Fluocinolone Acetonide Solution (Teva) – Impurity Issues (2018)
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
Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavis Laboratories UT, Inc., Salt Lake City, UT 84108 USA; Distributed by: Actavis Pharmac, Inc., Parsippany, NJ 07054 USA, NDC 0591-2990-60.
Brand
Teva Pharmaceuticals USA
Lot Codes / Batch Numbers
Lot #s: 1164898, EXP 10/18, 1164904, 1164909, EXP 11/18, 1211396, EXP 07/19, 1230808, 1231127, EXP 01/20
Products Sold
Lot #s: 1164898, EXP 10/18; 1164904, 1164909, EXP 11/18; 1211396, EXP 07/19; 1230808, 1231127, EXP 01/20
Teva Pharmaceuticals USA is recalling Fluocinolone Acetonide Topical Solution, USP, 0.01%, 60 mL bottle, Rx Only, Manufactured by: Actavi due to Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification f. 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
Failed Impurities and Degradation Specifications and Subpotent Drug: out-of-specification (OOS) test results for below assay and above specification for degradants.
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