Nystatin and Triamcinolone Acetonide Cream USP100 — Class III drug recall D-1518-2019
Terminated recall by Lupin Pharmaceuticals Inc., reported 2019-07-31, distributed nationwide. Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers tes
| Recall number | D-1518-2019 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Lupin Pharmaceuticals Inc., Baltimore, MD, United States |
| Recall initiated | 2019-07-17 |
| Classified | 2019-07-25 |
| Reported by FDA | 2019-07-31 |
| Terminated | 2020-09-14 |
| Distributed | Nationwide (US) |
| Quantity | 33,939 tubes |
| Reason classes | specification failure |
| NDC | 68180-0545, 68180-0545-01, 68180-0545-02, 68180-0545-03 |
| Lot numbers | K800245, K900036, K900153 |
| Expiration dates | 2019-12-20, 2020-09 |
Product
Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-545-01
Reason for recall
Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of containers test at 9 month long term stability condition for upright orientation.
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-1518-2019. 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.