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FDA Recall Alerts For Eye Care Products You Should Know

Eye drops and ointments have to be sterile to be safe.

In the last few years, the U.S. Food and Drug Administration (FDA) has issued multiple recall alerts affecting popular eye care products—from artificial tears to prescription glaucoma drops. This guide summarizes notable recent recalls, why they happened, what to do if you have these products, safer alternatives to consider, and how to stay on top of new alerts.

Recent FDA eye care recalls: what was pulled and why

Below are some of the most widely reported U.S. recalls and warnings since 2023. Always verify the latest status and specific lot numbers using the FDA’s official recall search before making decisions or disposing of products. You can search by product name, brand, or National Drug Code (NDC) on the FDA’s recalls portal.

Most of these recalls involve sterility concerns—either confirmed microbial contamination or manufacturing conditions that didn’t meet sterile standards. That matters because non-sterile eye products can cause serious infections, vision loss, or, rarely, life-threatening illness.

If a product you use appears on any FDA alert, stop using it and follow the steps below.

This list isn’t exhaustive and doesn’t replace your eye doctor’s guidance. If you’re unsure whether your exact bottle or lot is affected, bring it to your pharmacist or ophthalmologist for confirmation.

  • EzriCare Artificial Tears (Global Pharma Healthcare) — Recalled in 2023 after a multi-state outbreak of a rare, drug-resistant Pseudomonas aeruginosa; infections led to severe outcomes, including vision loss. Reason: contamination risk and lack of sterility assurance. Safer alternative: preservative-free single-use lubricant tear vials from established manufacturers (e.g., Systane PF, Refresh Plus PF, Blink PF); discard each vial after one use.

  • Delsam Pharma’s Artificial Tears — Also recalled in 2023, manufactured by the same company as EzriCare, for sterility concerns. Safer alternative: preservative-free, single-use tears from major brands; avoid multi-dose preservative-free bottles unless they use proven antimicrobial technology.

  • Delsam Pharma’s Artificial Eye Ointment — Recalled for lack of sterility assurance. Eye ointments are especially risky if contaminated because they remain on the eye longer. Safer alternative: sterile night-time ointments from well-established manufacturers (e.g., Refresh Lacri-Lube, Systane Nighttime) purchased from reputable retailers.

  • “Purely Soothing” 15% MSM Drops (Pharmedica USA) — Voluntarily recalled in 2023 due to non-sterility concerns; MSM eye drops are not FDA-approved drugs. Safer alternative: stick to FDA-approved artificial tears and, for moderate-to-severe dry eye, talk to your eye doctor about prescription options like cyclosporine or lifitegrast.

  • Brimonidine tartrate ophthalmic solution 0.15% (Apotex) — Recalled lots in 2023 due to potential cracked bottle caps that could compromise sterility. Safer alternative: ask your pharmacist for an unaffected lot/manufacturer or discuss brand-name Alphagan P or another glaucoma medication per your prescriber’s guidance.

  • Multiple store-brand OTC eye drops (CVS, Rite Aid, Target, Leader, Rugby, others) — In late 2023, FDA warned consumers not to use certain OTC lubricating/eye-wash products from several retailers due to unsanitary manufacturing conditions; many were subsequently recalled or removed from sale. Safer alternative: choose products from unaffected manufacturers, or switch to single-use preservative-free vials until your pharmacist verifies safe supply.

  • Akorn ophthalmic products (multiple) — In 2023, Akorn Pharmaceuticals issued a wide, company-level recall after ceasing operations, which included many prescription and OTC eye products. Safer alternative: your pharmacist can substitute the same active ingredient from another manufacturer; confirm the new product’s lot is not affected by any alert.

To verify specific lot numbers and dates for any of the above, use the FDA’s Recall, Market Withdrawal, and Safety Alerts search. For outbreak summaries related to artificial tears, see CDC’s healthcare-associated infections updates.

FDA recalls and safety alerts (search) | FDA medical product safety hub | CDC HAI outbreaks

What to do if you have or used a recalled eye product

Step-by-step if the product is in your cabinet

  • Stop using it immediately. Check the exact brand, size, NDC/UPC, and lot/expiration on the label against the FDA recall page or your retailer’s notice.
  • Do not test it “one more time.” Even a single use of a contaminated product can cause infection.
  • Follow disposal guidance. Unless instructed otherwise in the recall notice, seal the bottle in a bag and place it in household trash; do not flush. When in doubt, follow FDA’s medicine disposal guidance or a local take-back program.
  • Request a refund or replacement. Retailers and manufacturers typically honor recalls; bring the product or receipt to the store or contact the manufacturer’s recall hotline.

