CLASS II ONGOING Drug recall · Reported 14 May 2025 · 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 nationwide in the US. The recall was initiated on 18 Apr 2025 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-0403-2025
- FDA event ID
- 96740
- Recalling firm
- FDC, Aurangabad, Maharashtra State, N/A
- Brand
- Timolol Maleate
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 18 Apr 2025
- FDA classified
- 5 May 2025
- Reported
- 14 May 2025
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Eye Drops
Timeline
| 18 Apr 2025 | Recall initiated by company | |
| 5 May 2025 | Classified by FDA | +17 days |
| 14 May 2025 | Published in enforcement report | +9 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.
Product as listed by the FDA
Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-514-01.
Where it was distributed
U.S. Nationwide
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 #: 083I098, Exp. Date 08/31/2025
Where was it sold?
U.S. Nationwide
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 26 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 | Other | 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 | Other | NJ |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
Other Timolol recalls
All 20| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate | FDC | Other | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate | FDC | Packaging Defects | Nationwide |