FDA Drug recall D-0855-2026
AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKA…
- FDA Drug
- Class II
- ongoing
- Published 2026-09-30
On 2026-09-30 the FDA classified a Class II recall of AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) bottle, Distributed by: AVKA… by Sterling Pharmaceutical Services, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0855-2026 |
| Classification | Class II |
| Status | ongoing |
| Initiated | 2026-08-20 |
| Published | 2026-09-30 |
| Last updated | 2026-10-06 05:30 UTC |
| Company | Sterling Pharmaceutical Services |
| Distribution | US |
Product
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
Reason
Lack of Assurance of Sterility
Identifiers
| ndc | 50268-068-15 |
|---|---|
| ndc | 50268-068-02 |
| code_info | Lot# 3161, Exp 8/2026, Lot# 3245, Expiry: 3/2027; Lot# 3260, Expiry: 5/2027; Lot# 3298, Lot# 3299, and Lot# 3300, Expir…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 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-10-06 05:30 UTC. Current status: ongoing.
Other recalls by Sterling Pharmaceutical Services
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FDA Drug · Class II · 2026-09-30 · Sterling Pharmaceutical Services - Major LubriFresh P.M. Nighttime Ointment, Net wt. 0.125 oz. (3.5 g) tubes, Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Drive…
FDA Drug · Class II · 2026-09-30 · Sterling Pharmaceutical Services - Lubricant Eye Drops-Cameron Pharmaceuticals, Carboxymethylcellulose Sodium 0.5%, Eye Lubricant, 0.5 FL OZ (15 mL) bottles, Distributed by C…
FDA Drug · Class II · 2026-09-30 · Sterling Pharmaceutical Services - AvKare Carboxymethylcellulose Sodium Ophthalmic Solution 0.5%, Lubricant Eye Drops, Sterile, 0.5 FL OZ (15 mL) EACH, 1.0 FL OZ (30 mL) TOTA…
FDA Drug · Class II · 2026-09-30 · Sterling Pharmaceutical Services - Reliable -1 Laboratories, Sodium Chloride Hypertonicity Ophthalmic Solution, 5%, Sterile, 0.5 FL OZ (15 mL) bottles, Distributed by: Reliab…
FDA Drug · Class II · 2026-09-30 · Sterling Pharmaceutical Services
All Sterling Pharmaceutical Services recalls
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0855-2026%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.