Learn more: FDA disposal guidance | Recalls.gov (multi-agency)

If you used a recalled product and have symptoms

  • Seek care urgently for eye pain, redness, swelling, discharge, light sensitivity, fever, or any change in vision. Tell the clinician the exact product and lot you used.
  • Bring the bottle (if available) to your appointment; it may help clinicians and public health trace lot-specific problems.
  • Report to FDA MedWatch to help improve surveillance, especially if you experienced an adverse event or needed treatment.

Report problems: FDA MedWatch (report an adverse event)

Safer alternatives for each recalled category

Here are practical substitutions to ask your pharmacist or eye doctor about. Always confirm the exact product and lot are not on any current alert before purchase.

  • Artificial tears recalled for sterility (e.g., EzriCare, Delsam) → Consider preservative-free, single-use vials from established manufacturers (examples: Systane PF, Refresh Plus PF, Blink PF). These reduce contamination risk because each vial is discarded after use.
  • Recalled eye ointments (e.g., Delsam ointment) → Consider sterile, night-time ophthalmic ointments from major manufacturers (e.g., Refresh Lacri-Lube, Systane Nighttime). Use clean hands and avoid touching the tip to lashes/skin.
  • Non–FDA-approved MSM eye drops (e.g., Purely Soothing 15% MSM) → Avoid MSM for ocular use. Use FDA-approved artificial tears for lubrication; for chronic dry eye, ask about prescription therapies such as cyclosporine or lifitegrast, or non-drug options like warm compresses and lid hygiene.
  • Brimonidine 0.15% lots recalled (Apotex) → Pharmacist can dispense an unaffected generic lot or your prescriber may switch you to brand Alphagan P or to a different class (e.g., prostaglandin analogs like latanoprost) based on your clinical needs.
  • Store-brand OTC products flagged for unsanitary manufacturing → Until supply is verified, choose unaffected national brands or single-use vials. Buy from high-throughput pharmacies (better turnover) and confirm lot numbers with the pharmacist.
  • Company-wide recalls (e.g., Akorn) → Ask your pharmacist to substitute the same active ingredient from another reputable manufacturer and verify the replacement against the FDA recall database before you leave the counter.

How to minimize risk when buying and using eye drops

  • Check seals and dates. Use products with intact tamper-evident seals and unexpired dates; avoid any bottle with a cracked cap or damaged tip.
  • Prefer single-use vials if you’re immunocompromised or prone to infections.
  • One bottle, one person. Don’t share eye drops, even within a family.
  • Don’t touch the tip. If the tip touches your eye, lashes, or skin, consider the bottle contaminated.
  • Store correctly. Follow the label for temperature and discard-after-opening timelines.
  • Buy from reputable sources. Stick with licensed pharmacies or the manufacturer’s authorized retailers, not third-party marketplace sellers of uncertain origin.

Stay on top of new FDA recall alerts

  • Bookmark the FDA recall search and check it before buying unfamiliar brands or refilling after a long gap.
  • Sign up for FDA email alerts for timely updates on recalls and safety notices.
  • Ask your pharmacist to flag your profile if a product you use is affected.
  • Follow your ophthalmologist’s guidance for product selection tailored to your diagnosis (dry eye, allergy, glaucoma, etc.).

Get alerts: FDA recalls portal | Sign up for FDA email updates | AAO: Eye health information

FAQ: refunds, insurance, and documentation

  • Can I get my money back? Most retailers honor FDA recalls; bring the item or receipt. Manufacturer recall pages often list refund instructions.
  • Will insurance cover a safer alternative? For OTC products, you’ll usually pay out of pocket. For prescriptions, your prescriber can request a covered alternative or a prior authorization if needed.
  • How should I document an issue? Keep photos of the bottle, lot/expiration, purchase receipt, and your symptoms/treatment. Submit a MedWatch report if you had an adverse event.
  • Who can help me choose safely? Your ophthalmologist and pharmacist are the best resources for product selection and verification. You can also use the FDA safety hub to review current advisories.

If you’ve been affected by a recalled eye product, you’re not alone. The key is to stop use, verify details on the FDA site, seek care promptly for any symptoms, and switch to a vetted, sterile alternative with help from your eye care team.