Sterling Pharmaceutical Services Eye Drop Recall, Walgreens, AvKare and Other Brands, Lot Numbers and What to Do

On August 20, 2026, Sterling Pharmaceutical Services LLC of Dupo, Illinois began a nationwide recall of nine over-the-counter eye drop and ointment products because of a “lack of assurance of sterility,” meaning the manufacturer cannot guarantee the products are sterile. The FDA classified the recall as Class II in its enforcement report for the week of September 25, 2026.

The products were sold under the Walgreens, AvKare, Reliable-1 Laboratories, TRP Gentle Eyes, Cameron Pharmaceuticals and Major LubriFresh names. Sterling also recalled 57,848 packs of Puralube Vet Ointment, a veterinary eye ointment for dogs and cats, on the same day.

Based on the sources reviewed, no injuries or infections have been reported, and no class action or settlement exists. There is no claim form or claim deadline.

Quick Facts: Sterling Pharmaceutical Services Eye Drop Recall

Detail	Information
Manufacturer	Sterling Pharmaceutical Services LLC, Dupo, Illinois
Recall initiated	August 20, 2026
FDA classification	Class II (enforcement report week of September 25, 2026)
Reason	Lack of assurance of sterility
Products	9 listings: Walgreens (single and twin pack), AvKare (two listings), Reliable-1 (two), TRP Gentle Eyes, Cameron, Major LubriFresh P.M.
Distribution	Nationwide
FDA event ID	99712
Injuries or infections reported	None found in the sources reviewed
Class action / settlement / claim form	None

What Does a Class II Recall Mean for Sterling Pharmaceutical Eye Drops?

The FDA defines a Class II recall as one where exposure to the product “may cause temporary or medically reversible adverse health consequences” or where the probability of serious harm is remote. It is less serious than Class I, but it is not trivial. Eye products are meant to be sterile, and contact lens wearers, people who recently had eye surgery, people with weakened immune systems and frequent users of lubricant drops are the ones who should pay the closest attention.

MedShadow notes these are supplier- and retail-level recalls not directed at consumers, and The Healthy reports that Sterling has not published a public recall notice or consumer instructions.

Which Sterling Eye Drops Were Recalled? Units Recalled by Brand

Product	Distributor	Units Recalled
Walgreens Lubricant Eye Drops, carboxymethylcellulose sodium 0.5% (15 mL)	Walgreen Co., Deerfield, IL	301,114 bottles
Walgreens Lubricant Eye Drops Twin Pack	Walgreen Co.	199,600 twin packs
AvKare Lubricant Eye Drops Twin Pack (two listings)	AvKare, Pulaski, TN	12,864 + 107,377 twin packs
Reliable-1 Laboratories Lubricating Tears	Reliable-1 Laboratories, Valley Stream, NY	47,616 units
Reliable-1 Laboratories Sodium Chloride Hypertonicity Solution 5%	Reliable-1 Laboratories	11,083 units
Major LubriFresh P.M. Nighttime Ointment (3.5 g)	Major Pharmaceuticals, Livonia, MI	34,368 units
Cameron Pharmaceuticals Lubricant Eye Drops	Cameron Pharmaceuticals, Louisville, KY	19,284 units
TRP The Relief Products Gentle Eyes Lubricant Eye Drops	TRP Company Inc., Reno, NV	14,538 units
Puralube Vet Ointment (veterinary, separate recall)	n/a	57,848 packs

Adding the eight human-use rows (counting each twin pack as one unit) gives 747,844 units, a figure calculated here from the published unit counts.

Sterling Eye Drop Recall Lot Numbers to Check

Check the bottle or carton for the brand, lot number and expiration date. These lots were published from the FDA’s enforcement report.

Brand / Product	Lots and Expiration
Walgreens Lubricant Eye Drops (15 mL)	3166, 3172, 3173 (9/2026); 3175, 3176, 3177, 3178 (10/2026); 3180 (11/2026); 3188, 3202, 3203, 3205 (12/2026); 3209 (2/2027); 3210, 3246, 3247 (3/2027); 3248, 3249, 3250, 3252, 3253 (4/2027); 3261, 3262, 3263, 3264 (5/2027); 3281 (6/2027)
Walgreens Lubricant Eye Drops Twin Pack	3165 (9/2026); 3179 (10/2026); 3204, 3206, 3208 (12/2026); 3259 (4/2027); 3265, 3272 (5/2027); 3268, 3273, 3276, 3278, 3280 (6/2027); 3307, 3309, 3315 (7/2027)
AvKare Lubricant Drops Twin Pack	3161 (8/31/2026); 3245 (3/2027); 3260 (5/2027); 3298, 3299, 3300 (6/2027); 3301, 3302, 3305, 3306 (7/2027)
Reliable-1 Sodium Chloride Hypertonicity 5%	3192 (1/31/2027); 3293, 3336 (6/30/2027)
Reliable-1 Lubricating Tears	3171 (9/30/2026); 3174 (10/31/2026); 3275 (6/30/2027); 3304 (7/31/2027)
TRP Gentle Eyes Lubricant Eye Drops	3279 (6/30/2027); 3292 (5/31/2027)
Major LubriFresh P.M. Nighttime Ointment	3183 (no expiration listed)
Cameron Pharmaceuticals Lubricant Eye Drops	3163 (8/31/2026); 3164 (9/30/2026)

Because lot lists can be updated, confirm yours against the FDA Enforcement Report for event ID 99712.

