FDA Eye Drop Recall 2026: Check Rohto, Store Brands & Lot Numbers
Joe
Rugby Laboratories | Walgreens | CVS | GoodSense | Geri-Care
15 minute read
Table of Contents
- How to Check Your Eye Drop Lot Number
- Popular FDA Eye Drop Recall Status Questions
- FDA Eye Drop Recall 2026 Master List (FDA Event 98533)
- Safe Alternative Eye Drops In Stock
- What Is a Voluntary FDA Recall?
- Official FDA Eye Drop Recall Sources
- Related Eye Care and Recall Guides
- About Xeteor
- Historical Archive: Past FDA Eye Drop Recalls
- Frequently Asked Questions
In 2026, a major FDA eye drop recall wave and related supply shortages affected millions of over-the-counter and prescription bottles nationwide. Major recalls due to sterility concerns include over-the-counter store brands manufactured by K.C. Pharmaceuticals (such as GoodSense, Rugby Laboratories, Geri-Care, CVS Health, Walgreens, Publix, Kroger, and Leader), nearly 12 million cartons of Rohto Cooling Eye Drops, and prescription Lupin Prednisolone Acetate 1%. High demand for safe alternatives has also caused widespread retail shortages for popular brand-name drops like Clear Eyes.
⚠️ August 2026 Update: Nationwide OTC & Prescription Eye Drop Recall Status
Major OTC Eye Drop Recalls: Active recalls due to lack of assurance of sterility cover both store-brand and major brand products:
- Store-Brand Generics (K.C. Pharmaceuticals): Affects specific lots of GoodSense, Rugby Laboratories, Geri-Care, CVS Health, Walgreens, Kroger, Publix, Leader, and Dollar General.
- Rohto Cooling Eye Drops: Affects specific cartons of Rohto brand cooling and redness-relief formulas due to sterility concerns. Check your lot number before use.
Clear Eyes & Brand-Name Shortages: Brand-name drops like Clear Eyes, Systane, and Refresh are manufactured in separate, unaffected facilities. However, heavy consumer demand from displaced store-brand buyers has caused widespread retail shortages of Clear Eyes nationwide.
Separate Rx-Only Recall: A separate recall involves Lupin Prednisolone Acetate Ophthalmic Suspension, USP, 1%, an Rx-only steroid eye drop. Patients should contact their pharmacist, prescriber, or eye doctor about recalled prescription eye drops. OTC lubricant, redness-relief, or allergy eye drops are not replacements for prescription steroid eye drops.
For licensed pharmacy professionals: Republic Pharmaceuticals has published a separate professional resource about Amneal Prednisolone Acetate Ophthalmic Suspension 1% NDC information after the Lupin recall: Republic professional pharmacy resource.
Eye safety warning: If you are experiencing eye pain, discharge, worsening redness, blurry vision, vision changes, recent eye surgery, eye injury, or infection concerns, contact a doctor or eye care professional immediately.
This recall page is part of our Eye Care Hub, where we track eye drop recalls, dry eye alternatives, allergy eye drops, and store-brand eye care updates.
⚠️ OTC eye drops are not replacements for prescription steroid eye drops
If you have a recalled bottle of prednisolone acetate ophthalmic suspension 1%, do not replace it with an over-the-counter lubricant, allergy, or redness-relief eye drop unless your eye doctor, prescriber, or pharmacist tells you to. Prescription steroid eye drops are used for specific inflammatory eye conditions and should be managed by a healthcare professional.
If you have eye pain, discharge, worsening redness, blurry vision, vision changes, recent eye surgery, eye injury, or infection concerns, contact an eye care professional right away.
