Thea Pharma, Inc. FDA Recalls

3 recalls on file across drugs, 0 of them Class I and 2 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: TheaClass IIApr 23, 2026Lack of Assurance of Sterility: This recall has been initiat	Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during	Class IIDrugs	Apr 23, 2026
iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%), 0.33 Fl oz (10 mL), Made in France, Distributed by: Thea Pharma IncClass IIApr 23, 2026Lack of Assurance of Sterility: This recall has been initiat	Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during	Class IIDrugs	Apr 23, 2026
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 024Class IIMar 5, 2024Lack of Assurance of Sterility: Out of specification for vol	Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.	Class IIDrugs	Mar 5, 2024