The Recall Desk
Agency classClass IIOur severity:ModerateFDA (Drugs)·D-1316-2022·Announced 2022-08-17

Eye Drops Recalled for Improper Storage Outside Specifications

SYSTANE BALANCE lubricant eye drops (12 boxes, nationwide) are being recalled because they were stored outside the manufacturer's label specifications. The FDA classified this as a Class II recall.

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: FDA Class II recall with no reported illnesses or injuries. The hazard is improper storage outside manufacturer specifications—a precautionary CGMP deviation without documented product contamination or adverse events.

Plain-English summary

SYSTANE BALANCE Lubricant Eye Drops (0.6% propylene glycol, 10 mL bottles) are being recalled. The affected product consists of 12 boxes distributed nationwide in the United States. NDC 0065-1433-02, manufactured by Alcon Laboratories, Inc.

The recall was initiated because the products were stored outside the drug label specifications. This storage deviation violates Current Good Manufacturing Practices (CGMP) requirements.

Consumers who have purchased this product should discontinue use and consult their eye care provider if they have concerns about their use. Contact McKesson Medical-Surgical Inc. or Alcon Laboratories with product questions.

The recalled product

Product
SYSTANE BALANCE (PROPYLENE GLYCOL)
Brand
SYSTANE BALANCE
Manufacturer
Mckesson Medical-Surgical Inc. Corporate Office
Category
Drug — Ophthalmic / Eye Drops
Hazard
Affected units
12

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)

  • Part# 0065143302

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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