Povidone Iodine Ophthalmic Solution (Avella) – Sterility Risk (2019)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharmacy, 24416 N. 19th Ave., Phoenix, AZ 85085. NDC 42852-006-20
Brand
Avella of Deer Valley, Inc. Store 38
Lot Codes / Batch Numbers
Lot #: 138-20190205@3, Exp . Date 10/29/2019, 138-20190705@7, Exp. Date 11/3/2019
Products Sold
Lot #: 138-20190205@3, Exp . Date 10/29/2019; 138-20190705@7, Exp. Date 11/3/2019
Avella of Deer Valley, Inc. Store 38 is recalling Povidone Iodine, 5% Ophthalmic Solution, 5 mL per droptainer, Repackaged by: Avella Specialty Pharm due to Lack of sterility assurance.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
Lack of sterility assurance.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026