FDA-Drug2026-09-30Class IIPROCESSING DEFECT

Reliable-1 Laboratories Lubricating Tears recalled for lack of sterility assurance

OTHERNationwide distributionDrugs

What this means

Reliable-1 Laboratories Lubricating Tears eye drops may not be sterile due to manufacturing or quality control issues. The FDA is recalling specific lots distributed nationwide to ensure patient safety.

  • Check if you own Reliable-1 Lubricating Tears (0.5 FL OZ bottles) with lot numbers 3171, 3174, 3275, or 3304.
  • Do not use the product if you have one of the affected lots.
  • Contact your pharmacy or healthcare provider for a replacement or alternative eye drops.
  • Visit www.reliable1labs.com or contact the distributor for more information.
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The agency's original wording
Hazard

Lack of Assurance of Sterility

Intended for
All ages
Illnesses reported
None reported
Sold states
USA Nationwide
Affected count
47616 bottles
Manufactured in
109 S 2nd St, Dupo, IL, United States
Products
Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.

Official notice

https://www.accessdata.fda.gov/scripts/ires/index.cfm?Product=D-0859-2026

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