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.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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
- Category
- Drug — Ophthalmic
- Hazard
- Affected units
- 7,296
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.
Part of a larger recall action
This product is one of 22 recalled by Kilitch Healthcare India Limited under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 22 products in this recall →Related recalls
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