The Recall Desk
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.

What this means for you

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
  • improper-storage
  • cgmp-deviation

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.

Related recalls

Same category