Fluocinolone Acetonide Solution (Novel Laboratories) – chemical contamination (2017)
Class III: A situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences
Class III recall indicates unlikely adverse health consequences.
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% For Topical Use Only, Not for Ophthalmic Use, 60 mL bottle, Rx Only, Manufactured for Gavis Pharmaceuticals, LLC, Somerset NJ 08873, Manufactured by Novel Laboratories, Inc. Somerset, NJ 08873, NDC 43386-069-60
Brand
Novel Laboratories, Inc.
Lot Codes / Batch Numbers
Lot # M15496, Exp. 10/17 Lot # M15507, Exp. 12/17
Products Sold
Lot # M15496; Exp. 10/17 Lot # M15507; Exp. 12/17
Novel Laboratories, Inc. is recalling Fluocinolone Acetonide Topical Solution USP 0.01% For Topical Use Only, Not for Ophthalmic Use, 60 due to Chemical Contamination. 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
Chemical Contamination
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