Some visitors arrive on this page because they saw eye drop recall news and are trying to figure out whether an OTC eye drop or eye care product may fit their situation. The table below separates prescription-recall questions, brand-name shortages, and recalled products from common over-the-counter comfort options.
| If You Are Searching For... | Best Route | Xeteor Option | Important Note |
|---|---|---|---|
| Lupin prednisolone acetate eye drop recall Rx-only steroid eye drop | Contact your pharmacy, prescriber, or eye doctor | No OTC substitute listed Licensed pharmacy professionals can review the Republic professional pharmacy resource. | OTC drops are not replacements for prescription steroid eye drops. |
| Rohto eye drop recall Naphazoline HCl + Lubricant | Allergy itch relief or Lubricating tears | GoodSense Eye Itch Relief 3-Pack or Reliable 1 Lubricating Tears | Check Rohto lots on the FDA database. OTC options provide non-menthol comfort. |
| Clear Eyes out of stock / recall questions Retail shortage inquiry | Everyday dry eye or allergy drops | Reliable 1 Lubricating Tears Eye Drops - 3 Pack | Clear Eyes is not recalled; store shortages are due to high demand. |
| PreserVision AREDS 2 recall or stockout questions Oral macular health vitamin | Generic AREDS 2 oral supplement | GoodSense SuperView2 (2-Pack) | Oral supplement, not an eye drop. Matches core AREDS 2 antioxidants with 20 mg daily zinc. |
| Dry, irritated, or gritty-feeling eyes Not replacing an Rx steroid | Preservative-free lubricant eye drops | GoodSense Lubricating Plus Preservative-Free Eye Drops - 4 Pack | A Refresh Plus-style OTC comfort option for dryness. |
| Everyday dry eye relief Bottle format | Lubricating tears | Reliable 1 Lubricating Tears Eye Drops - 3 Pack | A Refresh Tears-style route for everyday dry eye comfort. |
| Allergy-related itchy eyes No pain or vision changes | Ketotifen allergy eye drops | GoodSense Eye Itch Relief Ketotifen 0.025% - 3 Pack | A Zaditor-style OTC option for allergy itch relief. |
| Eye pain, discharge, blurry vision, vision changes, injury, surgery, or infection concerns | Medical care | Do not self-route to OTC drops | Contact an eye care professional promptly. |
How to Check Your Eye Drop Lot Number
If you have a bottle of Geri-Care, GoodSense, CVS Health, Rugby Laboratories, Walgreens, or another store-brand listed below, check the lot number and expiration date to see if your specific bottle is affected.
- Find the lot number: Look on the bottom flap of the box or on the side of the bottle label. It may be printed near the barcode.
- Compare the first characters: The code may look like LOT: LT24E01. Compare the beginning of your lot number to the affected lot prefixes in the table below.
- Stop using matched lots: If your lot starts with one of the recalled prefixes, do not use the drops.
⚠️ What to do if your bottle is recalled:
Do not put the drops in your eyes. Throw the bottle away or return it to the pharmacy where you purchased it. If you are experiencing eye pain, redness, discharge, blurry vision, or vision changes, contact an eye care professional immediately.
Popular FDA Eye Drop Recall Status Questions
| Search Question | Quick Answer |
|---|---|
| Systane eye drops recall 2026 | Brand-name Systane is different from the recalled store-brand products listed below. Some Systane-style generics, including earlier GoodSense and Rugby lots, were affected. For the latest substitution guide, see our Systane Ultra Generic Alternatives page. |
| GoodSense eye drops recall | Earlier GoodSense lots are included in the recall table below. Xeteor’s current GoodSense Ultra inventory has been verified by GoodSense as not affected by the recall. Older bottles should still be checked by lot number. |
| Rugby eye drops recall | Rugby Lubricating Eye Drops - 0.5 fl oz appear in the recall table below. Check the lot prefix before using any older bottle. |
| Refresh eye drops recall 2026 | Refresh brand products are different from the K.C. Pharmaceuticals store-brand products listed below. If you are using a store-brand Refresh-style product, check the exact brand and lot number. For alternatives, see our Refresh Tears Generic Alternatives guide. |
| Zaditor, Alaway, Lumify, Clear Eyes recall questions | Check the exact product and lot number. Some store-brand eye drops are affected, but not every eye drop brand or formula is part of this recall. For allergy itch relief alternatives, see our Zaditor Generic Alternatives guide. |
| Bausch & Lomb eye wash recall | Bausch & Lomb Eye Wash is a different eye wash product and is not shown in the K.C. Pharmaceuticals recall table below. If you are looking for an available eye wash option, see McKesson Eye Wash Ophthalmic Solution. |
FDA Eye Drop Recall 2026 Master List (FDA Event 98533)
Recall Summary: This FDA recall is classified as Class II and was initiated due to lack of assurance of sterility.
