Betimol — Class II drug recall D-0374-2024
Terminated recall by Thea Pharma, Inc., reported 2024-03-20, distributed nationwide. Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
| Recall number | D-0374-2024 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Thea Pharma, Inc., Waltham, MA, United States |
| Recall initiated | 2024-03-05 |
| Classified | 2024-03-11 |
| Reported by FDA | 2024-03-20 |
| Terminated | 2025-06-30 |
| Distributed | Nationwide (US) |
| Quantity | 5,476 bottles |
| Reason classes | sterility, specification failure |
| NDC | 82584-0001, 82584-0001-05, 82584-0002, 82584-0002-05, 82584-0002-15 |
| Lot numbers | 435019 |
| Expiration dates | 2024-11 |
Product
Betimol (timolol ophthalmic solution) 0.5%, 15mL bottles, Rx only, Manufactured for: Thea Pharma Inc. Lexington, MA 02420, NDC 82584-002-15
Reason for recall
Lack of Assurance of Sterility: Out of specification for volume and compromised container closure.
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0374-2024. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.