Waltham, MA, United States
Thea Pharma, Inc. recalls
2 recalls recorded since 2018, most recently on 23 April 2026. 1 is listed as ongoing. Status and classification are as published by the FDA.
Recalls2
Ongoing (FDA)1
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 23 April 2026
- Reason
- Lack of Assurance of Sterility: This recall has been initiated due to CGMP deviations found by the FDA during an inspection of the manufacturer.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0501-2026, D-0500-2026
- 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
- 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 82584-700-11
Terminated Class II Drugs
- Recall started
- 5 March 2024
- Terminated
- 30 June 2025
- Reason
- Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0374-2024
- Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.