The table below is designed as a quick consumer check tool. It highlights commonly encountered recalled products and the lot prefix to look for first on the box or bottle.
| Brand / Distributor | Exact Product Description | NDC / UPC Number | Recall # | Affected Lot Prefix Check First Characters |
|---|---|---|---|---|
| Best Choice | Sterile Eye Drops AC / Irritation Relief | UPC 0-70038-47010-6 | D-0409-2026 | AC24E |
| QC-Quality Choice | Sterile Eye Drops AC / Irritation Relief | NDC 83324-190-14 | D-0409-2026 | AC24E |
| Walgreens | Eye Drops Advanced Relief | UPC 3-11917-20074-3 | D-0410-2026 | AR24D, AR24G, AR24M |
| Kroger | Eye Drops Advanced Relief | See Box for UPC | D-0410-2026 | AR24D, AR24G, AR24M |
| CVS Health | Eye Drops Advanced Relief | UPC 0-50428-43544-1 | D-0410-2026 | AR24D, AR24G, AR24M |
| Geri-Care | Artificial Tears (Dry Eye Relief) | NDC 57896-181-05 | D-0411-2026 | LT24E, LT24F, LT24G, LT24M |
| TopCare Health | Artificial Tears (Dry Eye Relief) | UPC 0-36800-36100-3 | D-0411-2026 | LT24E, LT24F, LT24G, LT24M |
| Leader | Ultra Lubricating Eye Drops | NDC 70000-0457-1 | D-0412-2026 | SU24E, SU24K |
| Harris Teeter | Ultra Lubricating Eye Drops | UPC 0-72036-73588-1 | D-0412-2026 | SU24E |
| GoodSense | Ultra Lubricating Eye Drops | NDC 50804-160-01 | D-0412-2026 | SU24E |
| GoodSense | Sterile Eye Drops Original Formula | NDC 50804-141-01 | D-0413-2026 | RG24E, RG24G |
| Dollar General | Sterile Eye Drops Original Formula | See Box for UPC | D-0413-2026 | RG24E, RG24G |
| Circle K | Sterile Eye Drops Original Formula | See Box for UPC | D-0413-2026 | RG24E, RG24G |
| Kroger | Sterile Eye Drops Original Formula | See Box for UPC | D-0413-2026 | RG24E, RG24G |
| CVS Health | Sterile Eye Drops Original Formula | See Box for UPC | D-0413-2026 | RG24E, RG24G |
| Industrial Eye Relief (Cintas) | Sterile Eye Drops Redness Lubricant | UPC 130209 | D-0414-2026 | RL24D, RL24F |
| Good Neighbor Pharmacy (GNP) | Eye Drops, Redness & Dry Eye Relief | NDC 46122-606-05 | D-0414-2026 | RL24F |
| Rugby | Soothing Tears / Lubricating Eye Drops | NDC 0536-1219-94 | D-0415-2026 | SY24K |
| Walgreens | Soothing Tears / Lubricating Eye Drops | UPC 3-11917-20300-3 | D-0415-2026 | SY24K |
| Leader | Artificial Tears Sterile Lubricant | NDC 70000-0011-1 | D-0416-2026 | AT24D, AT24E, AT24G |
| GoodSense | Artificial Tears Sterile Lubricant | NDC 50804-110-01 | D-0416-2026 | AT24D, AT24E, AT24G |
| Publix | Artificial Tears Sterile Lubricant | UPC 0-41415-00976-9 | D-0416-2026 | AT24E |
| TopCare Health | Artificial Tears Sterile Lubricant | UPC 0-36800-09331-7 | D-0416-2026 | AT24D, AT24E, AT24G |
| Good Neighbor Pharmacy (GNP) | Artificial Tears Sterile Lubricant | NDC 24385-006-05 | D-0416-2026 | AT24D, AT24E, AT24G |
How to use this table: Start by checking the product name and brand, then compare the first characters of the lot number on your box or bottle.
Note: Full lot numbers may include extra digits after the prefix. For example, if the recalled prefix is AC24E, a full lot such as AC24E01 should be treated as affected. Additional store-brand products may also appear in the FDA master list.
