Triamcinolone Acetonide Lotion USP — Class III drug recall D-1441-2014
Terminated recall by Fougera Pharmaceuticals Inc., reported 2014-07-23, distributed nationwide. Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification
| Recall number | D-1441-2014 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Fougera Pharmaceuticals Inc., Melville, NY, United States |
| Recall initiated | 2014-07-03 |
| Classified | 2014-07-17 |
| Reported by FDA | 2014-07-23 |
| Terminated | 2015-12-07 |
| Distributed | Nationwide (US) |
| Quantity | 3,594 bottles |
| NDC | 00168-0336-60 |
| Lot numbers | 849R |
| Expiration dates | 2015-04 |
Product
Triamcinolone Acetonide Lotion USP, 0.025%, 60 mL Bottle, Rx Only, For Dermatologic Use Only, Not for Ophthalmic Use, E. Fougera & Co, A Division of Fougera Pharmaceuticals Inc., Melville, New York, 11747, NDC 0168-0336-60.
Reason for recall
Failed PH Specifications: It has been determined that the pH of the lots recalled, may not meet specification at expiry.
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-1441-2014. 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.