The Recall Desk
Agency classClass IOur severity:SevereFDA (Drugs)·D-0919-2023·Announced 2023-07-19

EzriCare Artificial Tears Eye Drops Recalled for Bacterial Contamination

EzriCare Artificial Tears eye drops are being recalled nationwide due to bacterial contamination found in unopened bottles. The FDA identified non-sterile products that could pose a risk to eye health.

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 score of 4. The recall involves confirmed bacterial contamination in unopened eye-drop products, which pose a direct risk to sensitive eye tissue, though no illnesses have been reported.

Plain-English summary

EzriCare Artificial Tears Lubricant Eye Drops (10 MG in 1 ml, 15 ml bottles) are being recalled because FDA testing found bacterial contamination in unopened products. The affected product was distributed nationwide in the United States.

The recalled product includes multiple lot numbers: PCMI005 (expiring August 2024) and lot numbers PCMJ001, PCMJ002, PCMJ004, PCMJ005, PCMJ006, PCMJ008, PCMJ009, PCMJ010, PCMJ011, PCMJ012, PCMJ013, PCMJ014, and PCMJ015 (expiring March 2025). A total of 400,008 bottles were distributed through two distributors who further distributed the product nationwide.

Consumers who have purchased these eye drops should stop using them immediately and discard them safely. While no illnesses have been reported to date, applying contaminated eye drops could introduce bacteria to the eye and potentially cause infection or other adverse effects. Consult a healthcare provider if you have used this product and experience any eye problems.

The recalled product

Product
Artificial Tears (Carboxymethylcellulose Sodium) Lubricant Eye Drops, 10 MG in 1 ml, 1/2 fl oz (15 ml) bottle, Distributed by. EzriCare, LLC, Lakewood, NJ, NDC 79503-0101-15.
Manufacturer
Global Pharma Healthcare Private Limited
Category
Drug — Lubricant Eye Drops
Hazard
Affected units
400,008

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 (16)

  • Lot #: PCMI005
  • Exp. date AUG-2024
  • PCMJ001
  • PCMJ002
  • PCMJ004
  • PCMJ005
  • PCMJ006
  • PCMJ008
  • PCMJ009
  • PCMJ010
  • PCMJ011
  • PCMJ012
  • PCMJ013
  • PCMJ014
  • PCMJ015
  • Exp. date MAR-2025

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Global Pharma Healthcare Private 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 4 products in this recall →

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