Betimol (timolol ophthalmic solution) 0.5% recall
FDA recall D-0374-2024 · initiated Mar 5, 2024
Thea Pharma, Inc. recalled Betimol (timolol ophthalmic solution) 0.5% in Mar 2024 — an FDA Class II recall (D-0374-2024) because Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
May cause temporary or medically reversible harm; low probability of serious harm.
Why it was recalled
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Sterility could not be assured
The maker could not guarantee the product was sterile. That matters most for injections and eye products, where a contaminated dose reaches past the body's defences.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 5,476 bottles
Details
- Product
- Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
- Recalling company
- Thea Pharma
- Classification
- Class II
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Product was distributed nationwide within the United States
- Initiated
- Mar 5, 2024
- FDA report date
- Mar 20, 2024
This recall is linked to a product we cover: Betimol →
Frequently asked
- Was Betimol (timolol ophthalmic solution) 0.5% recalled?
- Thea Pharma, Inc. recalled Betimol (timolol ophthalmic solution) 0.5% in Mar 2024 — an FDA Class II recall (D-0374-2024) because Lack of Assurance of Sterility: Out of specification for volume and compromised container closure. May cause temporary or medically reversible harm; low probability of serious harm.
- Why was Betimol (timolol ophthalmic solution) 0.5% recalled?
- Per the FDA enforcement record, the reason for recall D-0374-2024 was: Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
- Is a recalled Betimol (timolol ophthalmic solution) 0.5% dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. May cause temporary or medically reversible harm; low probability of serious harm. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Betimol (timolol ophthalmic solution) 0.5% are affected?
- Distributed: Product was distributed nationwide within the United States. The recall covers these lots — Lot #: 435019, Exp. Date 11/2024. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0374-2024.