FDA Drug recall D-0176-2025
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN…
- FDA Drug
- Class III
- ongoing
- Published 2025-01-08
On 2025-01-08 the FDA classified a Class III recall of Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN… by Avkare, citing LABELING: LABEL MIX-UP.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0176-2025 |
| Classification | Class III |
| Status | ongoing |
| Initiated | 2024-12-18 |
| Published | 2025-01-08 |
| Last updated | 2026-09-13 11:52 UTC |
| Company | Avkare |
| Distribution | US |
Product
Polyvinyl Alcohol Ophthalmic Solution 1.4%, Moisturizing Lubricant Eye Drops, 0.5 FL OZ (15 mL) bottles, Distributed by AvKARE, Pulaski, TN 38478, www.avkare.com, NDC 50268-678-15
Reason
LABELING: LABEL MIX-UP
Identifiers
| ndc | 50268-678-15 |
|---|---|
| code_info | Lot #: 0160, Exp. Date April 26 2026 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: ongoing.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0176-2025%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.