FDA Drug recall D-0885-2017
Zenatane (isotretinoin) Capsules, USP, 30 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, 30 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-0885-2017 |
| 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, 30 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 55111-113-81
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 #: KB50414, KB50456, Exp 05/17; KB50457, KB50458, KB50459, KB50460, Exp 06/17; KB50580, KB50581, KB50582, KB50583,…Lot #: KB50414, KB50456, Exp 05/17; KB50457, KB50458, KB50459, KB50460, Exp 06/17; KB50580, KB50581, KB50582, KB50583, KB50599, KB50600, Exp 07/17; KB50646, KB50647, KB50721, KB50722, KB50723, KB50724, Exp 09/17; KB50833, KB50834, KB50835, KB50836, KB50837, Exp 10/17; KB50902, KB50903, KB50904, Exp 11/17; KB60037, KB60038, KB60039, KB60040, KB60041, Exp 12/17; KB60109, KB60110, KB60111, KB60112, KB60113, Exp 01/18; 01KB60249, 01KB60266, 01KB60268, 01KB60269, 01KB60284, Exp 03/18; 01KB60369, 01KB60372, 79KB60368, 79KB60371, Exp 05/18; 79KB60507, 79KB60508, 79KB60509, 79KB60510, 79KB60511, 79KB60512, 79KB60513, 79KB60514, 79KB60515, 79KB60516, Exp 07/18; 79KB60570, 79KB60571, 79KB60585, 79KB60586, Exp 08/18; |
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-0885-2017%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.