.

Plain-English summary

Lubricant eye drops distributed by Rite Aid are being recalled due to non-sterility. The product, containing propylene glycol 0.6% and packaged in 0.33 FL OZ (10 mL) twin packs, was manufactured by Kilitch Healthcare India Limited with NDC 11822-4811-3. The FDA has classified this as a Class I recall, the most serious category.

All lots of the affected product—7,296 bottles—are included in this voluntary recall, which was initiated on November 13, 2023. The product was distributed nationwide within the United States.

Consumers who have purchased these eye drops should not use the product.

The recalled product

Product
Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, PA 17011, NDC 11822-4811-3 Retail Labeler: Rite Aid
Manufacturer
Kilitch Healthcare India Limited
Hazard
  • non-sterility

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.