Menu
Shedding Light on the Risks
& Benefits of Medications
Shedding Light on the Risks
& Benefits of Medications FDA Recalls and Warnings: Millions of Eye Drops Recalled, Including Clear Eyes and Walgreens Brands
Photo: Created with AI
Get the latest FDA updates on medication recalls, manufacturing violations, and quality concerns that could affect your prescriptions
September 25, 2026
0 Comments
republishPhoto: Created with AI
on this page:
Welcome to the FDA Recalls and Warnings Update, a series dedicated to keeping you informed about the latest medication recalls, manufacturing violations, and quality concerns affecting your prescriptions.
In this installment, we’re covering recalls for AvKare Carboxymethylcellulose Sodium Ophthalmic Solution Lubricant Eye Drops, Cameron Pharmaceuticals Carboxymethylcellulose Sodium Eye Drops, Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops, Reliable-1 Laboratories Lubricating Tears, Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution, Major Lubrifresh Nighttime Ointment, TRP The Relief Products Gentle Eyes Lubricant Eye Drops, and Walgreens Lubricant Eye Drops.
All of the recalls except for the Clear Eyes Redness Relief were initiated by Sterling Pharmaceutical Services, a contract pharmaceutical manufacturer that makes custom pharmaceutical products. All of the recalls in this installment have been assigned a “Class II” level by the FDA.
These are nationwide retail and supplier-level recalls and are not directed at consumers. However, consumers may wish to check the linked enforcement report for the list of affected product lot numbers and expiration dates.
How To Read This Report
The Food and Drug Administration (FDA) categorizes product recalls in its Enforcement Report database based on the level of health risk, labeling them as Class I, II, III, or “not yet classified.”
While the database includes drugs, food, cosmetics, medical devices, biologics, tobacco, and veterinary products, this report only covers selected drug recalls.
- Class I recalls are the most serious. In these situations, there is “reasonable probability that the use of or exposure to a product will cause serious adverse health consequences or death.”
- Class II recalls are for drugs that may cause temporary or medically reversible adverse health consequences or where use of the product is unlikely to result in serious adverse health consequences.
- Class III recalls are the least serious. Use of the product is not likely to cause adverse health consequences.
Drug manufacturers, supplement companies, and medical device makers may receive a Warning Letter from the FDA if they commit serious violations of federal regulations. This letter comes from an overseeing FDA office, such as the Center for Drug Evaluation and Research. Common violations include poor manufacturing practices, false product claims, selling misbranded items, or marketing unapproved products. The letter gives the recipient a chance to correct the issues and requires a response, usually within 15 days.
FDA Import Alerts notify field staff and the public when the agency has enough evidence to detain products without physical examination (DWPE) due to suspected violations of FDA laws, including violations of “current good manufacturing practices for finished pharmaceuticals” or unapproved new drugs. The violations lists are arranged by type of violation, then by country and then by the importing company. In some cases, Import Alerts may be linked to Warning Letters for issues like manufacturing violations.
Drug Recalls
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops
Company: Sterling Pharmaceutical Services LLC, Dupo, Illinois
Manufacturing Location: Not specified, but Sterling Pharmaceutical manufacturing facility is in Dupo, Illinois; distributed by AvKare, Pulaski, Tennessee
Scope: 12,864 twin packs of 0.5 fl oz (15 mL) bottles from one lot that expired in August 2026; 107,377 twin packs of 0.5 fl oz (15 mL) bottles from nine additional lots that expire in 2027.
Drug Purpose: Over-the-counter eye lubricant used for temporary relief of burning, irritation, and discomfort caused by dry eyes or exposure to wind or sun.
Recall Reason: Lack of assurance of product sterility; the products may not have been manufactured under proper sterile conditions
Recall Initiation Date: August 20, 2026
Recall Level: Class II
Essential Extras: AvKare issued a notice to its customers that this recall was requested by the FDA after a recent inspection of the Sterling manufacturing facility. Sterling Pharmaceutical’s eye drops manufacturing facility in Dupo, Illinois, received an FDA Warning Letter in September 2022 after an inspection found sterility and quality problems. Sterling also issued a recall on August 20, 2026, for 57,848 packs of Puralube Vet Ointment, a non-prescription petroleum eye ointment for dogs and cats.
Link: FDA Enforcement Report
Cameron Pharmaceuticals Carboxymethylcellulose Sodium 0.5%,
Company: Sterling Pharmaceutical Services LLC, Dupo, Illinois
Manufacturing Location: Not specified, but Sterling Pharmaceutical manufacturing facility is in Dupo, Illinois; distributed by Cameron Pharmaceuticals LLC, Louisville, Kentucky
Scope: 19,284 units of 0.5 fl oz (15 mL) bottles
Drug Purpose: Over-the-counter lubricant eye drops intended for temporary relief of dry-eye burning, irritation, and discomfort, and for protection against further irritation.