Safe Alternative Eye Drops In Stock
If your bottle appears on the recall list above, the safest next step is to stop using that specific bottle and choose a current alternative that fits your eye drop type. Below are practical replacement routes from our Eye Care Hub.
- Systane Ultra-style lubricant:GoodSense Ultra 3-Pack is back in stock at Xeteor, with current inventory verified by GoodSense as not affected by the recall. Brand-name Systane Ultra is also available. See our Systane Ultra Generic Alternatives guide.
- Refresh-style lubricant:Reliable 1 Lubricating Tears 3-Pack uses Carboxymethylcellulose Sodium 0.5% for everyday dry eye relief. For a preservative-free Refresh Plus-style option, choose GoodSense Lubricating Plus Preservative-Free 4-Pack, or the brand-name Refresh Plus Single-Use Containers. You can also view the single bottle Reliable 1 Lubricating Tears option and our Refresh Tears Generic Alternatives guide.
- Rohto & redness-relief alternatives: For users looking to replace recalled Rohto Cooling Eye Drops, GoodSense Eye Itch Relief 3-Pack targets underlying allergy redness and itching, while Reliable 1 Lubricating Tears provides soothing, non-menthol comfort for everyday eye irritation.
- Preservative-free dry eye drops:Refresh Plus Single-Use Vials and GenTeal Tears Single-Use Vials are preservative-free options.
- Allergy eye itch relief:GoodSense Eye Itch Relief 3-Pack and GoodSense Eye Itch Relief use Ketotifen. You can also compare options in our Zaditor Generic Alternatives guide.
- Brand-name allergy option:Systane Zaditor Eye Itch Relief is an antihistamine eye drop for allergy-related itching.
- Corneal edema / Muro 128-style products: These are different from standard dry-eye lubricant drops. See our Muro 128 Generic Alternatives guide, including Rugby Sodium Chloride 5% Solution, Reliable 1 Sodium Chloride 5% Solution, and Rugby Sodium Chloride 5% Ointment.
- Eye wash: If you are looking for an eye wash option, see McKesson Eye Wash Ophthalmic Solution.
- Macular health vitamins (Oral softgels): Oral supplements are not eye drops, but if you are seeking generic AREDS 2 vitamins for daily eye health support, see GoodSense SuperView2 (2-Pack) or read our PreserVision AREDS 2 Generic Alternatives guide.
What Is a Voluntary FDA Recall?
According to the FDA, a recall is an action taken by a firm to remove a product from the market. Recalls may be conducted on a firm’s own initiative, by FDA request, or by FDA order. In this case, the recall is described as voluntary because the manufacturer initiated the removal of affected products.
The FDA classifies recalls based on risk. The 2026 eye drop recalls listed above are classified as Class II, which means use of or exposure to the product may cause temporary or medically reversible adverse health consequences, or the probability of serious adverse health consequences is remote. You can read the FDA’s official recalls background and definitions for more detail.
Official FDA Eye Drop Recall Sources
- Official FDA Enforcement Report Event 98533: Complete FDA database listing of affected products and lot numbers.
- CVS Health Official Recall Notice PDF
- Geri-Care / McKesson Official Recall Notice PDF
- FDA Recall Background and Definitions
Related Eye Care and Recall Guides
- PreserVision AREDS 2 Generic Alternatives
- Systane Ultra Generic Alternatives
- Refresh Tears Generic Alternatives
- Zaditor Generic Alternatives
- Muro 128 Generic Alternatives
- Store-Brand Cough Drop Recall List
- Webcol Alcohol Prep Pad Recall List
About Xeteor
Xeteor.com, founded in Las Vegas in 2018, is a trusted online store and healthcare product guide specializing in generic over-the-counter medicines, store-brand alternatives, blood glucose test strips, diabetic testing supplies, vitamins, and healthcare essentials.
We help shoppers find the right product when a brand name is too expensive, a store-brand label is confusing, insurance is not being used, or the product they usually buy is out of stock. For OTC products, our approach compares active ingredients, strengths, dosage forms, package sizes, manufacturers, pricing, availability, and fulfillment options. For diabetic testing supplies, we help customers compare meter compatibility, test strip type, expiration dating, package count, price per strip, and out-of-pocket value.
