KENALOG — Class III drug recall D-0148-2017
Terminated recall by Sun Pharmaceutical Industries, Inc., reported 2016-11-30, distributed nationwide. Failed Stability Specifications: Low Out of Specification results for alcohol content.
| Recall number | D-0148-2017 |
|---|---|
| Product type | Drug |
| Classification | Class III |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Sun Pharmaceutical Industries, Inc., Cranbury, NJ, United States |
| Recall initiated | 2016-10-28 |
| Classified | 2016-11-22 |
| Reported by FDA | 2016-11-30 |
| Terminated | 2017-10-20 |
| Distributed | Nationwide (US) |
| Quantity | 326,103 bottles |
| Reason classes | specification failure |
| UPC / GTIN / UDI-DI | 00310631093358 |
| Expiration dates | 2016-10-31, 2017-01-31, 2017-04-30, 2017-06-30 |
Product
KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.
Reason for recall
Failed Stability Specifications: Low Out of Specification results for alcohol content.
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-0148-2017. 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.