Why the FDA and AvKare Say Sterling Pharmaceutical Eye Drops Were Recalled

AvKare told its customers that the recall was requested by the FDA after a recent inspection of Sterling’s Dupo manufacturing facility. The recall reason is lack of assurance of sterility, which means the products may not have been made under proper sterile conditions. The reports reviewed do not say that any bottle tested positive for contamination.

Sterling Pharmaceutical Services’ 2022 FDA Warning Letter

The FDA inspected Sterling’s Dupo facility (109 S 2nd Street) from February 7 to 18, 2022 and issued Warning Letter 629019 on September 27, 2022. The letter describes Sterling as a contract manufacturer of sterile OTC and homeopathic ophthalmic drug products using aseptic processing, and says investigators saw instances in producing two lots of sterile eye drops where the firm failed to ensure adequate monitoring of non-viable particulates. The 2022 letter and the 2026 recall are separate events, and the sources reviewed do not say the 2026 recall resulted from the same findings.

What Should You Do If You Have a Recalled Sterling Eye Drop?

• Check the brand, lot number and expiration date against the table above.
• If your product matches, the cautious step is to stop using it and ask the pharmacy where you bought it, such as Walgreens, about a return or refund. The Healthy advises contacting the retailer.
• Do not throw away the bottle if you have symptoms. Keep it and its packaging.
• See an eye doctor promptly for redness, pain, discharge, light sensitivity or blurred vision, especially if you wear contact lenses.
• Report a problem to the FDA’s MedWatch program.

This is general information, not medical advice. Ask a pharmacist or doctor about your own situation.

Can You File a Claim or Lawsuit Over the Sterling Eye Drop Recall?

There is no class action, settlement fund or claim form, and the sources reviewed report no injuries tied to these products. The recall is a regulatory action, so there is nothing to submit by a deadline.

If a person did suffer an eye infection or other injury after using a recalled lot, they might have an individual product liability claim. Whether that works depends on the facts, and personal injury filing deadlines vary by state (Illinois generally allows two years for personal injury claims, but check your own state). Talk to a licensed attorney. Be careful with websites that collect your information to promise a payout, since no official claims program exists.

Is This the Same as the Other 2026 Eye Drop Recalls?

No. 2026 has had several unrelated eye drop recalls: for example, a Clear Eyes Redness Relief recall by Insight Pharmaceuticals (initiated September 15, 2026, 2,356,248 bottles, Class II) and an earlier recall by another manufacturer. The Sterling recall covers only the nine products and lots listed above.

Sterling Eye Drop Recall Timeline

Date	Event
Feb. 7-18, 2022	FDA inspects Sterling’s Dupo, Illinois facility
Sept. 27, 2022	FDA issues Warning Letter 629019 to Sterling
Aug. 20, 2026	Sterling initiates the recall of nine products and the Puralube Vet recall
Week of Sept. 25, 2026	FDA classifies the recall as Class II
Oct. 2, 2026	No injuries, class action or claim process found in sources reviewed

FAQs: Sterling Pharmaceutical Services Eye Drop Recall

Which eye drops are recalled?

Nine products made by Sterling Pharmaceutical Services: Walgreens Lubricant Eye Drops (single and twin pack), AvKare Lubricant Drops Twin Pack, Reliable-1 Lubricating Tears and Sodium Chloride 5%, TRP Gentle Eyes, Cameron Pharmaceuticals and Major LubriFresh P.M. Nighttime Ointment.

Why were they recalled?

A lack of assurance of sterility.

What is the FDA recall class?

Class II.

When did the recall start?

August 20, 2026.

How many Walgreens eye drops were recalled?

301,114 bottles and 199,600 twin packs.

Is there a Sterling eye drop class action or settlement?

No class action or settlement was found, and there is no claim form or deadline.

Have any infections been reported?

None were found in the sources reviewed.

Does the recall include pet eye ointment?

Sterling separately recalled 57,848 packs of Puralube Vet Ointment on August 20, 2026.

Where is Sterling Pharmaceutical Services located?

Dupo, Illinois.

Where do I find the full FDA lot list?

In the FDA Enforcement Report under event ID 99712.

Sources for the Sterling Pharmaceutical Eye Drop Recall

1. FDA Enforcement Report, Sterling Pharmaceutical Services recall, event ID 99712 (as summarized by the outlets below).
2. MedShadow Foundation, “FDA Recalls and Warnings: Millions of Eye Drops Recalled, Including Clear Eyes and Walgreens Brands,” September 25, 2026.
3. The Healthy, “Another Eye Drop Recall Issued Nationwide Over Sterility Concerns,” September 25, 2026.
4. FDA Warning Letter 629019 to Sterling Pharmaceutical Services, LLC, September 27, 2022.
5. AvKare customer recall notice for carboxymethylcellulose sodium eye drops.

This article is for informational purposes only and is not medical or legal advice. Recall details, including lot lists, can change.

Researched and written by Israr Ahmad, legal content researcher and founder of AllAboutLawyer.com. All facts verified against the FDA’s September 27, 2022 Warning Letter to Sterling Pharmaceutical Services and published reports of the FDA Enforcement Report (event ID 99712) from MedShadow and The Healthy, as of October 2, 2026. Last Updated: October 2, 2026.