Nystatin Triamcinolone Cream (Dr. Reddy's) – Failed Stability (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
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India
Brand
Dr. Reddy's Laboratories, Inc.
Lot Codes / Batch Numbers
Lot #: a) D06017, D06018, Exp 9/18, D06028 Exp 10/18, b) D06014, D06015, D06016, Exp 9/18, D06024, D06025, D06026, D06027, Exp 10/2018, c) D06011, D06012, D06013, Exp 9/18, D06020, D06021, D06022, D06023, Exp 10/2018
Products Sold
Lot #: a) D06017, D06018, Exp 9/18; D06028 Exp 10/18; b) D06014, D06015, D06016, Exp 9/18; D06024, D06025, D06026, D06027, Exp 10/2018; c) D06011, D06012, D06013, Exp 9/18; D06020, D06021, D06022, D06023, Exp 10/2018
Dr. Reddy's Laboratories, Inc. is recalling Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tub due to Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testin. 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 stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
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