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1 | Cited products are: | Tally of products cited in: | Tally of notices: | ||||||||||||||||||||||||||||||
2 | Date of notice or recall | Notice type & Link | Company (-ies) | Location | Affected product(s) | FDA Listed | Not FDA Listed | Total | Warning Letter - Distributor | Public Warning | Product Recall | [duplicated in recent recall] | Warning Letter - Manufacturer | [duplicated in recent letter or warning] | Recall notices or amendments | Warning Letters - Distributor | Warning Letters - Manufacturer | Public Warning or PSN | Product recall notice | ||||||||||||||
3 | 2022 TO 2026 TOTALS | 258 | 104 | 321 | 102 | 34 | 196 | 8 | 27 | 41 | 12 | 37 | 22 | 4 | 23 | ||||||||||||||||||
4 | 2026 Notices / Actions / Recalls | 117 | 1 | 118 | 0 | 0 | 116 | 0 | 2 | 0 | 0 | 0 | 5 | 0 | 15 | ||||||||||||||||||
5 | |||||||||||||||||||||||||||||||||
6 | Oct-05-2026 | [Recall classification - no public notice] | KC Pharmaceuticals | USA (CA) | 8 generic lubricating and redness reilever eye drops under multiple brands | 8 | 8 | 8 | |||||||||||||||||||||||||
7 | Sep-28-2026 | [Recall classification - no public notice] | Aurolab Trust (for Covalent) | India | Focus PI 82724-007-19 | 1 | 1 | 1 | |||||||||||||||||||||||||
8 | Sep-21-2026 | [Recall classification - no public notice] | Sterling Pharmaceutical | USA (IL) | 9 generic lubricant eye drops and ointments under AvKare, Walgreens, TRP, Reliable, Major and Cameron labels | 9 | 9 | 9 | 9 | ||||||||||||||||||||||||
9 | Sep-15-2026 | Warning Letter(Manufacturer) | Bausch & Lomb Inc | USA (FL) | Warning Letter does not identify products. 48 prescription and 14 OTC Bausch brand drugs are manufactured at this location according to DailyMed. Details | 1 | |||||||||||||||||||||||||||
10 | Sep-01-2026 | Warning Letter(Manufacturer) | PREye | USA (CO) | Vitamin SEE | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
11 | Aug-18-2026 | Warning Letter(Manufacturer) | KC Pharmaceuticals | USA (CA) | 1 | ||||||||||||||||||||||||||||
12 | Aug-14-2026 | [Recall classification - no public notice] | Prestige Brand Holdings | Clear Eyes Maximum Itchy Eye Relief | 1 | 1 | 1 | ||||||||||||||||||||||||||
13 | Jul-23-2026 | [Recall classification - no public notice] | Rohto-Mentholatum | Vietnam | Rohto Cooling Eye Drops All-in-One; Rohto Cooling Eye Drops Max Strength; Rohto Cooling Eyey Drops Optic Glow; Rohto Cooling Eye Drops Digi Eye; Rohto Cooling Eye Drops Dry Aid; Rohto Cooling Eye Drops Cool Relief | 8 | 8 | 8 | Sinced | ||||||||||||||||||||||||
14 | Jun-25-2026 | Warning Letter(Manufacturer) | Excelvision Fareva | France | Does not identify products. This is their 2nd Warning Letter in 2 years. This is the company that manufactured the products recalled on April 23 through 27 2026. | 1 | |||||||||||||||||||||||||||
15 | May-18-2026 | [Recall classification - no public notice] | PREye | Colorado | Vitamin SEE | 1 | 1 | 1 | |||||||||||||||||||||||||
