Aurangabad, Maharashtra State, India
FDC Limited recalls
11 recalls recorded since 2018, most recently on 5 July 2025. 10 are listed as ongoing. Status and classification are as published by the FDA.
Recalls11
Ongoing (FDA)10
Terminated or completed1
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 5 July 2025
- Reason
- Defective Container: spike of the cap becomes lodged in the nozzle of the product bottle.
- Distribution
- U.S Nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0543-2025
- 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.
Ongoing Class II Drugs
- Recall started
- 18 April 2025
- Reason
- 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.
- Distribution
- U.S. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0403-2025
- 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
Ongoing Class II Drugs
- Recall started
- 11 March 2025
- Reason
- 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
- Distribution
- Nationwide in the U.S
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0282-2025
- Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Ongoing Class II Drugs
- Recall started
- 23 January 2025
- Reason
- 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.
- Distribution
- Distributed to one (1) Us Distributor in NJ
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0214-2025
- 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.
Ongoing Class II Drugs
- Recall started
- 16 December 2024
- Reason
- 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
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0182-2025
- Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL bottles, Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited, Maharashtra, India, NDC 69315-308-05
Ongoing Class II Drugs
- Recall started
- 5 December 2024
- Reason
- 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.
- Distribution
- Distributed to one Us Distributor in NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0114-2025
- Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx only, Manufactured by: FDC Limited, Waluj, Aurangabad, Maharashtra, India, Distributed by: Rising Pharmaceuticals Inc, New Jersey, NDC 64980-513-1
Ongoing Class II Drugs
- Recall started
- 29 October 2024
- Reason
- 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
- Distribution
- Distributed to one Us Distributor in NJ.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0035-2025
- 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.
Ongoing Class II Drugs
- Recall started
- 12 August 2024
- Reason
- 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.
- Distribution
- Nationwide U.S.A.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0642-2024
- 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
Ongoing Class II Drugs
- Recall started
- 23 July 2024
- Reason
- 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.
- Distribution
- U.S. A. Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0623-2024
- Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 10 mL (NDC 69315-308-10), b) 2.5 mL (NDC 69315-308-02), Rx Only, Distributed by: Leading Pharma LLC, Fairfield, NJ. Manufactured by: FDC Limited
Ongoing Class II Drugs
- Recall started
- 18 July 2024
- Reason
- Defective container; yellow colored spike from cap lodged in the nozzle
- Distribution
- Nationwide in the US
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0632-2024
- 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
Terminated Class II Drugs
- Recall started
- 25 April 2024
- Terminated
- 21 May 2026
- Reason
- Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm received several complaints from customers.
- Distribution
- New Jersey Only
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0488-2024
- 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 Ph
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.