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: August 20, 2026
Recall Level: Class II
Essential Extras: Another company affected by the Sterling recall, AvKare, issued a notice to its customers that the recall was requested by the FDA after a recent inspection of the Sterling manufacturing facility. Sterling Pharmaceutical’s eye drops manufacturing facility in Dupo, Illinois, received an FDA Warning Letter in September 2022 after an inspection found sterility and quality problems. Sterling also issued a recall on August 20, 2026, for 57,848 packs of Puralube Vet Ointment, a non-prescription petroleum eye ointment for dogs and cats.
Link: FDA Enforcement Report
Clear Eyes Redness Relief, Lubricant/Redness Reliever Eye Drops (glycerin 0.25%, naphazoline hydrochloride 0.012%)
Company: Insight Pharmaceuticals LLC, a Prestige Consumer Healthcare Company, Tarrytown, New York
Manufacturing Location: Canada; distributed nationwide by Medtech Products Inc., Tarrytown, New York
Scope: 2,356,248 bottles containing .5 fluid ounce (15 mL); unspecified quantity of .5 fluid ounce (15 mL) bottles with Hang Tag packaging; distributed nationwide in the United States.
Drug Purpose: Over-the-counter eye drops intended for temporary relief of eye redness, burning, and irritation.
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: September 15, 2026
Recall Level: Class II
Essential Extras: The FDA enforcement report does not identify this product’s manufacturing location, but the drug label specifies Canada as the manufacturing location. In July, more than 39,000 bottles of Prestige Brands’ CLEAR EYES Maximum Itchy Eye Relief were recalled due to sterility concerns and potential contamination.
Link: FDA Enforcement Report
Reliable-1 Laboratories Lubricating Tears
Company: Sterling Pharmaceutical Services LLC, Dupo, Illinois
Manufacturing Location: Not specified, but Sterling Pharmaceutical Services’ manufacturing facility is in Dupo, Illinois; distributed by Reliable-1 Laboratories LLC, Valley Stream, New York
Scope: 47,616 units of 0.5 fl oz (15 mL) eye drops
Drug Purpose: Lubricant eye drops intended for temporary relief of dry-eye burning, irritation, and discomfort, and for protection against further irritation.
Recall Reason: Lack of assurance of product sterility
Recall Initiation Date: August 20, 2026
Recall Level: Class II
Essential Extras: Another company affected by the Sterling recall, AvKare, issued a notice to its customers that the recall was requested by the FDA after a recent inspection of the Sterling manufacturing facility. Sterling Pharmaceutical’s eye drops manufacturing facility in Dupo, Illinois, received an FDA Warning Letter in September 2022 after an inspection found sterility and quality problems. Sterling also issued a recall on August 20, 2026, for 57,848 packs of Puralube Vet Ointment, a non-prescription petroleum eye ointment for dogs and cats.
Link: FDA Enforcement Report
Reliable-1 Laboratories Sodium Chloride Hypertonicity Ophthalmic Solution, 5%
Company: Sterling Pharmaceutical Services LLC, Dupo, Illinois
Manufacturing Location: Not specified, but Sterling Pharmaceutical manufacturing facility is in Dupo, Illinois; distributed by Reliable-1 Laboratories LLC, Valley Stream, New York
Scope: 11,083 units of 5% sodium chloride 0.5 fl oz (15 mL) bottles
Drug Purpose: Over-the-counter hypertonicity eye drops used for temporary relief of corneal edema, or swelling of the cornea.
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: August 20, 2026
Recall Level: Class II
Essential Extras: Another company affected by the Sterling recall, AvKare, issued a notice to its customers that the recall was requested by the FDA after a recent inspection of the Sterling manufacturing facility. Sterling Pharmaceutical’s eye drops manufacturing facility in Dupo, Illinois, received an FDA Warning Letter in September 2022 after an inspection found sterility and quality problems. Sterling also issued a recall on August 20, 2026, for 57,848 packs of Puralube Vet Ointment, a non-prescription petroleum eye ointment for dogs and cats.
Link: FDA Enforcement Report
Major LubriFresh P.M. Nighttime Ointment (Light Mineral Oil 15% White Petrolatum 83%)
Company: Sterling Pharmaceutical Services LLC, Dupo, Illinois
Manufacturing Location: Not specified, but the Sterling Pharmaceutical manufacturing facility is in Dupo, Illinois; distributed by Major Pharmaceuticals, Livonia, Michigan
Scope: 34,368 units of 0.125 oz. (3.5 g) bottles
Drug Purpose: Over-the-counter lubricating eye ointment for temporary relief of burning, irritation, and discomfort from eye dryness or exposure to wind or sun.