16 | Apr-27-2026 | [Recall classification - no public notice] | Oasis | Glendora CA | Oasis Tears (multi-dose preservative-free bottle) 3 lots | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
17 | Apr-28-2026 | [Recall classification - no public notice] | Thea Pharma | France | Ivizia | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
18 | Apr-28-2026 | [Recall classification - no public notice] | Scope Health | France | Optase Dry Eye Intense (multi-dose preservative-free bottle) 15 lots | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
19 | Apr-24-2026 | [Recall classification - no public notice] | Alcon | France | Genteal Gel - all unexpired lots | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
20 | Apr-24-2026 | [Recall classification - no public notice] | Alcon | France | Systane Gel - all unexpired lots | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
21 | Apr-23-2026 | [Recall classification - no public notice] | Harrow | France | Freshkote | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
22 | Mar-31-2026 | [Recall classification - no public notice] | KC Pharmaceuticals | Pomona, CA | 82 dry eye and redness reliever drops (8 distinct products under 28 different brand labels) | 82 | 0 | 82 | 82 | ||||||||||||||||||||||||
23 | Mar-20-2026 | Warning Letter(Manufacturer) | RC Outsourcing LLC | USA (OH) | Povidone-Iodine Sterile Ophthalmic Solution | 1 | 1 | 1 | 1 | ||||||||||||||||||||||||
24 | 2025 Notices / Actions / Recalls | 19 | 27 | 46 | 39 | 0 | 5 | 0 | 0 | 1 | 0 | 20 | 3 | 0 | 1 | ||||||||||||||||||
49 | 2024 Notices / Actions / Recalls | 15 | 23 | 38 | 23 | 3 | 7 | 0 | 5 | 2 | 3 | 5 | 7 | 1 | 7 | ||||||||||||||||||
50 | Dec-21-2024 | Recall Notice | Alcon | Systane Ultra (1 lot) | 1 | 0 | 1 | 1 | 1 | ||||||||||||||||||||||||
51 | Oct-24-2024 | Warning Letter [Distributor] | Fancy Drops Beauty LLC | Fancy Drops eye drops (10 colors) | 0 | 10 | 10 | 1 | |||||||||||||||||||||||||
52 | Oct-02-2024 | Warning Letter [Manufacturer] | Omni Lens Pvt Ltd | India | Vista Gonio Eye Lubricant, NDC 77790-022 | 1 | 0 | 1 | 1 | ||||||||||||||||||||||||
53 | Aug-16-2024 | Warning Letter [Manufacturer] | Regenerative Processing Plant | USA (FL) | Regener-Eyes Lite, Regener-Eyes Pro | 2 | 0 | 2 | 1 | ||||||||||||||||||||||||
54 | Jul-17-2024 | Warning Letter [Distributor] | Velocity Pharma | Names brands not products; products previously recalled | 0 | 0 | 1 | ||||||||||||||||||||||||||
55 | Jul-11-2024 | Warning Letter [Manufacturer] | Brassica Pharma | India | Does not identify products | 0 | 0 | 1 | |||||||||||||||||||||||||
56 | Jun-20-2024 | Warning Letter [Manufacturer] | Optikem International | USA (CO) | Extensive CGMP violations for homeopathic drops. | 0 | 0 | 1 | |||||||||||||||||||||||||
57 | Mar-28-2024 | Warning Letter [Manufacturer] | Killitch | India | Multi-Action Relief Drops; Equate Hydration | 2 | 0 | 2 | 1 | ||||||||||||||||||||||||
