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In 2025, BRS Analytical Service, LLC voluntarily recalled five ophthalmic products distributed by AvKare, LLC. The recall covered more than 75,000 cases shipped across the United States between May 26, 2023, and April 21, 2025. If you have one of these products, compare its name and NDC with the list below, then check the lot number against AvKare’s current notice. The stated concern was a lack of assurance of sterility—not confirmation that every bottle was contaminated.
Which eye-care products were recalled?
The five products are specific AvKare-distributed items, not every artificial tear or eye drop brand. Start by matching the product name and National Drug Code (NDC) on the package; then verify the lot number using AvKare’s Product Recalls & Safety Notices page and its linked notice.
| Product | NDC | Reported affected lots and expiry dates | Reported cases |
|---|---|---|---|
| Artificial Tears Ophthalmic Solution | 50268-043-15 | Lot 126, expires October 26, 2025; lot 127, expires October 30, 2025 | 13,872 |
| Carboxymethylcellulose Sodium Ophthalmic Gel 1% | 50268-066-15 | Lot 114, expires September 4, 2025; lot 115, expires September 6, 2025; lot 116, expires September 10, 2025; lot 207, expires December 5, 2026 | 1,610 |
| Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% | 50268-068-15 | Lot 103, expires April 26, 2025; lot 104, expires May 3, 2025 | 32,876 |
| Lubricant Eye Drops Solution | 50268-126-15 | Lot 117, expires September 20, 2025; lot 118, expires September 25, 2025 | 13,104 |
| Polyvinyl Alcohol Ophthalmic Solution 1.4% | 50268-678-15 | Lot 120, expires October 2, 2025; lot 122, expires October 9, 2025 | 14,333 |
Product names, NDCs, lots, expiry dates, and product-level case counts were reported by Forbes on May 14, 2025. The five counts total 75,795 cases; Forbes reports 24 cartons per case, so these figures are cases, not individual bottles. The lot and expiry details are historical information; use AvKare’s current notice to confirm whether a package is included.
Why were they recalled, and what does the risk statement mean?
Contemporaneous coverage said an FDA audit identified deviations from current Good Manufacturing Practice (cGMP). The FDA enforcement wording reported in that coverage described a “lack of assurance of sterility.” That is a concern about whether sterility was assured during manufacturing; it does not establish that every unit was contaminated.
#1 Best Overall
- ORIGINAL STRENGTH: Provides temporary relief for mild, occasional dry eye symptoms
- FAST ACTING: Instantly lubricates and moisturizes
- EASY TO USE: Apply 1-2 drops in the affected eye(s) as needed
- SOOTHING: Safe to use as often as needed
- VALUE SIZE: Two convenient multidose bottles
AvKare’s notice was quoted as stating: “Health Hazard to the user is unknown, cGMP deviations may lead to products of unacceptable quality, and it is not possible to rule out patient risks resulting from use of these products.” No confirmed injuries tied to this recall were identified in the reviewed coverage.
The FDA classified the five recalls as Class II on May 6, 2025. Fast Company describes that classification as a situation where exposure may cause reversible adverse health consequences, or where the probability of serious health consequences is remote. A class designation is not a personal assessment of an individual’s risk and does not mean every user was harmed.
Rank #2
- Immediate dry eye relief: TheraTears Lubricating Eye Drops provide immediate, long-lasting relief from dry eye symptoms such as burning, grittiness, and irritation
- Instant hydration: TheraTears Dry Eye Therapy eye drops restore eyes’ natural balance and deliver fast hydration relief for dry eyes; relieving irritated and itchy eyes
- Unique Formula: TheraTears eye drops formula contains OxyLytes, the 5 vital electrolytes found in natural tears
- Created by an ophthalmologist: The hydrating TheraTears formula was created by an ophthalmologist, following 18 years of research, for a one-of-a-kind eye drop
- Doctor-recommended: TheraTears is a doctor-recommended* brand, created to bring balance and hydration to dry eyes; your purchase may be FSA/HSA eligible, check your health plan for details; *ProVoice Survey data collected 9/1/23-8/31/24
What should you do if you have one?
- Check the package. Match its product name and NDC to the table, then compare the exact lot number with AvKare’s current recall notice. Do not rely on the product name alone.
- Stop using a listed affected lot. AvKare’s recall page instructs customers to immediately discontinue use of affected lots.
- Follow AvKare’s return process. The distributor says customers should examine inventory and submit its recall response form. It says customers will receive a return authorization and full credit, including shipping cost, for returns. Use the current notice and form for the precise steps.
- Ask about ongoing care if needed. If you rely on the product for treatment, ask a pharmacist or clinician what is appropriate for you. The recall materials do not specify a replacement product.
Where were the products sold, and when?
The products were distributed nationwide in the United States. AvKare recall reporting says shipments occurred from May 26, 2023, through April 21, 2025. That is the shipment window, not the date the FDA classified the recalls: the FDA classification was issued on May 6, 2025. The notices concern these five products and do not amount to a recall of all artificial tears or eye-care products.
Quick Recap
Best Value
- Immediate dry eye relief: TheraTears Lubricating Eye Drops provide immediate, long-lasting relief from dry eye symptoms such as burning, grittiness, and irritation
- Instant hydration: TheraTears Dry Eye Therapy eye drops restore eyes’ natural balance and deliver fast hydration relief for dry eyes; relieving irritated and itchy eyes
- Unique Formula: TheraTears eye drops formula contains OxyLytes, the 5 vital electrolytes found in natural tears
- Created by an ophthalmologist: The hydrating TheraTears formula was created by an ophthalmologist, following 18 years of research, for a one-of-a-kind eye drop
- Doctor-recommended: TheraTears is a doctor-recommended* brand, created to bring balance and hydration to dry eyes; your purchase may be FSA/HSA eligible, check your health plan for details; *ProVoice Survey data collected 9/1/23-8/31/24
Rank #4
- ORIGINAL STRENGTH: Provides temporary relief for mild, occasional dry eye symptoms
- FAST ACTING: Instantly lubricates and moisturizes
- PRESERVATIVE-FREE: Made with zero preservatives to relieve mild symptoms of dry eyes including irritation, and discomfort
- SOOTHING: Great for dry, sensitive eyes
- SOFT-SQUEEZE MULTIDOSE BOTTLE: Features a double lockout system that keeps drops sterile
Rank #3
- LASTING RELIEF: Original strength lubricating formula soothes mild symptoms of eye dryness
- PRESERVATIVE-FREE: Made with zero preservatives to relieve mild symptoms of dry eyes including burning, irritation, and discomfort
- FAST ACTING: Instantly moisturizes and lubricates
- RELIABLE PROTECTION: Active ingredients provide lasting lubrication for dry eyes
- GENTLE: Safe to use as often as needed. Great for dry, sensitive eyes
Product prices and availability are accurate as of the date/time indicated and are subject to change. Any price and availability information displayed on Amazon at the time of purchase will apply.
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