Zenatane Capsule, Gelatin Coated
FDA Recall NDC 55111-113
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 8 recorded enforcement report(s) associated with Zenatane (NDC 55111-113). A significant event, classified as Class II, was initiated on May 22, 2017 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Dissolution Specifications: out of specification results observed for low dissolution."
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
This specific recall has a current status of TERMINATED, indicating that the FDA considers the recall process finished or the product successfully recovered.
Reported Recall Events
Class II Terminated
Failed Dissolution Specifications: out of specification results observed for low dissolution.
May 22, 2017
Jun 14, 2017
13,221 cartons
Recall Profile & Regulatory Data
Event ID
77353
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Nov 19, 2018
Product Description
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
Batch or Lot Expiration Information
Lot# : KB50471, Exp 06/17; KB50710, KB50710A, Exp 08/17; KB60198, Exp 02/18
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
Class II Terminated
Failed Dissolution Specifications: out of specification results observed for low dissolution.
May 22, 2017
Jun 14, 2017
223,650 cartons
Recall Profile & Regulatory Data
Event ID
77353
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Nov 19, 2018
Product Description
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
Batch or Lot Expiration Information
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
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
Class II Terminated
Failed Dissolution Specifications: out of specification results observed for low dissolution.
May 22, 2017
Jun 14, 2017
89,118 cartons
Recall Profile & Regulatory Data
Event ID
77353
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Nov 19, 2018
Product Description
Zenatane (isotretinoin) Capsules, USP, 20 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 55111-136-81
Batch or Lot Expiration Information
Lot# : KB50361, KB50362, Exp 05/17; KB50540, Exp 07/17; KB50638, KB50639, Exp 08/17; KB50725, KB50726, KB50755, KB50756, Exp 09/17; 01KB60255, 79KB60252, 79KB60253, 79KB60254, Exp 03/18; 01KB60347, 01KB60348, 01KB60349, 01KB60350, 79KB60351, Exp 05/18; 01KB60421, 01KB60422, 01KB60423, 79KB60419, 79KB60420, Exp 06/18
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
Class II Terminated
Failed Dissolution Specifications: out of specification results observed for low dissolution.
May 22, 2017
Jun 14, 2017
452,290 cartons
Recall Profile & Regulatory Data
Event ID
77353
Classification
Class II
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide in the USA and Puerto Rico
Termination Date
Nov 19, 2018
Product Description
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
Batch or Lot Expiration Information
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, 79KB60503, 79KB60504, 79KB60535, 79KB60536, 79KB60537, 79KB60539, 79KB60542, Exp 07/18; 01KB60589, 79KB60566, 79KB60567, 79KB60568, 79KB60569, 79KB60587, 79KB60588, Exp 08/18
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
February 2017 Class III Recall: Failed dissolution specifications - low dissolution results at S3 stage.
Recall Number
Class III Terminated
Failed dissolution specifications - low dissolution results at S3 stage.
Feb 15, 2017
Mar 08, 2017
4032 cartons
Recall Profile & Regulatory Data
Event ID
76539
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 19, 2018
Product Description
Zenatane (isotretinoin) capsules, 40 mg, packaged in 30-count cartons (3 x 10 blister cards), 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
Batch or Lot Expiration Information
Lot# 01KB60250, Exp 3/18
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
February 2017 Class III Recall: Failed dissolution specifications - low dissolution results at S3 stage.
Recall Number
Class III Terminated
Failed dissolution specifications - low dissolution results at S3 stage.
Feb 15, 2017
Mar 08, 2017
4404 cartons
Recall Profile & Regulatory Data
Event ID
76539
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 19, 2018
Product Description
Zenatane (isotretinoin) capsules, 10 mg, packaged in 30-count cartons (3 x 10 blister cards), 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
Batch or Lot Expiration Information
Lot# KB60197, Exp 2/18
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
February 2017 Class III Recall: Failed dissolution specifications - low dissolution results at S3 stage.
Recall Number
Class III Terminated
Failed dissolution specifications - low dissolution results at S3 stage.
Feb 15, 2017
Mar 08, 2017
12132 cartons
Recall Profile & Regulatory Data
Event ID
76539
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S. Nationwide
Termination Date
Dec 19, 2018
Product Description
Zenatane (isotretinoin) capsules, 20 mg, packaged in 30-count cartons (3 x 10 blister cards), Rx Only, Manufactured By:Cipla Limited Kurkumbh Village Pune 413802 India, Manufactured For: Dr. Reddy's Laboratories, Bachupally 500 090 India, NDC 55111-136-81
Batch or Lot Expiration Information
Lot# KB50877, KB50878, Exp 11/17; KB50878, 01KB60251, Exp 3/18
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
Class III Terminated
Failed Dissolution Specifications
Aug 29, 2016
Oct 19, 2016
3,858 prescription packs (115,680 capsules)
Recall Profile & Regulatory Data
Event ID
75162
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
nationwide
Termination Date
Nov 08, 2019
Product Description
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
Batch or Lot Expiration Information
Lot# 79KB60205; Exp. 02/18
Affected Packages Involved in this Recall
55111-135-79Product
55111-135-81Product
55111-136-79Product
55111-136-81Product
55111-137-79Product
55111-137-81Product
55111-113-79Product
55111-113-81Product
55111-113-78Product
About FDA Recall Enforcement Reports
FDA recall data documents classified recall actions associated with a product. Most recalls are limited to specific lots, batches, or package configurations rather than every unit of a drug.
If a recall is listed for an NDC, review the affected lot information and package details carefully. Patients and healthcare professionals should confirm whether a specific product in hand matches the lot or package information before assuming it is affected.