58 | Feb-22-2024 | Recall Notice | Brassica Pharma; 3 brands, 4 products | Walmart/Equate, CVS and AACE | 4 | 0 | 4 | 1 | 4 | ||||||||||||||||||||||||
59 | Feb-15-2024 | Warning Letter [Manufacturer] | LightEyez Limited | UK | Color changing eye drops and some MSM. More than 10 (FDA states "including but not limited to" - company sells very large number of products) "Repair" product was subject to Public Warning in August 2023. | 0 | 10 | 10 | 1 | 1 | 1 | ||||||||||||||||||||||
60 | Feb-14-2024 | Warning Letter [Manufacturer] | Amman Pharmaceutical Industries | Jordan | Extensive CGMP violations. Products not named, but letter states they will all be recalled. | 0 | 0 | 0 | 1 | ||||||||||||||||||||||||
61 | Feb-13-2024 | Warning Letter [Distributor] | Ezricare LLC | Recalled 2/2/23 | 1 | 0 | 1 | 1 | 1 | ||||||||||||||||||||||||
62 | Feb-13-2024 | Warning Letter [Distributor] | Delsam Pharma | Recalled 2/2/23 and 2/24/23 | 2 | 0 | 2 | 1 | |||||||||||||||||||||||||
63 | Jan-31-2024 | Public Warning | Unknown | South Moon, Rebright, Fivfivgo | 0 | 3 | 3 | 1 | |||||||||||||||||||||||||
64 | Jan-19-2024 | Recall Amendment | Killitch; Rite Aid | 2 Rite Aid lubricant drops | 2 | 0 | 2 | 1 | 2 | ||||||||||||||||||||||||
65 | 2023 Notices / Actions / Recalls | 107 | 50 | 157 | 38 | 31 | 68 | 8 | 17 | 38 | 9 | 10 | 4 | 3 | |||||||||||||||||||
66 | Dec-05-2023 | Warning Letter [Distributor] | Belmont Eyecare | Colloidal silver, MSM, Organic Daytime Oil, Organic Evening Oil | 6 | 6 | 1 | ||||||||||||||||||||||||||
67 | Nov-28-2023 | Warning Letter [Distributor] | Dr. Berne's | Also recalled - see 8/30/23 notice | 3 | 3 | 1 | ||||||||||||||||||||||||||
68 | Nov-15-2023 | Recall Notice | Kilitch Healthcare; 7 brands | 8 (Rugby, Leader) also subject to 11/1/23 distributor recalls | 27 | 27 | 8 | 27 | 1 | ||||||||||||||||||||||||
69 | Nov-14-2023 | Warning Letter [Distributor] | Amazon | Of the 7 products listed, Optique-1, Can-C, TRP, Similasan and Oclumed also named in individual Warning Letters 9/11/23 GOODBYE AND MANZANILLA are th eonly ones unique to Amazon | 3 | 4 | 7 | 5 | 1 | ||||||||||||||||||||||||
70 | Nov-14-2023 | Warning Letter [Manufacturer] | Global Pharma | India | (previously recalled - see 2/2/23) | 3 | 3 | 3 | 1 | ||||||||||||||||||||||||
71 | Nov-01-2023 | Recall Notice | The Harvard Drug Group | (also subject to 10/27 warning) | 2 | 2 | 1 | ||||||||||||||||||||||||||
72 | Nov-01-2023 | Recall Notice | Cardinal Health | (5 also subject to 10/27 warning) Leader Lubricant Eye Drops - Propylene Glycol, plus 5 on 10/27 FDA warning | 6 | 6 | 1 | ||||||||||||||||||||||||||
73 | Oct-27-2023 | Public Warning | Multiple | 27 | 27 | 1 | |||||||||||||||||||||||||||
74 | Sep-11-2023 | Warning Letter [Distributor] | TRP | 10 | 10 | 1 | |||||||||||||||||||||||||||
75 | Sep-11-2023 | Warning Letter [Distributor] | Natural Ophthalmics | 6 | 6 | 1 | |||||||||||||||||||||||||||
76 | Sep-11-2023 | Warning Letter [Distributor] | CVS Health | 1 | 1 | 1 | |||||||||||||||||||||||||||
