CLASS II Drug recall · Reported 15 May 2024 · FDA Enforcement Report
Timolol Maleate Ophthalmic Solution recalled by FDC
FDC is recalling Timolol Maleate Ophthalmic Solution, USP, 5%, distributed in New Jersey. The recall was initiated on 25 Apr 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-0488-2024
- FDA event ID
- 94466
- Recalling firm
- FDC, Aurangabad, Maharashtra State, N/A
- Brand
- Timolol Maleate
- Manufacturer
- Rising Pharma Holdings, Inc.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 25 Apr 2024
- FDA classified
- 7 May 2024
- Reported
- 15 May 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Eye Drops
Timeline
| 25 Apr 2024 | Recall initiated by company | |
| 7 May 2024 | Classified by FDA | +12 days |
| 15 May 2024 | Published in enforcement report | +8 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: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
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 bottles (NDC 64980-514-05), and b) 15 mL bottles (NDC 64980-514-15), Rx only, Manufactured by: FDC Limited, Maharashtra, India, Distributed by: Rising Pharmaceuticals, Inc, NJ
Where it was distributed
New Jersey Only
Questions about this recall
Is Timolol Maleate Ophthalmic Solution, USP, 5% recalled?
Yes. FDC recalled Timolol Maleate Ophthalmic Solution, USP, 5% on 25 Apr 2024. The recall is Class II and its status is Terminated. Recall number D-0488-2024.
Why was it recalled?
Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
Which lots are affected?
Lot #: a) 083H008, Exp. Date 07/2025; 083G003, Exp. Date 06/2025; 083J017, Exp. Date 09/2025; b) 083I013, Exp. Date 08/2025.
Where was it sold?
New Jersey Only
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 |