Timolol Maleate Sterile Opthalmic Solution — Class III drug recall D-1368-2020
Terminated recall by Rising Pharmaceuticals, Inc., reported 2020-07-01, distributed nationwide. Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer ca
| Recall number | D-1368-2020 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Rising Pharmaceuticals, Inc., Saddle Brook, NJ, United States |
| Recall initiated | 2019-11-15 |
| Classified | 2020-06-29 |
| Reported by FDA | 2020-07-01 |
| Terminated | 2022-08-22 |
| Distributed | Nationwide (US) |
| Quantity | 15,072 bottles |
| Reason classes | labeling, sterility |
| NDC | 64980-0513, 64980-0513-01, 64980-0513-05, 64980-0513-15, 64980-0514, 64980-0514-01, 64980-0514-05, 64980-0514-15 |
| Lot numbers | 089A016 |
| Expiration dates | 2020-12 |
Product
Timolol Maleate Sterile Opthalmic Solution,USP 0.25%, 5 mL, Rx Only, For Topical Application, Distributed by: Rising Pharmaceuticals, Inc. Saddle Brook, NJ 07863, Manufactured by: FDC Limited B-8, MDC Industrial Area, Waluj, Aurangabad - 431-136 Maharashtra, India, NDC 64980-513-05
Reason for recall
Labeling: Label mix-up: A case of Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml, had the outer carton for Timolol Maleate Sterile Ophthalmic solution USP 0.5%, 5ml but the bottle inside was Timolol Maleate Sterile Ophthalmic solution USP 0.25%, 5ml.
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-1368-2020. 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.