Tobramycin Opthalmic Solution USP — Class III drug recall D-1086-2023
Ongoing recall by ALEMBIC PHARMACEUTICALS, INC., reported 2023-08-23, distributed nationwide. Failed Impurities/Degradation Specifications
| Recall number | D-1086-2023 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | ALEMBIC PHARMACEUTICALS, INC., Bedminster, NJ, United States |
| Recall initiated | 2023-07-27 |
| Classified | 2023-08-17 |
| Reported by FDA | 2023-08-23 |
| Distributed | Nationwide (US) |
| Quantity | 82,400 bottles |
| Reason classes | specification failure |
| NDC | 62332-0518, 62332-0518-05 |
| Lot numbers | AMR103, AMR201 |
| Expiration dates | 2023-10, 2024-06 |
Product
Tobramycin Opthalmic Solution USP, 0.3%, 5mL bottle, Rx only, Manufactured for: Alembic Pharmaceuticals, Bedminster, NJ 07921, USA, NDC 62332-518-05
Reason for recall
Failed Impurities/Degradation Specifications
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-1086-2023. 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.