FDC recalls

FDC has 11 recalls on record with the FDA and USDA, the earliest in 2024 and the latest reported on 6 Aug 2025. 10 are still ongoing.

Total recalls11since 2024

Last 12 months0reported

Class I00% of total

Ongoing10latest 6 Aug 2025

Recalls per month, last 24 months

click a bar for that month

1Nov '24 1 1 1Feb 1 0 1May 0 0 1Aug 0 0 0Nov 0 0 0Feb 0 0 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 11 100%Class III 0 0%

By year

2025545%
2024655%

Ongoing fdc recalls

10 active

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
14 May 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
26 Mar 2025Drug	CLASS II	Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalledCiprofloxacin	FDC	Packaging Defects	Nationwide
12 Feb 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
15 Jan 2025Drug	CLASS II	Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin	FDC	Packaging Defects	Nationwide
18 Dec 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ

All fdc recalls, newest first

11 total

Reported	Class	Recall	Company	Reason	Where
6 Aug 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
14 May 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
26 Mar 2025Drug	CLASS II	Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package recalledCiprofloxacin	FDC	Packaging Defects	Nationwide
12 Feb 2025Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
15 Jan 2025Drug	CLASS II	Ciprofloxacin Ophthalmic Solution USP, 0.3% as base recalled by FDCCiprofloxacin	FDC	Packaging Defects	Nationwide
18 Dec 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
13 Nov 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	NJ
28 Aug 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate	FDC	Packaging Defects	Nationwide
21 Aug 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile recalled by FDCTimolol Maleate	FDC	Other	Nationwide
7 Aug 2024Drug	CLASS II	Ciprofloxacin ophthalmic solution USP, 0.3% as base recalled by FDCCiprofloxacin	FDC	Packaging Defects	Nationwide
15 May 2024Drug	CLASS II	Timolol Maleate Ophthalmic Solution recalled by FDCTimolol Maleate	FDC	Packaging Defects	NJ

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.

Severity split

Why fdc is recalled

Product types

Brands

By year

About this list