Nystatin and Triamcinolone Acetonide Cream — Class II drug recall D-0007-2019
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2018-10-10, distributed nationwide. Failed stability specifications - An out of specification result was observed for the test parameter : composi
| Recall number | D-0007-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Dr. Reddy's Laboratories, Inc., Princeton, NJ, United States |
| Recall initiated | 2018-09-21 |
| Classified | 2018-10-04 |
| Reported by FDA | 2018-10-10 |
| Terminated | 2023-02-17 |
| Distributed | Nationwide (US) |
| Quantity | 35,020 tubes |
| Reason classes | specification failure |
| NDC | 43598-0431-30, 43598-0431-44, 43598-0431-60 |
| Expiration dates | 2018-10 |
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
Reason for recall
Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
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-0007-2019. 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.