Zenatane — Class II drug recall D-0883-2017
Terminated recall by Dr. Reddy's Laboratories, Inc., reported 2017-06-14, distributed nationwide. Failed Dissolution Specifications: out of specification results observed for low dissolution.
| Recall number | D-0883-2017 |
|---|---|
| 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 | 2017-05-22 |
| Classified | 2017-06-02 |
| Reported by FDA | 2017-06-14 |
| Terminated | 2018-11-19 |
| Distributed | Nationwide (US) |
| Quantity | 13,221 cartons |
| Reason classes | specification failure |
| NDC | 55111-0113, 55111-0113-78, 55111-0113-79, 55111-0113-81, 55111-0135, 55111-0135-79, 55111-0135-81, 55111-0136, 55111-0136-79, 55111-0136-81, 55111-0137, 55111-0137-79, 55111-0137-81 |
| Lot numbers | 02/18, 06/17, 08/17, KB50471, KB50710, KB50710A, KB60198 |
Product
Zenatane (isotretinoin) Capsules, USP, 10 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kurkumbh Village, Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-135-81
Reason for recall
Failed Dissolution Specifications: out of specification results observed for low dissolution.
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-0883-2017. 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.