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Serious recall: Injury is possible or has been reported. Take action promptly.

USV Private Limited 2025-10-29 Health serious FDA
Health · FDA · Recall #FDA-D-0034-2026

Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles,… Recall

Issued October 29, 2025 · USV Private Limited

In October 2025, USV Private Limited recalled the Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles,…, a serious health recall reported by the FDA.

Compiled by Maya Ellison, RecallCheckr

What this means for you

Failed Impurities/Degradation Specifications: The result for 'Any individual unspecified impurity' exceeds the specification limit.

What you should do

  1. 1 Stop using Olopatadine Hydrochloride Ophthalmic Solution USP 0.1 %, 5 mL (0.17 FL OZ) bottles,… right away.
  2. 2 Set it aside where it won't be used by mistake.
  3. 3 Contact USV Private Limited to arrange your voluntary. See the official notice below for contact details.
  4. 4 Keep the product until your remedy is fully processed. You may need it.
Official remedy (Voluntary):

Recall details

Brand
USV Private Limited
Category
Health
Recall date
October 29, 2025
Units affected
Not reported
Sold at
Nationwide within the United States
Recall number
FDA-D-0034-2026
Made in
India
Issuing agency
FDA

In context

  • USV Private Limited has 1 recall in our database.
  • We're tracking 3,576 Health recalls in our database.
  • This is the 691st Health recall we've logged in 2025.
Read the official FDA notice

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