CLASS II ONGOING Drug recall · Reported 28 Aug 2024 · FDA Enforcement Report
Timolol Maleate Ophthalmic Solution recalled by FDC
FDC is recalling Timolol Maleate Ophthalmic Solution USP, 5%, distributed nationwide in the US. The recall was initiated on 12 Aug 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-0642-2024
- FDA event ID
- 95140
- Recalling firm
- FDC, Aurangabad, Maharashtra State
- Brand
- Timolol Maleate
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 12 Aug 2024
- FDA classified
- 22 Aug 2024
- Reported
- 28 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Eye Drops
Timeline
| 12 Aug 2024 | Recall initiated by company | |
| 22 Aug 2024 | Classified by FDA | +10 days |
| 28 Aug 2024 | Published in enforcement report | +6 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: patients are unable to get the solution out of the bottle as the spike of the cap was lodged in the nozzle of the product bottle.
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (NDC 64980-514-05), and b) 10mL bottle (NDC 64980-514-01), Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey
Where it was distributed
Nationwide U.S.A.
Questions about this recall
Is Timolol Maleate Ophthalmic Solution USP, 5% recalled?
Yes. FDC recalled Timolol Maleate Ophthalmic Solution USP, 5% on 12 Aug 2024. The recall is Class II and its status is Ongoing. Recall number D-0642-2024.
Why was it recalled?
Defective Container: patients are 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 #: a) 083K063, Exp 10/31/2025; b) 083I091, Exp 08/31/2025.
Where was it sold?
Nationwide U.S.A.
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, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 3% as base, package recalledCiprofloxacin | FDC | Packaging Defects | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
| Drug | CLASS II | Ciprofloxacin Ophthalmic Solution USP, 3% as base, Sterile, package recalledCiprofloxacin | FDC | Sterility | Nationwide |
Other Timolol recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | Nationwide |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 25%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |
| Drug | CLASS II | Timolol Maleate Ophthalmic Solution USP, 5%, Sterile recalled by FDCTimolol Maleate | FDC | Sterility | NJ |