The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1314-2022·Announced 2022-08-17

FDA Recalls SYSTANE Lubricant Eye Drops Due to Improper Storage

McKesson Medical-Surgical Inc. is recalling 47 bottles of SYSTANE Lubricant Eye Drops nationwide. The products were stored outside label specifications, violating manufacturing practices.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: This is an FDA Class II recall with no reported illnesses or injuries. The hazard—improper storage—is theoretical, with no evidence of actual harm reported in the source, making this a precautionary quality-based recall.

Plain-English summary

SYSTANE Lubricant Eye Drops (Polyethylene Glycol 400 0.4% and Propylene Glycol 0.3%) in 15 mL and 30 mL bottles are being recalled by McKesson Medical-Surgical Inc. The affected NDC codes are 0065-0429-15 and 0065-0429-30.

The FDA issued this recall because the products were stored outside the manufacturer's labeled storage specifications, which constitutes a Current Good Manufacturing Practices (CGMP) deviation. Products not stored according to label requirements may not maintain their intended quality, efficacy, or safety.

The affected 47 bottles were distributed nationwide in the United States. If you have purchased these eye drops, discontinue use and contact your pharmacy or McKesson Medical-Surgical Inc. for a replacement or refund.

The recalled product

Product
SYSTANE LUBRICANT (POLYETHYLENE GLYCOL 400 AND PROPYLENE GLYCOL)
Brand
SYSTANE LUBRICANT
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Ophthalmic / Eye Care
Hazard
Affected units
47

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 (2)

  • Part# a) 0065042915
  • b) 0065042930

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 17 recalled by Mckesson Medical-Surgical Inc. Corporate Office 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 17 products in this recall →

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