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Dr. Reddy's Laboratories, Inc. FDA Recalls
70 recalls on file across drugs, 3 of them Class I and 23 still open. This firm is not matched to a listed company.
Newest first
Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.
| Product |
|---|
| Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in Class IIINov 11, 2025Sub potent drug: during the 9-month stability test conducted |
| Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or IntClass IISep 26, 2025Out-of-Specification (OOS) result during the 6-month stabili |
| Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories LiClass IIJun 30, 2025Presence of foreign tablets/capsules: presence of foreign Di |
| Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Class IMar 13, 2025LABELING: LABEL MIX-UP: The infusion bag is incorrectly labe |
| Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories IClass IIINov 22, 2024Failed Impurities/Degradation Specifications |
| IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08Class IIIOct 29, 2024Failed Tablet/Capsule Specifications |
| Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, Class IIOct 22, 2024Failed Impurities/Degradation Specification |
| Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, GreenvillClass IIOct 22, 2024Failed Impurities/Degradation Specification |
| Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, Class IIOct 9, 2024CGMP Deviations: Presence of N-nitroso Cinacalcet impurity a |
| Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., Class IIOct 9, 2024CGMP Deviations: Presence of N-nitroso Cinacalcet impurity a |
| Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NClass IIOct 9, 2024CGMP Deviations: Presence of N-nitroso Cinacalcet impurity a |
| IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in InClass IIAug 6, 2024Failed impurities/degradation specifications: results for un |
| IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in InClass IIAug 6, 2024Failed impurities/degradation specifications: results for un |
| IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in InClass IIAug 6, 2024Failed impurities/degradation specifications: results for un |
| Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's LabClass IIIJun 26, 2024Labeling: Incorrect or Missing Lot and/or Exp Date. Missing |
| Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, ShrevClass IIJun 7, 2024Presence of foreign substance. |
| Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 Class IIIJun 4, 2024Failed Impurities/Degradation Specifications: Related Substa |
| Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's LaboratClass IIMay 23, 2024Lack of Assurance of Sterility: Leaking vials |
| Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08Class IIIMay 1, 2024Failed Impurities/Degradation Specifications |
| Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Class IApr 8, 2024Sub-potent Drug; powder discoloration associated with decrea |
| Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, DistriClass IApr 8, 2024Sub-potent Drug; powder discoloration associated with decrea |
| Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 Class IIIJan 18, 2024Misprint on tablet |
| Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 Class IIIJan 18, 2024Misprint on tablet |
| Tizanidine Tablets, USP 4mg, 150-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409 Class IIJan 2, 2024Presence of Foreign tablets/capsules - identified as tizanid |
| Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally,Class IIDec 15, 2023Presence of Foreign Tablets/Capsules: One 0.5 mg Tacrolimus |
| Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton,Class IIOct 13, 2023Presence of Foreign Tablet(s)/Capsule(s): A foreign tablet w |
| Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 Class IIFeb 8, 2023Presence of Foreign Tablets/Capsules: Presence of one Tacrol |
| Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release TaClass IIINov 21, 2022Failed dissolution specifications |
| Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. ReClass IIISep 14, 2022Failed Stability Specifications: Out of specification result |
| Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 TabletsClass IIJul 13, 2022FAILED DISSOLUTION SPECIFICATIONS |
| Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 TabletsClass IIJul 13, 2022FAILED DISSOLUTION SPECIFICATIONS |
| Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister Class IIApr 15, 2022Failed Dissolution Specifications |
| Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-39Class IIMar 23, 2022Failed Dissolution Specifications; during long term stabilit |
| Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories LClass IIMar 23, 2022Failed Dissolution Specifications; during long term stabilit |
| Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 53Class IIIMar 16, 2022Failed Impurities/Degradation Specifications: Out of Specifi |
| Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, DiClass IIIFeb 17, 2022Subpotent Drug: Out-of-specification results observed in Ass |
| Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Class IIIJan 19, 2022Failed stability specifications |
| Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 Class IIIJan 19, 2022Failed stability specifications |
| Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 0Class IIIJan 19, 2022Failed stability specifications |
| Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cClass IIIJan 10, 2022Subpotent drug |
| CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 EClass IIIJan 4, 2022Failed Dissolution Specifications |
| Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets Class IIIJan 4, 2022Failed Dissolution Specifications |
| Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPCClass IIIJan 4, 2022Failed Dissolution Specifications |
| Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-RelClass IIIJan 4, 2022Failed Dissolution Specifications |
| QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & CongesClass IIIJan 4, 2022Failed Dissolution Specifications |
| equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-RelClass IIIJan 4, 2022Failed Dissolution Specifications |
| Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USPClass IIIJan 4, 2022Failed Dissolution Specifications |
| Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release TableClass IIIJan 4, 2022Failed Dissolution Specifications |
| Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal DecongestClass IIIJan 4, 2022Failed Dissolution Specifications |
| Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets,Class IIINov 12, 2021Failed dissolution specifications |
| Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-ReleClass IIINov 12, 2021Failed dissolution specifications |
| Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP,Class IIINov 12, 2021Failed dissolution specifications |
| Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release TabletClass IIINov 12, 2021Failed dissolution specifications |
| 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal DecongestaClass IIINov 12, 2021Failed dissolution specifications |
| Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-ReleClass IIINov 12, 2021Failed dissolution specifications |
| Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, DistriClass IIINov 12, 2021Failed dissolution specifications |
| Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP,Class IIINov 12, 2021Failed dissolution specifications |
| Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release TClass IIINov 12, 2021Failed dissolution specifications |
| Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-9Class IIOct 5, 2021Failed Excipient Specifications; product manufactured using |
| Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-9Class IIOct 5, 2021Failed Excipient Specifications; product manufactured using |
| Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-9Class IIOct 5, 2021Failed Excipient Specifications; product manufactured using |
| Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules peClass IIOct 5, 2021CGMP Deviations: Customer complaint for the presence of a st |
| Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-Class IIOct 5, 2021Failed Excipient Specifications; product manufactured using |
| Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's LaClass IIOct 5, 2021Failed Excipient Specifications and Presence of Foreign Tabl |
| Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam DistrClass IIJul 19, 2021Failed Tablet/Capsule Specification: Some tablets are shaved |
| Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories LimitClass IIIJun 4, 2021Failed Impurities/Degradation Specifications: due to presenc |
| Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, BachupallClass IIIMay 4, 2021Failed Impurities -Degradation Specifications:due to presenc |
| Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, IncClass IIFeb 26, 2021Failed Dissolution Specifications: Out-of-specification resu |
| Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-Class IIIFeb 19, 2021Failed Impurities/Degradation Specifications:presence of ATV |
| Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 3Class IIFeb 17, 2021Failed Dissolution Specifications |