Polyvinyl Alcohol Ophthalmic Solution 1 — Class III drug recall D-0176-2025
Ongoing recall by AvKARE, reported 2025-01-08, distributed nationwide. LABELING: LABEL MIX-UP
| Recall number | D-0176-2025 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Ongoing |
| Voluntary or mandated | Voluntary |
| Recalling firm | AvKARE, Pulaski, TN, United States |
| Recall initiated | 2024-12-18 |
| Classified | 2025-01-02 |
| Reported by FDA | 2025-01-08 |
| Distributed | Nationwide (US) |
| Quantity | 0 |
| Reason classes | labeling |
| NDC | 50268-0678, 50268-0678-15 |
| Lot numbers | 0160 |
| Expiration dates | 2026-04-26 |
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 for recall
LABELING: LABEL MIX-UP
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-0176-2025. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.