The Recall Desk

Manufacturer

FDC Limited

11 recalls in our database name FDC Limited as the manufacturing or recalling firm.

What the numbers show

Total
11
Critical
0
Severe
0
Most recent
2025-08-06

Of the 11 recalls from FDC Limited we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 0 (0%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–11 of 11

  • ModerateFDA (Drugs)·D-0543-2025·2025-08-06

    Timolol eye drop caps can lodge a spike in the nozzle

    Timolol Maleate Ophthalmic Solution USP 0.5% is being recalled because of a defective container: the spike of the cap becomes lodged in the nozzle of the bottle. 154,176 bottles affected.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0403-2025·2025-05-14

    Timolol Maleate Ophthalmic Solution Recalled for Defective Container

    FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% due to a defective container where the spike of the cap becomes lodged in the bottle nozzle, preventing users from accessing the solution.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0282-2025·2025-03-26

    Ciprofloxacin Ophthalmic Solution Recalled Nationwide for Defective Container Cap

    Ciprofloxacin Ophthalmic Solution is being recalled because the cap spike is lodged in the bottle nozzle, preventing patients from accessing the medication. Affected lot 084A067 was distributed nationwide.

    Product
    CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0214-2025·2025-02-12

    Timolol Maleate eye drops recalled for defective dropper cap

    FDC Limited is recalling Timolol Maleate ophthalmic solution because the dropper cap spike may become lodged in the bottle nozzle, preventing access to the medication. The recall affects one lot distributed to a single U.S. distributor in New Jersey.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0182-2025·2025-01-15

    Ciprofloxacin Ophthalmic Eye Drops Recalled Due to Defective Container

    FDC Limited is recalling 136,181 bottles of Ciprofloxacin Ophthalmic Solution due to defective packaging where the cap spike is lodged in the bottle nozzle, preventing product dispensing.

    Product
    CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0114-2025·2024-12-18

    Ophthalmic Eye Drops Recalled for Defective Container Cap Spike

    FDC Limited is recalling Timolol Maleate eye drops (0.25%, 15mL bottles) due to a defective cap design where the spike may lodge in the bottle nozzle, preventing patients from dispensing the medication.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0035-2025·2024-11-13

    Timolol Maleate Eye Drops Recalled Due to Defective Container

    FDC Limited is recalling 155,232 bottles of Timolol Maleate Ophthalmic Solution due to a defective cap spike that becomes lodged in the nozzle, preventing medication dispensing.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state
  • ModerateFDA (Drugs)·D-0642-2024·2024-08-28

    FDA recalls Timolol Maleate eye drops due to defective bottle cap

    FDC Limited recalls Timolol Maleate Ophthalmic Solution nationwide because the bottle cap spike becomes lodged in the nozzle, preventing patients from dispensing the medication. No illnesses have been reported.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0632-2024·2024-08-21

    Ophthalmic solution recalled for defective container with lodged spike

    FDC Limited recalls Timolol Maleate eye drops (362,544 bottles) nationwide due to a manufacturing defect: a yellow spike from the cap lodged in the nozzle, posing a risk of eye injury.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0623-2024·2024-08-07

    Ciprofloxacin Ophthalmic Solution Recalled Due to Defective Container

    FDC Limited is recalling 66,528 bottles of Ciprofloxacin ophthalmic solution USP 0.3% due to a manufacturing defect in the container cap that prevents access to the medication. All affected bottles were distributed nationwide.

    Product
    CIPROFLOXACIN — CIPROFLOXACIN (CIPROFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0488-2024·2024-05-15

    Timolol Maleate ophthalmic solution recalled for defective container cap nozzle

    FDC Limited is recalling Timolol Maleate Ophthalmic Solution 0.5% distributed in New Jersey due to defective bottle caps with yellow spikes that can lodge in the nozzle, posing a risk of eye injury.

    Product
    TIMOLOL MALEATE — TIMOLOL MALEATE (TIMOLOL MALEATE)
    Category
    Drug
    Distribution
    1 state