Dr. Reddy's Laboratories, Inc.

70 FDA enforcement actions

70 Total Recalls

3 Class I

30 Class II

37 Class III

Firm Details

Product Types: drug
States: NJ

All Recalls

Class III: Low Risk 11/11/2025 drug

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
Class II: Risk 09/26/2025 drug

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
Class II: Risk 06/30/2025 drug

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
Class I: Dangerous 03/13/2025 drug

LABELING: LABEL MIX-UP: The infusion bag is incorrectly labeled as Levetiracetam in 0.82% Sodium Chloride Injection 500 mg/100 mL, while the aluminum overwrap packaging correctly identifies the product as Levetiracetam in 0.75% Sodium Chloride Injection 1,000 mg/100 mL.
Class III: Low Risk 11/22/2024 drug

Failed Impurities/Degradation Specifications
Class III: Low Risk 10/29/2024 drug

Failed Tablet/Capsule Specifications
Class II: Risk 10/22/2024 drug

Failed Impurities/Degradation Specification
Class II: Risk 10/22/2024 drug

Failed Impurities/Degradation Specification
Class II: Risk 10/09/2024 drug

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 10/09/2024 drug

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 10/09/2024 drug

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
Class II: Risk 08/06/2024 drug

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II: Risk 08/06/2024 drug

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class II: Risk 08/06/2024 drug

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
Class III: Low Risk 06/26/2024 drug

Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
Class II: Risk 06/07/2024 drug

Presence of foreign substance.
Class III: Low Risk 06/04/2024 drug

Failed Impurities/Degradation Specifications: Related Substances
Class II: Risk 05/23/2024 drug

Lack of Assurance of Sterility: Leaking vials
Class III: Low Risk 05/01/2024 drug

Failed Impurities/Degradation Specifications
Class I: Dangerous 04/08/2024 drug

Sub-potent Drug; powder discoloration associated with decreased potency
Class I: Dangerous 04/08/2024 drug

Sub-potent Drug; powder discoloration associated with decreased potency
Class III: Low Risk 01/18/2024 drug

Misprint on tablet
Class III: Low Risk 01/18/2024 drug

Misprint on tablet
Class II: Risk 01/02/2024 drug

Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
Class II: Risk 12/15/2023 drug

Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
Class II: Risk 10/13/2023 drug

Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet was found in a bottle of Montelukast Sodium Tablets, USP 10mg, identified as metoprolol 25 mg.
Class II: Risk 02/08/2023 drug

Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg capsules.
Class III: Low Risk 11/21/2022 drug

Failed dissolution specifications
Class III: Low Risk 09/14/2022 drug

Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.
Class II: Risk 07/13/2022 drug

FAILED DISSOLUTION SPECIFICATIONS
Class II: Risk 07/13/2022 drug

FAILED DISSOLUTION SPECIFICATIONS
Class II: Risk 04/15/2022 drug

Failed Dissolution Specifications
Class II: Risk 03/23/2022 drug

Failed Dissolution Specifications; during long term stability testing.
Class II: Risk 03/23/2022 drug

Failed Dissolution Specifications; during long term stability testing.
Class III: Low Risk 03/16/2022 drug

Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
Class III: Low Risk 02/17/2022 drug

Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
Class III: Low Risk 01/19/2022 drug

Failed stability specifications
Class III: Low Risk 01/19/2022 drug

Failed stability specifications
Class III: Low Risk 01/19/2022 drug

Failed stability specifications
Class III: Low Risk 01/10/2022 drug

Subpotent drug
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 01/04/2022 drug

Failed Dissolution Specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class III: Low Risk 11/12/2021 drug

Failed dissolution specifications
Class II: Risk 10/05/2021 drug

CGMP Deviations: Customer complaint for the presence of a staple co-mingled with capsules within the bottle.
Class II: Risk 10/05/2021 drug

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II: Risk 10/05/2021 drug

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II: Risk 10/05/2021 drug

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II: Risk 10/05/2021 drug

Failed Excipient Specifications and Presence of Foreign Tablets/Capsules; product manufactured using an excipient found to be OOS for conductivity and some Ezetimibe and Simvastatin Tablets, 10 mg/10 mg were found in the bottle
Class II: Risk 10/05/2021 drug

Failed Excipient Specifications; product manufactured using an excipient found to be OOS for conductivity
Class II: Risk 07/19/2021 drug

Failed Tablet/Capsule Specification: Some tablets are shaved
Class III: Low Risk 06/04/2021 drug

Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities
Class III: Low Risk 05/04/2021 drug

Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities
Class II: Risk 02/26/2021 drug

Failed Dissolution Specifications: Out-of-specification results observed for dissolution during stability testing.
Class III: Low Risk 02/19/2021 drug

Failed Impurities/Degradation Specifications:presence of ATV cyclo IP and FP, Dihydroxy epoxy and Dieto epoxy impurities
Class II: Risk 02/17/2021 drug

Failed Dissolution Specifications

Data from FDA openFDA enforcement reports. This site is not affiliated with or endorsed by the FDA. Recall information may be updated by the FDA at any time.