FDA Drug recall D-0886-2017
Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kur…
- FDA Drug
- Class II
- terminated
- Published 2017-06-14
On 2017-06-14 the FDA classified a Class II recall of Zenatane (isotretinoin) Capsules, USP, 40 mg, 30-count (3 x 10 Prescription Packs) per carton, Rx Only, Manufactured By: Cipla Limited, Kur… by Dr Reddy S Laboratories, citing failed Dissolution Specifications: out of specification results observed for low dissolution.
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-0886-2017 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2017-05-22 |
| Published | 2017-06-14 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Dr Reddy S Laboratories |
| Distribution | US |
Product
Zenatane (isotretinoin) Capsules, USP, 40 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 55111-137-81
Reason
Failed Dissolution Specifications: out of specification results observed for low dissolution.
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 #: KB50363, KB50364, KB50365, KB50366, KB50367, KB50368, KB50369, KB50370, KB50371, Exp 05/17; 01KB50598, KB50541,…Lot #: KB50363, KB50364, KB50365, KB50366, KB50367, KB50368, KB50369, KB50370, KB50371, Exp 05/17; 01KB50598, KB50541, KB50542, KB50543, KB50544, KB50545, KB50546, KB50547, KB50548, KB50549, KB50550, KB50551, Exp 07/17; 01KB50643, 01KB50644, KB50640, KB50641, KB50642, KB50645, Exp 08/17; KB50715, KB50716, KB50717, KB50718, KB50719, KB50720, KB50757, KB50758, KB50759, KB50760, KB50761, Exp 09/17; KB50872, KB50874, KB50875, KB50876, KB50916, KB50938, KB50943, Exp 11/17; 01KB60062, 01KB60063, 01KB60064, 01KB60065, 01KB60066, 01KB60101, KB60025, KB60026, KB60027, KB60028, KB60029, KB60030, KB60031, KB60032, KB60059, KB60060, KB60061, Exp 12/17; 01KB60100, 01KB60161, Exp 01/18; 01KB60256, 01KB60257, 01KB60258, 01KB60259, 01KB60260, Exp 03/18; 01KB60292, 01KB60293, 01KB60294, 01KB60314, 01KB60321, 01KB60333, 01KB60334, 79KB60295, 79KB60296, 79KB60332, 79KB60335, 79KB60346, Exp 04/18; 01KB60393, 01KB60394, 79KB60390, 79KB60391, 79KB60392, Exp 05/18; 01KB60505, 01KB60506, 01KB60538, 79KB60502, |
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-0886-2017%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.