FDA Drug recall D-0098-2017
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pu…
- FDA Drug
- Class III
- terminated
- Published 2016-10-19
On 2016-10-19 the FDA classified a Class III recall of ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pu… by Dr Reddy S Laboratories, citing failed Dissolution Specifications.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0098-2017 |
| Classification | Class III |
| Status | terminated |
| Initiated | 2016-08-29 |
| Published | 2016-10-19 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
ZENATANE (isotretinoin capsules USP) 20 mg, 30 capsules per prescription pack, Rx Only, Manufactured by: Cipla Limited, Kurkumbh Village Pune 4138012 India, Manufactured for: Dr. Reddy's Laboratories Limited Bachupally 500 090 India, NDC 55111-136-81
Reason
Failed Dissolution Specifications
Identifiers
| ndc | 55111-135-79 |
|---|---|
| ndc | 55111-135-81 |
| ndc | 55111-136-79 |
| ndc | 55111-136-81 |
| ndc | 55111-137-79 |
| ndc | 55111-137-81 |
| ndc | 55111-113-79 |
| ndc | 55111-113-81 |
| ndc | 55111-113-78 |
| code_info | Lot # 79KB60205; Exp. 02/18 |
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0098-2017%22
RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.