CLASS II ONGOING Drug recall · Reported 30 Sep 2026 · FDA Enforcement Report
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalled
Sterling Pharmaceutical Services is recalling AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, distributed nationwide in the US. The recall was initiated on 20 Aug 2026 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0855-2026
- FDA event ID
- 99712
- Recalling firm
- Sterling Pharmaceutical Services, Dupo, IL
- Manufacturer
- AvPAK
- Classification
- Class II
- Status
- Ongoing
- Recall initiated
- 20 Aug 2026
- FDA classified
- 21 Sep 2026
- Reported
- 30 Sep 2026
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Eye Drops
Timeline
| 20 Aug 2026 | Recall initiated by company | |
| 21 Sep 2026 | Classified by FDA | +32 days |
| 30 Sep 2026 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
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
Where it was distributed
USA Nationwide
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility
Which lots are affected?
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
Where was it sold?
USA Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 6 Oct 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
8 other products · FDA event 99712This product is part of a recall event; the main page for the event is TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recalled.
More recalls from Sterling Pharmaceutical Services
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Major LubriFresh P.M. Nighttime Ointment recalled | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Reliable -1 Laboratories, Sodium Chloride Hypertonicity recalledSodium Chloride Hypertonicity Ophthalmic Solution, 5% | Sterling Pharmaceutical Services | Sterility | Nationwide |
Other Carboxymethylcellulose recalls
All 17| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Reliable-1 Laboratories Lubricating Tears, Sterile recalledLubricating Tears | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Lubricant Eye Drops recalled by Sterling PharmaceuticalWalgreens Lubricant Eye Drops | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | Walgreens Lubricant Eye Drops Total Twin Pack recalledWalgreens Lubricant Eye Drops | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | AvKare Carboxymethylcellulose Sodium Ophthalmic Solution recalledCarboxymethylcellulose Sodium | Sterling Pharmaceutical Services | Sterility | Nationwide |
| Drug | CLASS II | TRP The Relief Products* Gentle Eyes Lubricant Eye Drops recalledGentle Eyes Lubricant Eye Drops | Sterling Pharmaceutical Services | Sterility | Nationwide |