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Dr. Reddy's Laboratories Recalls
165 recalls on record · August 8, 2012 to December 17, 2025 · Drugs
Recalls by year
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Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
December 17, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in
Hazard: Sub potent drug: during the 9-month stability test conducted, the assay value for the affected lot was below specification limit.
October 15, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Int
Hazard: Out-of-Specification (OOS) result during the 6-month stability testing; decreased preservative concentration.
July 23, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Li
Hazard: Presence of foreign tablets/capsules: presence of foreign Divalproex Sodium Extended-Release 250mg tablet in a bottle of omeprazole capsules.
April 23, 2025DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland
Hazard: 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.
December 18, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories I
Hazard: Failed Impurities/Degradation Specifications
November 27, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08
Hazard: Failed Tablet/Capsule Specifications
November 13, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville,
Hazard: Failed Impurities/Degradation Specification
November 13, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenvill
Hazard: Failed Impurities/Degradation Specification
November 6, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India.,
Hazard: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
November 6, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India,
Hazard: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
November 6, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, N
Hazard: CGMP Deviations: Presence of N-nitroso Cinacalcet impurity above FDA recommended interim limit
September 4, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In
Hazard: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
September 4, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In
Hazard: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
September 4, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in In
Hazard: Failed impurities/degradation specifications: results for unknown impurity, were 0.13% and 0.11% respectively, exceeding the 0.10% specification limit.
August 14, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Lab
Hazard: Labeling: Incorrect or Missing Lot and/or Exp Date. Missing lot number and expiration dates on packets
July 10, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shrev
Hazard: Presence of foreign substance.
July 10, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500
Hazard: Failed Impurities/Degradation Specifications: Related Substances
June 5, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laborat
Hazard: Lack of Assurance of Sterility: Leaking vials
May 29, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08
Hazard: Failed Impurities/Degradation Specifications
May 15, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr.
Hazard: Sub-potent Drug; powder discoloration associated with decreased potency
May 15, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distri
Hazard: Sub-potent Drug; powder discoloration associated with decreased potency
February 14, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409
Hazard: Misprint on tablet
February 14, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409
Hazard: Misprint on tablet
January 17, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409
Hazard: Presence of Foreign tablets/capsules - identified as tizanidine 2 mg tablets.
January 17, 2024DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally,
Hazard: Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus capsule found in a bottle of 1 mg Tacrolimus capsules.
November 15, 2023DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton,
Hazard: 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.
July 26, 2023DrugsFDA
Dr Reddy's Laboratories Limited recalls Tizanidine Tablets USP, 4 mg, 1000-Count bottle, Rx Only, Manufactured by Dr. Reddy's Laboratories Limited Srikakulam -
Hazard: Failed dissolution specification: Out of specification results observed in 24-month long term stability testing.
March 1, 2023DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500
Hazard: 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.
December 7, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Ta
Hazard: Failed dissolution specifications
October 12, 2022DrugsFDA
Dr. Reddy's Laboratories, Inc. recalls Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Re
Hazard: Failed Stability Specifications: Out of specification results reported at 12-month stability testing for aluminum content.