Dr. Reddy's Laboratories Ltd.

50 FDA enforcement records linked to this company.

• recall — Class III2025-12-17

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

• recall — Class II2025-10-15

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

• recall — Class II2025-07-23

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

• recall — Class I2025-04-23

  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.

• recall — Class III2024-12-18

  Failed Impurities/Degradation Specifications

• recall — Class III2024-11-27

  Failed Tablet/Capsule Specifications

• recall — Class II2024-11-13

  Failed Impurities/Degradation Specification

• recall — Class II2024-11-13

  Failed Impurities/Degradation Specification

• recall — Class II2024-11-06

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

• recall — Class II2024-11-06

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

• recall — Class II2024-11-06

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

• recall — Class II2024-09-04

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

• recall — Class II2024-09-04

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

• recall — Class II2024-09-04

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

• recall — Class III2024-08-14

  Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets