Dr. Reddy's Laboratories, Inc. Recalls

All product recalls associated with Dr. Reddy's Laboratories, Inc..

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Recall Summary

Total Recalls

23

Past Year

4

Class I (Serious)

3

Most Recent

Nov 2025

Data from FDA, USDA, CPSC, and NHTSA public records. Recall counts vary by company size, industry, and reporting practices. Always check official sources for current information.

Showing 1–20 of 23 recalls

Varenicline Tablets (Dr. Reddy's) – Subpotent Drug (2025)

Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.

Class III

FDANov 11, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Succinylcholine Chloride Injection (Dr. Reddy's) – Stability Issue (2025)

Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.

Class II

FDASep 26, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Omeprazole Capsules (Dr. Reddy's) – Foreign Tablets (2025)

Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.

Class II

FDAJun 30, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Levetiracetam Injection (Dr. Reddy's) – Labeling Error (2025)

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 I

FDAMar 13, 2025Nationwide• Dr. Reddy's Laboratories, Inc.

Javygtor Tablets 100mg (Dr. Reddy's) – Impurity Specifications (2024)

Failed Impurities/Degradation Specifications

Class III

FDANov 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

IBU Tablets (Dr. Reddy's) – Failed Specifications (2024)

Failed Tablet/Capsule Specifications

Class III

FDAOct 29, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Morphine Sulfate Tablets 30mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class II

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Morphine Sulfate Tablets 15mg (Dr. Reddy's) – Impurity Spec Failure (2024)

Failed Impurities/Degradation Specification

Class II

FDAOct 22, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 30mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class II

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 90mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class II

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Cinacalcet Tablets 60mg (Dr. Reddy's) – Nitrosamine Impurity (2024)

CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit

Class II

FDAOct 9, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Ibuprofen 800mg Tablets (Dr. Reddy's) – Impurity Limit Exceeded (2024)

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Class II

FDAAug 6, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Ibuprofen 600mg Tablets (Dr. Reddy's) – Impurity Limit Exceeded (2024)

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Class II

FDAAug 6, 2024Nationwide• Dr. Reddy's Laboratories, Inc.

Ibuprofen 400mg Tablets (Dr. Reddy's) – Impurity Limit Exceeded (2024)

Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.

Class II

FDAAug 6, 2024Nationwide• Dr. Reddy's Laboratories, Inc.