FDA Drug recall D-0863-2026
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
- 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) EACH, 1.0 FL OZ (30 mL) TOTA… by Sterling Pharmaceutical Services, citing lack of Assurance of Sterility.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0863-2026 |
| 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) EACH, 1.0 FL OZ (30 mL) TOTAL, 2 count Twin Pack, Distributed by: AVKARE, Pulaski, TN, 38478, NDC 50268-068-02 (carton)
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
- TRP The Relief Products* Gentle Eyes Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Sterile Eye Drops, 0.5 FL OZ (15 mL) bottles,…
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 - 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 - Walgreens Lubricant Eye Drops, Carboxymethylcellulose sodium 0.5%, Lubricant Eye Drops, Sterile, 0.5 OZ (15 mL) bottles, Distributed by Wal…
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-0863-2026%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.