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: August 20, 2026
Recall Level: Class II
Essential Extras: Another company affected by the Sterling recall, AvKare, issued a notice to its customers that the recall was requested by the FDA after a recent inspection of the Sterling manufacturing facility. Sterling Pharmaceutical’s eye drops manufacturing facility in Dupo, Illinois, received an FDA Warning Letter in September 2022 after an inspection found sterility and quality problems. Sterling also issued a recall on August 20, 2026, for 57,848 packs of Puralube Vet Ointment, a non-prescription petroleum eye ointment for dogs and cats.
Link: FDA Enforcement Report
TRP The Relief Products Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%,
Company: Sterling Pharmaceutical Services LLC, Dupo, Illinois
Manufacturing Location: Not specified, but the Sterling Pharmaceutical manufacturing facility is in Dupo, Illinois; Manufactured exclusively for TRP Company Inc., Reno, Nevada
Scope: 14,538 units of 0.5 fl oz (15 mL) bottles
Drug Purpose: Over-the-counter lubricant eye drops intended for temporary relief of dry-eye burning, irritation, and discomfort, and for protection against further irritation.
Recall Reason: Lack of assurance of sterility.
Recall Initiation Date: August 20, 2026
Recall Level: Class II
Essential Extras: Another company affected by the Sterling recall, AvKare, issued a notice to its customers that the recall was requested by the FDA after a recent inspection of the Sterling manufacturing facility. Sterling Pharmaceutical’s eye drops manufacturing facility in Dupo, Illinois, received an FDA Warning Letter in September 2022 after an inspection found sterility and quality problems. Sterling also issued a recall on August 20, 2026, for 57,848 packs of Puralube Vet Ointment, a non-prescription petroleum eye ointment for dogs and cats.
Link: FDA Enforcement Report
Walgreens Lubricant Eye Drops, Carboxymethylcellulose Sodium 0.5%
Company: Sterling Pharmaceutical Services LLC, Dupo, Illinois
Manufacturing Location: Not specified, but the Sterling Pharmaceutical manufacturing facility is in Dupo, Illinois; distributed by Walgreen Co., Deerfield, Illinois
Scope: 301,114 units of 0.5 oz (15 mL) bottles and 199,600 twin packs of 0.5 fl oz (15 mL) bottles
Drug Purpose: Lubricant eye drops intended for temporary relief of dry-eye burning, irritation, and discomfort, and for protection against further irritation.
Recall Reason: Lack of assurance of sterility
Recall Initiation Date: August 20, 2026
Recall Level: Class II
Essential Extras: Another company affected by the Sterling recall, AvKare, issued a notice that the recall was requested by the FDA after a recent inspection of the Sterling manufacturing facility. Sterling Pharmaceutical’s eye drops manufacturing facility in Dupo, Illinois, received an FDA Warning Letter in September 2022 after an inspection found sterility and quality problems. Sterling also issued a recall on August 20, 2026, for 57,848 packs of Puralube Vet Ointment, a non-prescription petroleum eye ointment for dogs and cats.
Link: FDA Enforcement Report
DISCLAIMER: MedShadow provides information and resources related to medications, their effects, and potential side effects. However, it is important to note that we are not a substitute for professional medical advice, diagnosis, or treatment. The content on our site is intended for educational and informational purposes only. Individuals dealing with medical conditions or symptoms should seek guidance from a licensed healthcare professional, such as a physician or pharmacist, who can provide personalized medical advice tailored to their specific circumstances.
While we strive to ensure the accuracy and reliability of the information presented on MedShadow, we cannot guarantee its completeness or suitability for any particular individual’s medical needs. Therefore, we strongly encourage users to consult with qualified healthcare professionals regarding any health-related concerns or decisions. By accessing and using MedShadow, you acknowledge and agree that the information provided on the site is not a substitute for professional medical advice and that you should always consult with a qualified healthcare provider for any medical concerns.
on this page:
RECOMMENDED:
December 14, 2021
Tyrvaya … A Nasal Spray for Dry Eyes?
DONATE:
Help fund our fight for improved medication safety and transparency by supporting our independent journalism.
Give NowWe seek to create a world where there are safer medications for all and where all people are fully informed about their medication benefits and side effects, using our explanatory and investigative journalism to both inform and stimulate public discussion to drive toward solutions.
WEBINARS
Stream our library on demand, including insights on generic drugs and pain management, straight from experts.
WATCH NOW