Betaxolol Ophthalmic Solution — Class II drug recall D-0004-2022
Terminated recall by Akorn, Inc., reported 2021-10-13, distributed nationwide. Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing a
| Recall number | D-0004-2022 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Akorn, Inc., Lake Forest, IL, United States |
| Recall initiated | 2021-10-04 |
| Classified | 2021-10-07 |
| Reported by FDA | 2021-10-13 |
| Terminated | 2022-08-17 |
| Distributed | Nationwide (US) |
| Quantity | 10,210 bottles |
| Reason classes | microbial contamination, sterility, specification failure |
| NDC | 17478-0705-10, 17478-0705-11 |
| Lot numbers | 0B61A |
| Expiration dates | 2022-01-31 |
Product
Betaxolol Ophthalmic Solution, USP, 0.5%, (Betaxolol HCl 5.6 mg/mL), 5 mL dropper bottle, Rx only, Sterile, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Carton NDC: 17478-705-10, Bottle NDC 17478-705-11
Reason for recall
Microbial Contamination of Sterile Products: Confirmed sterility failure identified during stability testing at the 12-month time point.
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-0004-2022. 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.