CLASS II Drug recall · Reported 20 Mar 2024 · FDA Enforcement Report
Betimol (timolol ophthalmic solution) recalled by Thea Pharma
Thea Pharma is recalling Betimol (timolol ophthalmic solution) 0.5%, distributed nationwide in the US. The recall was initiated on 5 Mar 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0374-2024
- FDA event ID
- 94146
- Recalling firm
- Thea Pharma, Waltham, MA
- Brand
- Betimol
- Manufacturer
- Thea Pharma Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2024
- FDA classified
- 11 Mar 2024
- Reported
- 20 Mar 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 5 Mar 2024 | Recall initiated by company | |
| 11 Mar 2024 | Classified by FDA | +6 days |
| 20 Mar 2024 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Where it was distributed
Product was distributed nationwide within the United States
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Which lots are affected?
Lot #: 435019, Exp. Date 11/2024
Where was it sold?
Product was distributed nationwide within the United States
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Thea Pharma
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) recalledIvizia Dry Eye | Thea Pharma | Sterility | Nationwide |
| Drug | CLASS II | Similasan, iVIZIA, Sterile Lubricant Eye Drops (Povidone 0.5%) recalled | Thea Pharma | Sterility | Nationwide |
Other Timolol recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |