Sterling Pharmaceutical Services recall: AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% and 6 more products
Sterling Pharmaceutical Services LLC is recalling AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% and 6 more products because of a sterility problem – 12,864 packs; 11083 bottles; 301114 bottles; 199600 packs; 47616 bottles; 14538 bottles; 34368 tubes; 19284 bottles; 107,377 packs. The U.S. Food and Drug Administration published the recall on September 30, 2026; it began on August 20, 2026. Distributed nationwide.
Serious Class II means the product may cause temporary or medically reversible health problems, or the chance of serious harm is remote.
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| Product | AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% and 6 more products |
| Brand | Sterling Pharmaceutical Services |
| Company | Sterling Pharmaceutical Services LLC |
| Type | Drugs |
| Classification | Class II |
| Recall date | August 20, 2026 |
| Published by FDA | September 30, 2026 |
| Quantity | 12,864 packs; 11083 bottles; 301114 bottles; 199600 packs; 47616 bottles; 14538 bottles; 34368 tubes; 19284 bottles; 107,377 packs |
| Recall ID | 99712 |
Recalled products (9)
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-15
- FDA recall number
- D-0855-2026
- Codes, lots and dates
- Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
- Quantity
- 12,864 packs
- Classification
- Class II
- Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, NDC 69618-077-55.
- FDA recall number
- D-0856-2026
- Codes, lots and dates
- Lot #3192, Exp Date 01/312027; 3293, 3336 Exp Date 06/30/2027
- Quantity
- 11083 bottles
- Classification
- Class II
- Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, NDC 0363-8833-15.
- FDA recall number
- D-0857-2026
- Codes, lots and dates
- Lot # 3166, Expiry: 9/2026; Lot # 3172, Expiry: 9/2026; Lot # 3173, Expiry: 9/2026; Lot # 3175, Expiry: 10/2026; Lot # 3176, Expiry: 10/2026; Lot # 3177, Expiry: 10/2026; Lot # 3178, Expiry:10/2026; Lot # 3180, Expiry: 11/2026; Lot # 3188, Expiry: 12/2026; Lot # 3202, Expiry: 12/2026; Lot # 3203, Expiry: 12/2026; Lot # 3205, Expiry: 12/2026; Lot # 3209, Expiry: 2/2027; Lot #3210, Expiry: 3/2027; Lot #3246, Expiry: 3/2027; Lot #3247, Expiry: 3/2027; Lot #3248, Expiry: 4/2027; Lot # 3249, Expiry: 4/2027; Lot # 3250, Expiry: 4/2027; Lot # 3252, Expiry: 4/2027; Lot # 3253, Expiry: 4/2027; Lot # 3261, Expiry: 5/2027; Lot # 3262, Expiry: 5/2027; Lot # 3263; Expiry 5/2027; Lot #3264, Expiry: 5/2027; Lot #3281, Expiry : 6/2027.
- Quantity
- 301114 bottles
- Classification
- Class II
- Walgreens Lubricant Eye Drops, 0.5 FL OZ (15 mL) 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by Walgreens Co., 200 Wilmot Road, Deerfield, IL 60015, NDC 0363-8833-15.
- FDA recall number
- D-0858-2026
- Codes, lots and dates
- Lot # 3165, Expiry: 9/2026; Lot # 3179, Expiry: 10/2026; Lot # 3204, Expiry: 12/2026; Lot #3206, Expiry: 12/2026, Lot # 3208, Expiry: 12/2026; Lot #3259, Expiry: 4/2027; Lot #: 3265, Expiry: 5/2027; Lot # 3268; Expiry 6/2027; Lot #3272, Expiry: 5/2027; Lot # 3273, Expiry: 6/2027; Lot #3276, Expiry: 6/2027; Lot # 3278, Expiry: 6/2027; Lot # 3280, Expiry: 6/2027; Lot # 3307, Expiry: 7/2027; Lot # 3309, Expiry: 7/2027; Lot # 3315, Expiry: 7/2027.
- Quantity
- 199600 packs
- Classification
- Class II
- Reliable-1 Laboratories Lubricating Tears, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliable-1 Laboratories LLC, Valley Stream, NY, 11580, www.reliable1labs.com, NDC 69618-076-55.
- FDA recall number
- D-0859-2026
- Codes, lots and dates
- Lot # 3171, Expiration Date 09/30/2026. Lot # 3174, Expiration Date 10/31/2026; Lot #3275, Expiration Date, 06/30/2027; Lot #3304, Expiration date 07/31/2027.
- Quantity
- 47616 bottles
- Classification
- Class II
- TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles, Manufactured exclusively for TRP Company, Inc. 1575 Delucci Ln, Reno, NV 89502, NDC 17312-430-15.
- FDA recall number
- D-0860-2026
- Codes, lots and dates
- Lot # 3279, Exp 6/30/2027; Lot # 3292, Exp 5/31/2027.
- Quantity
- 14538 bottles
- Classification
- Class II
- Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152, NDC 0904-6488-38
- FDA recall number
- D-0861-2026
- Codes, lots and dates
- Lot # 3183
- Quantity
- 34368 tubes
- Classification
- Class II
- Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by Cameron Pharmaceuticals, LLC, Louisville, KY, 40245, NDC 42494-448-05
- FDA recall number
- D-0862-2026
- Codes, lots and dates
- Lot # 3163, Expiry: 8/31/2026; Lot# 3164, Expiry: 9/30/2026.
- Quantity
- 19284 bottles
- Classification
- Class II
- AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)
- FDA recall number
- D-0863-2026
- Codes, lots and dates
- Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expiry: 6/2027; Lot# 3301, Lot# 3302, Lot# 3305 and Lot# 3306, Expiry: 7/2027
- Quantity
- 107,377 packs
- Classification
- Class II
Identifiers and details
- FDA event ID
- 99712
- Initiated
- Voluntary: Firm initiated
- Status
- Ongoing
- Firm location
- Dupo, IL, United States
Why it was recalled
The problem: a sterility problem.
The reason the FDA lists: “Lack of Assurance of Sterility”
Where it was sold
Nationwide. Distribution as the FDA records it: “USA Nationwide”
What to do
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Official notice: FDA Enforcement Report record (event 99712, openFDA) – the same recall numbers can be searched in the FDA Enforcement Report.
Other drug recalls
| Date | Recall | Problem | Agency |
|---|---|---|---|
| Oct 7, 2026 |  Ajanta Pharma recall: Ranolazine Extended-Release TabletsDrugs | Failed Dissolution Specifications: below specification Serious | FDA Class II |
| Oct 7, 2026 | Par Health recall: Buprenorphine HydrochlorideDrugs · 154210 bottles | Crystallization Serious | FDA Class II |
| Oct 7, 2026 | Apotex recall: Paroxetine Extended-Release TabletsDrugs | Failed dissolution specifications. Serious | FDA Class II |
| Oct 7, 2026 | TerSera Therapeutics recall: ZoladexDrugs · 296 cartons | Temperature Abuse: Product sat in a non-temperature-controlled FedEx trailer at ambient ou… Serious | FDA Class II |
| Oct 7, 2026 | Aurolab Trust recall: FOCUS PI Hypromellose 0.7% FormulaDrugs · 25,220 bottles | a sterility problem Serious | FDA Class II |
| Oct 7, 2026 | Amneal Pharmaceuticals recall: Estradiol GelDrugs · 2,592 30-count cartons | Defective Container; packets were found to be either empty or partially full. Serious | FDA Class II |
About this recall
Is Sterling Pharmaceutical Services AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5% recalled?
Yes. Sterling Pharmaceutical Services LLC recalled it on August 20, 2026; FDA published it September 30, 2026 (Class II). Only the lots, dates or models listed on this page are included.
Why was it recalled?
Because of a sterility problem. The reason given: Lack of Assurance of Sterility
What should I do if I have it?
Compare the recall numbers, lot numbers and expiration dates with what you have. Do not stop a prescribed medicine or device without talking to your pharmacist or doctor – they can arrange a replacement from an unaffected lot.
Where was it sold?
Nationwide.
More recalls
Source: recall records published by the U.S. Food and Drug Administration (openFDA Enforcement Reports), the USDA Food Safety and Inspection Service, the Consumer Product Safety Commission and the National Highway Traffic Safety Administration, collected twice a day. Product names, lot codes, dates and model numbers are shown exactly as the agency lists them; the agency's notice is the authority. 77.today is not affiliated with any of these agencies.