77 | Sep-11-2023 | Warning Letter [Distributor] | Boiron Inc | 1 | 1 | 1 | |||||||||||||||||||||||||||
78 | Sep-11-2023 | Warning Letter [Distributor] | Dr Vitamins LLC | Vision clarity, life extension can c longevity science. Bought Can-C 4/15/23 | 1 | 3 | 4 | 1 | |||||||||||||||||||||||||
79 | Sep-11-2023 | Warning Letter [Manufacturer] | Similasan | Switzerland | 12 | 12 | 1 | ||||||||||||||||||||||||||
80 | Sep-11-2023 | Warning Letter [Distributor] | Walgreens | 3 | 3 | 1 | |||||||||||||||||||||||||||
81 | Sep-11-2023 | Warning Letter [Distributor] | OcluMed | USA (PA) | 1 | 1 | 1 | ||||||||||||||||||||||||||
82 | Aug-29-2023 | Warning Letter [Manufacturer] | KC Pharmaceuticals | USA (CA) | Products not listed in Warning Letter | 0 | 0 | 1 | |||||||||||||||||||||||||
83 | Aug-30-2023 | Recall Notice | Dr. Sam Berne | MSM 5%, MSM 15% | 3 | 3 | 1 | ||||||||||||||||||||||||||
84 | Aug-22-2023 | Public Warning | LightEyez | LightEyez MSM Eye Drops - Eye Repair | 1 | 1 | 1 | ||||||||||||||||||||||||||
85 | Jun-13-2023 | Recall D-0898-2023 [No public notice] | KC Pharmaceuticals | 9 | 9 | 1 | |||||||||||||||||||||||||||
86 | Jun-13-2023 | Recall D-0897-2023 [No public notice] | KC Pharmaceuticals | 17 | 17 | 1 | |||||||||||||||||||||||||||
87 | Apr-28-2023 | Warning Letter [Manufacturer] | Pharmedica | USA (AZ) | MSM. Also recalled, see 3/3/23 notice) | 1 | 1 | 1 | |||||||||||||||||||||||||
88 | Apr-10-2023 | Public Safety Notification | Regener-Eyes; M2 Biologics | Amniotic fluid. Regener-Eyes (Lite, Pro); StimulEyes | 2 | 1 | 3 | 1 | |||||||||||||||||||||||||
89 | Mar-03-2023 | Recall Notice | Pharmedica | MSM. Non-sterility. | 1 | 1 | 1 | ||||||||||||||||||||||||||
90 | Feb-24-2023 | Recall Notice | Global Pharma | Delsam Pharma Artificial Eye Ointment | 1 | 1 | 1 | ||||||||||||||||||||||||||
91 | Feb-02-2023 | Recall Notice | Global Pharma | Ezricare & Delsam Pharma Artificial Tears. Also of note: CDC notice - Multi-state cluster of Pseudomonas aeruginosa infections associated with permanent loss of vision and loss of life. | 2 | 2 | 1 | ||||||||||||||||||||||||||
92 | 2022 Notices / Actions / Recalls | 0 | 3 | 3 | 2 | 0 | 0 | 0 | 3 | 0 | 0 | 2 | 3 | 0 | |||||||||||||||||||
93 | Oct-04-2022 | Warning Letter [Manufacturer] | Sterling Pharmaceutical | USA (IL) | 1 | 1 | |||||||||||||||||||||||||||
94 | Aug-09-2022 | Warning Letter [Manufacturer] | Vitti Labs | USA (MO) | 1 | 1 | 1 | ||||||||||||||||||||||||||
95 | Feb-15-2022 | Warning Letter [Distributor] | Glenn Burkett Naples Corporation | 1 | 1 | 1 | |||||||||||||||||||||||||||
96 | Feb-08-2022 | Warning Letter [Distributor] | New Earth Healing Essentials LLC | USA (VT) | 1 | 1 | 1 | ||||||||||||||||||||||||||
97 | Jan-11-2022 | Warning Letter [Manufacturer] | Hubei Kangzheng Pharmaceutical | China | Note: They claimed to FDA that their eye drops didn't have to be sterile | 1 | 1 | ||||||||||||||||||||||||||
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