Zenatane — Class II drug recall D-0886-2017

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-0886-2017`
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	452,290 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	`01/18`, `01KB50598`, `01KB50643`, `01KB50644`, `01KB60062`, `01KB60063`, `01KB60064`, `01KB60065`, `01KB60066`, `01KB60100`, `01KB60101`, `01KB60161`, `01KB60256`, `01KB60257`, `01KB60258`, `01KB60259`, `01KB60260`, `01KB60292`, `01KB60293`, `01KB60294`, `01KB60314`, `01KB60321`, `01KB60333`, `01KB60334`, `01KB60393`, `01KB60394`, `01KB60505`, `01KB60506`, `01KB60538`, `01KB60589`, `03/18`, `04/18`, `05/17`, `05/18`, `07/17`, `07/18`, `08/17`, `08/18`, `09/17`, `11/17` and 76 more

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 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-0886-2017. 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.