FreshRecalls

⚠ Data freshness notice: the most recent refresh of NHTSA was incomplete, so a very recent recall may be missing. Everything shown is accurate as of the last checked time on this page — for anything time-critical, confirm with the official sources linked below.

FDAClass II · Drug · Recalled May 6, 2026

Similasan recall — Thea Pharma, Inc.

Hazard: Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.

Class II: may cause temporary or medically reversible health consequences.

View the official FDA enforcement record (openFDA) ↗

Official recall ID
D-0501-2026
Brand
Thea Pharma
Classification
Class II
Recall status
Ongoing
Initiated
Voluntary: Firm initiated

Description

Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma Inc., Waltham, MA 02451, NDC 59262-700-11

Affected products

Companies & origin

Recalling firm location
Waltham, MA, United States
Firm address
303 Wyman St, 02451-1208

Identifying details (verbatim from the notice)

Product codes / lots
Lot# 5S30B, 5S30C, Exp Date: April 30, 2026; Lot# 5S31B, 6S57B, Exp Date: May 31, 2026.
Distribution
Nationwide within the United States
Firm notified the public via
Letter
FDA event ID
98792
Recall initiated
April 23, 2026
FDA classified
April 28, 2026
FDA report date
May 6, 2026

Source: U.S. Food & Drug Administration. This page mirrors the official public-domain record verbatim; the linked government source is authoritative. Source last checked July 23, 2026 at 11:04 PM UTC.

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