Atorvastatin Calcium Tablet
FDA Recall NDC 55111-121
FDA Enforcement Report: View Recall Date, Reasons, and Safety Status
Active & Historical Enforcement Reports
The FDA has identified 10 recorded enforcement report(s) associated with Atorvastatin Calcium (NDC 55111-121). A significant event, classified as Class III, was initiated on Jun 04, 2021 by Dr. Reddy's Laboratories Limited. The reported reason for this action was: "Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities"
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
D-0629-2021D-0599-2021D-0291-2021D-1079-2018D-0887-2018D-0886-2018D-0888-2018D-0418-2018D-0419-2018D-0420-2018
Class III Terminated
Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Jun 04, 2021
Jun 23, 2021
5984 bottles
Recall Profile & Regulatory Data
Event ID
88041
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide within the United States
Termination Date
Feb 16, 2023
Product Description
Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.
Batch or Lot Expiration Information
Lot# : C905064, C905065, Exp. Date 07/2021
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
Class III Terminated
Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
May 04, 2021
Jun 02, 2021
2980 500 count -bottles
Recall Profile & Regulatory Data
Event ID
87879
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Feb 16, 2023
Product Description
Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.
Batch or Lot Expiration Information
Lot# C905063, Exp 07/2021
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
February 2021 Class III Recall: Failed Impurities/Degradation Specifications
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Feb 19, 2021
Mar 10, 2021
10,440 90-count and 224,710 500-count bottles
Recall Profile & Regulatory Data
Event ID
87365
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Distributed Nationwide in the USA
Termination Date
Sep 07, 2023
Product Description
Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 INDIA
Batch or Lot Expiration Information
Lot# a) T900406, exp 3/2021 b) T000078 exp 12/2021 T000079 exp 12/2021 T000080 exp 12/2021 T000081 exp 12/2021 T000082 exp 12/2021 T000083 exp 12/2021 T000084 exp 12/2021 T000085 exp 12/2021 T000086 exp 12/2021 T000087 exp 12/2021 T000088 exp 1/2022 T000311 exp 1/2022 T000312 exp 1/2022 T000313 exp 1/2022 T000314 exp 1/2022 T000315 exp 1/2022 T000316 exp 1/2022 T000317 exp 1/2022 T000318 exp 1/2022 T000319 exp 1/2022 T000320 exp 1/2022 T000500 exp 2/2022 T000501 exp 2/2022 T000502 exp 2/2022 T000503 exp 2/2022 T000504 exp 2/2022 T000505 exp 2/2022 T000506 exp 2/2022 T000507 exp 2/2022 T000508 exp 2/2022 T000509 exp 3/2022 T000510 exp 3/2022 T000647 exp 3/2022 T000648 exp 3/2022 T000651exp 3/2022 T000652 exp 3/2022 T000653 exp 3/2022 T000654 exp 3/2022 T000875 exp 4/2022 T000876 exp 4/2022 T000877 exp 4/2022 T000878 exp 4/2022 T000879 exp 4/2022 T000880 exp 4/2022 T000881 exp 4/2022 T000882 exp 4/2022 T000883 exp 4/2022 T000884 exp 4/2022 T001120 exp 5/2022 T001121 exp 5/2022 T001122 exp 5/2022 T001124 exp 5/2022 T001125 exp 5/2022 T001126 exp 5/2022 T001127 exp 5/2022 T001128 exp 5/2022 T001129 exp 5/2022 T001130 exp 5/2022 T001260 exp 5/2022 T001261 exp 5/2022 T900506 exp 4/2021 T900507 exp 4/2021 T900508 exp 4/2021 T900655 exp 5/2021 T900656 exp 5/2021 T900657 exp 5/2021 T900658 exp 5/2021 T900659 exp 5/2021 T900673 exp 5/2021 T900674 exp 5/2021 T901024 exp 7/2021 T901025 exp 7/2021 T901026 exp 7/2021 T901027 exp 7/2021 T901029 exp 7/2021 T901030 exp 7/2021 T901031 exp 7/2021 T901032 exp 7/2021 T901033 exp 7/2021 T901424 exp 10/2021 T901425 exp 10/2021 T901426 exp 10/2021 T901427 exp 10/2021 T901428 exp 10/2021 T901429 exp 10/2021 T901430 exp 10/2021 T901431 exp 10/2021 T901432 exp 10/2021 T901433 exp 10/2021 T901568 exp 10/2021 T901569 exp 10/2021 T901570 exp 11/2021 T901571 exp 11/2021 T901572 exp 11/2021 T901573 exp 11/2021 T901574 exp 11/2021 T901575 exp 11/2021 T901576 exp 11/2021 T901577 exp 11/2021
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
August 2018 Class III Recall: Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Recall Number
Class III Terminated
Failed Impurities/Degradation Specifications - OOS was observed for ATV Cyclo FP Impurity and Total Degradation Impurities tested at the 18 month stability time point in Atorvastatin Calcium Tablets 40 mg 500 tablets.
