CLASS II ONGOING Drug recall · Reported 13 Nov 2024 · FDA Enforcement Report
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDC
FDC is recalling Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, distributed in New Jersey. The recall was initiated on 29 Oct 2024 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0035-2025
- FDA event ID
- 95648
- Recalling firm
- FDC, Aurangabad, Maharashtra State, N/A
- Brand
- Timolol Maleate
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 29 Oct 2024
- FDA classified
- 1 Nov 2024
- Reported
- 13 Nov 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 29 Oct 2024 | Recall initiated by company | |
| 1 Nov 2024 | Classified by FDA | +3 days |
| 13 Nov 2024 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-05.
Where it was distributed
Distributed to one Us Distributor in NJ.
Questions about this recall
Why was it recalled?
Defective Container: Unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle
Which lots are affected?
Lot #: 083L051, Exp. Date: 11/2025
Where was it sold?
Distributed to one Us Distributor in NJ.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from FDC
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Sterility | Nationwide |
Other Timolol recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate | FDC | Packaging Defects | Nationwide |