FDC Limited
Complete recall history across all FDA and CPSC categories — 11 total recalls
FDC Limited appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (11)
FDA drug safety enforcement actions by FDC Limited
| Date | Product | Reason | Class |
|---|---|---|---|
| Jul 5, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective Container: spike of the cap becomes lodged in the nozzle of the pro... | Class II |
| Apr 18, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 10mL bottles, Rx only... | Defective Container: Unable to get the solution out of the bottle as the spik... | Class II |
| Mar 11, 2025 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, package in 5 mL bottles,... | Defective container: Unable to get the solution out of the bottle as the spik... | Class II |
| Jan 23, 2025 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective Container: Unable to get the solution out of the bottle as the spik... | Class II |
| Dec 16, 2024 | Ciprofloxacin Ophthalmic Solution USP, 0.3% as base, Sterile, package in 5 mL... | Defective container: Unable to get the solution out of the bottle as the spik... | Class II |
| Dec 5, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.25%, Sterile, 15mL bottles, Rx onl... | Defective Container: Unable to get the solution out of the bottle as the spik... | Class II |
| Oct 29, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective Container: Unable to get the solution out of the bottle as the spik... | Class II |
| Aug 12, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, packaged in: a) 5mL bottle (ND... | Defective Container: patients are unable to get the solution out of the bottl... | Class II |
| Jul 23, 2024 | Ciprofloxacin ophthalmic solution USP, 0.3% as base, package in bottles: a) 1... | Defective container: unable to get the solution out of the bottle as the spik... | Class II |
| Jul 18, 2024 | Timolol Maleate Ophthalmic Solution USP, 0.5%, Sterile, 5mL bottles, Rx only,... | Defective container; yellow colored spike from cap lodged in the nozzle | Class II |
| Apr 25, 2024 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, packaged in a) 5mL bottles (N... | Defective Container: yellow-colored spike from cap lodged in the nozzle. Firm... | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious — there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious — the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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