Aug 02, 2018
Aug 22, 2018
2280 bottles
Recall Profile & Regulatory Data
Event ID
80675
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
U.S.A. Nationwide
Termination Date
Apr 15, 2020
Product Description
Atorvastatin Calcium tablets, 40 mg, 500-count bottle, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 India, NDC 55111-123-05
Batch or Lot Expiration Information
Lot# T60045
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
Class III Terminated
Failed Impurities/Degradation Specifications
Jun 12, 2018
Jun 27, 2018
44,894 bottles
Recall Profile & Regulatory Data
Event ID
80275
Classification
Class III
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 08, 2019
Product Description
Atorvastatin Calcium Tablets, 20 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-122-90
Batch or Lot Expiration Information
Lot# : T600328, Exp 07/18; T700214, T700216, Exp 04/19
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
Class III Terminated
Failed Impurities/Degradation Specifications
Jun 12, 2018
Jun 27, 2018
55,126 bottles
Recall Profile & Regulatory Data
Event ID
80275
Classification
Class III
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 08, 2019
Product Description
Atorvastatin Calcium Tablets, 10 mg*, 90-count bottle, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA, NDC 55111-121-90
Batch or Lot Expiration Information
Lot# : T600327, Exp 07/18; T700213, T700215, Exp 04/19
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
Class III Terminated
Failed Impurities/Degradation Specifications
Jun 12, 2018
Jun 27, 2018
130,081 bottles
Recall Profile & Regulatory Data
Event ID
80275
Classification
Class III
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 08, 2019
Product Description
Atorvastatin Calcium Tablets, 40 mg*, packaged as a) 90-count bottle (NDC 55111-123-90 and b) 500-count bottle (NDC 55111-123-05), Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 INDIA
Batch or Lot Expiration Information
Lot# : a) T600392, T600384, T600353, Exp 08/18; T600427, Exp 09/18; T600435, Exp 10/18; T600492, Exp 11/18; T700006, T700014, T700033, T700035, T700036 12/18; b) T600407, Exp 09/18
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
January 2018 Class III Recall: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Recall Number
Class III Terminated
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Jan 29, 2018
Feb 07, 2018
a) 34,125; b) 3,540 bottles
Recall Profile & Regulatory Data
Event ID
79065
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 07, 2018
Product Description
Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-121-05
Batch or Lot Expiration Information
Lot# Lot numbers: a) T600125, 3/2018; T600201, T600248 5/2018, b) T600125, 3/2018; T600201, and T600248, 5/2018
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
January 2018 Class III Recall: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Recall Number
Class III Terminated
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Jan 29, 2018
Feb 07, 2018
a) 28,941 and b) 2,928 bottles
Recall Profile & Regulatory Data
Event ID
79065
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 07, 2018
Product Description
Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05
Batch or Lot Expiration Information
Lot# Lot numbers: a) T600126, 3/2018; T600202 and T600247 5/2018, b) T600126, 3/2018; T600202, and T600247, 5/2018
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
January 2018 Class III Recall: Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Recall Number
Class III Terminated
Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability
Jan 29, 2018
Feb 07, 2018
12,579 bottles
Recall Profile & Regulatory Data
Event ID
79065
Classification
Class III
Enforcement Status
Terminated
Recalling Firm
Dr. Reddy's Laboratories, Inc.
Voluntary / Mandated
Voluntary: Firm initiated
Distribution Pattern
Nationwide
Termination Date
Dec 07, 2018
Product Description
Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-123-05
Batch or Lot Expiration Information
Lot# Lot number: T600279, 6/2018
Affected Packages Involved in this Recall
55111-121-30Product
55111-121-60Product
55111-121-90Product
55111-121-05Product
55111-121-10Product
55111-122-30Product
55111-122-60Product
55111-122-90Product
55111-122-05Product
55111-122-10Product
55111-123-30Product
55111-123-60Product
55111-123-90Product
55111-123-05Product
55111-123-10Product
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.