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- Tier 1 Premium Generics:GoodSense and Foster & Thrive.
- Tier 2 Standard Generics:Geri-Care, Reliable 1 Laboratories, Oncor Pharmaceuticals, and Health Star.
- Tier 3 Value Generics:Major Pharmaceuticals and Rugby Laboratories.
Many customers also come to Xeteor.com for affordable cash-pay diabetic testing supplies, especially blood glucose test strips, meters, lancets, control solution, and related diabetes supplies. Explore our Diabetes Management Guides, including guides for CareSens Test Strips, True Metrix Test Strips, and Original Bayer Contour Test Strips.
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For more plain-English comparisons, visit the Xeteor OTC & Diabetes Guides.
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Disclaimer: This content is for informational purposes only and is not a substitute for professional medical advice. Always read and follow the product label. If you have a medical question, ask your doctor, pharmacist, or other qualified healthcare professional.
Important: Xeteor.com sells over-the-counter products, diabetic testing supplies, vitamins, and healthcare essentials. We do not sell, dispense, or fulfill prescription medications. OTC generic comparisons are based on factors such as active ingredient, strength, dosage form, package size, labeling, availability, and practical use case. Diabetes testing supplies must be compatible with the meter or device being used. Inactive ingredients, packaging, taste, texture, sourcing, expiration dating, and fulfillment path can vary.
Historical Archive: Past FDA Eye Drop Recalls
The following information relates to closed or historical recalls. We maintain this archive so consumers can check older bottles they may still have stored in their medicine cabinets.
October 2023: Rugby, CVS, Rite Aid, and Target
On October 30, 2023, the FDA issued a recall for several over-the-counter eye drop products due to the potential risk of eye infections caused by bacterial contamination. As an authorized reseller of Rugby Laboratories, we notified our customers of the two specific Rugby formulas affected:
- Rugby Lubricating Tears Eye Drops (0.1% Dextran / 0.3% Hypromellose) 15 mL (NDC: 0536-1282-94)
- Rugby Polyvinyl Alcohol 1.4% Lubricating Eye Drops 15 mL (NDC: 0536-1325-94)
The 2023 recall also heavily impacted major retail store brands. The affected products included:
- CVS Health: Lubricant Eye Drops, Multi-Action Relief Drops, Lubricating Gel Drops
- Leader (Cardinal Health): Dry Eye Relief, Eye Irritation Relief
- Rite Aid: Gentle Lubricant Gel Eye Drops, Multi-Action Relief
- Target: Up&Up Dry Eye Relief, Up&Up Extreme Relief
- Walmart: Equate Hydration PF Lubricant Eye Drop
Early 2023: EzriCare & Delsam Pharma
In early 2023, the CDC and FDA issued a massive warning regarding EzriCare and Delsam Pharma Artificial Tears due to a severe outbreak of a rare, drug-resistant strain of Pseudomonas aeruginosa. Consumers were advised to immediately stop the use of these products manufactured by Global Pharma Healthcare Private Limited.
Frequently Asked Questions
What is the 2026 FDA eye drop recall?
In April 2026, a voluntary recall was initiated for millions of over-the-counter eye drops manufactured by K.C. Pharmaceuticals due to a lack of assurance of sterility.
Which eye drop brands are affected by the recall?
The recall includes popular store brands such as CVS Health, Walgreens, Kroger, Geri-Care, GoodSense, Leader, and Rugby Laboratories.
How do I check if my eye drops are recalled?
Find the lot number printed on the side of your bottle or the bottom of the box and compare the starting letters and numbers to the official FDA recall list.
What should I do if I have a recalled bottle?
Stop using the drops immediately, throw the bottle away or return it to the retailer, and contact an eye doctor if you experience any pain, redness, or vision changes.
What does a voluntary recall mean?
It means the manufacturer chose to pull the products from shelves on their own after discovering the sterility issue, rather than waiting for a government mandate.
Are there safe alternatives I can use?
Yes, products manufactured in unaffected supply chains, such as Reliable 1 Lubricating Tears, GenTeal, and Bausch & Lomb Advanced Eye Relief, are safe to use and currently in stock.
