Dr. Reddy's Laboratories, Inc.

Bridgewater, NJ, United States

163

Total Recalls

5

Class I Recalls

23

Ongoing Recalls

Recalls by Dr. Reddy's Laboratories, Inc.

FDA Drug Class III Terminated

Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy & Congestion, 12 Hour, 30 Tablets, Distributed by: Rugby Laboratories,

November 12, 2021 Dr. Reddy's Laboratories, Inc. 2184 cartons units
FDA Drug Class III Terminated

Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablets USP, Allergy and Congestion, 30 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ, 08640, Made in I

November 12, 2021 Dr. Reddy's Laboratories, Inc. 2,928 cartons units
FDA Drug Class III Terminated

Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets, USP, 20 Extended-Release Tablets, Distributed by: Rite Aid, 30 Hunter Lane, Camp Hill, PA 17011, NDC

November 12, 2021 Dr. Reddy's Laboratories, Inc. 4896 cartons units
FDA Drug Class III Terminated

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, 30 Extended-Release Tablets USP, Distributed By CVS Pharmacy Inc., One CVS Drive, Woonsocket, RI 029

November 12, 2021 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class III Terminated

12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg Antihistamine I Nasal Decongestant, 20 Extended-Release Tablets USP, Distributed By Cardinal Health, Dublin, Oh

November 12, 2021 Dr. Reddy's Laboratories, Inc. 2496 cartons units
FDA Drug Class III Terminated

Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Extended Release Tablets, USP, 30 Extended-Release Tablets USP, Distributed By Walmart Inc., Bentonville, AR 72716, Product o

November 12, 2021 Dr. Reddy's Laboratories, Inc. 9,984 cartons units
FDA Drug Class III Terminated

Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets, 20 extended-release tablets, Distributed by: CVS Pharmacy, Inc., One CVS Driv

November 12, 2021 Dr. Reddy's Laboratories, Inc. 14976 cartons units
FDA Drug Class III Terminated

Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets USP Allergy & Congestion, 20 Tablets, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, NDC 43598-823-14.

November 12, 2021 Dr. Reddy's Laboratories, Inc. 5016 cartons units
FDA Drug Class II Terminated

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, a) 30 count (NDC 43598-743-30), b) 90 count (NDC 43598-743-90) bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shrevepor

October 5, 2021 Dr. Reddy's Laboratories, Inc. a) 11,590 bottles b) 3,585 bottles units
FDA Drug Class II Terminated

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/10 mg, a) 90 count (NDC 43598-742-90) and b) 1000 count (NDC 43598-742-10) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shre

October 5, 2021 Dr. Reddy's Laboratories, Inc. a) 776 bottles, b) 84 bottles units
FDA Drug Class II Terminated

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/40 mg, 500 count bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106, USA, Distributed by: Dr. Reddy's Labora

October 5, 2021 Dr. Reddy's Laboratories, Inc. 696 bottles units
FDA Drug Class II Terminated

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/80 mg, a) 30 count (NDC 43598-745-30), b) 90 count (NDC 43598-745-90), and c) 500 count (NDC 43598-745-05) bottles, Rx Only, Manufactured by: Dr. R

October 5, 2021 Dr. Reddy's Laboratories, Inc. a) 3,444 bottles b) 469 bottles c) 142 bottles units
FDA Drug Class II Terminated

Dr. Reddy's Ezetimibe and Simvastatin Tablets, 10 mg/20 mg, a) 30 count (NDC 43598-744-30), b) 90 count (NDC 43598-744-90) bottles, Rx only, Manufactured by: Dr. Reddy's Laboratories LA LLC, Shrevepor

October 5, 2021 Dr. Reddy's Laboratories, Inc. a) 30,839 bottles, b) 3,830 bottles units
FDA Drug Class II Terminated

Omeprazole Delayed-Release Capsules, 20 mg* (equivalent to 20.6 mg omeprazole magnesium), 24 Hour, 14-count capsules per bottle within a carton, Distributed by Cardinal Health, Dublin, OH 43017, NDC

October 5, 2021 Dr. Reddy's Laboratories, Inc. 8,976 bottles units
FDA Drug Class II Terminated

Tizanidine HCl Tablets, USP 4 mg, 150-count bottles, Rx only, Mfd By: Dr. Reddy's Laboratories limited, Srikakulam District, 532 409 INDIA, NDC 55111-180-15.

July 19, 2021 Dr. Reddy's Laboratories, Inc. 37560 bottles units
FDA Drug Class III Terminated

Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Reddy's Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, 500-090 India, NDC 55111-121-05.

June 4, 2021 Dr. Reddy's Laboratories, Inc. 5984 bottles units
FDA Drug Class III Terminated

Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: Dr. Reddy's Laboratories Limited, Bachupally 500 090, India, NDC 55111-121-05.

May 4, 2021 Dr. Reddy's Laboratories, Inc. 2980 500 count -bottles units
FDA Drug Class II Terminated

Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08540; NDC 43598-350-01.

February 26, 2021 Dr. Reddy's Laboratories, Inc. 16,449 bottles units
FDA Drug Class III Terminated

Atorvastatin Calcium Tablets, 40mg, packaged in a) 90-count bottles, NDC 55111-123-90; b) 500-count bottles, NDC 55111-123-05; Rx only, Mfd By: Dr. Reddy's Laboratories Limited Srikakulam - 532 409 I

February 19, 2021 Dr. Reddy's Laboratories, Inc. 10,440 90-count and 224,710 500-count bottles units
FDA Drug Class II Terminated

Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-344-90); and b) For Institutional Use Only 30-count (3 x 10 unit-dose) tablets per carton (NDC 43598-344-31); Rx only, Distr

February 17, 2021 Dr. Reddy's Laboratories, Inc. a) 1350 bottles; b) 147 cartons units
FDA Drug Class III Terminated

Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10

April 24, 2020 Dr. Reddy's Laboratories, Inc. 1752 bottles units
FDA Drug Class I Terminated

Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11) packaged in 25 x 1 mL Single-Dose Ampules per carton (NDC 43598-405-16); Rx Only, Distributor: Dr. Reddy's Laboratories I

March 16, 2020 Dr. Reddy's Laboratories, Inc. 10943 cartons units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, 40 count bottles, NDC 11673-849-40 (Target) OTC.

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 75 mg 30 count bottles (NDC 30142-131-30) (Kroger)

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 75 mg, NDC 57896-715 (GeriCare) OTC.

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 63868-480-24), b.) 50-count bottles (NDC 63868-480-50) (CDMA) OTC

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 75 mg, a.) 30- count bottles (NDC 0363-0131-30), b.) 80-count bottles (NDC 0363-0131-80) (Walgreens) OTC

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, NDC 57896-717 (GeriCare) OTC

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 30142-505-34), b.) 50 count bottles (NDC 30142-505-50) (Kroger) OTC

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, a.) 95 count bottles (NDC 43598-808-62), b.) 220 count bottles (NDC 43598-808-65) (HCA) OTC.

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Dr. Reddy's: Ranitidine Capsules 150 mg, Rx a.) 60 count bottles (NDC 55111-129-60) b.) 500 count bottles (NDC 55111-129-05)

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Dr. Reddy's Ranitidine Tablets, USP 150 mg, 24 count bottles, NDC 55111-404-34 (OTC)

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 0363-0010-34), b.) 65 count bottles (NDC 0363-0010-61) , c.) 95 count bottles (NDC 0363-0010-62), d.) 200 count bottles (NDC 0363-0010-01)

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Dr. Reddy's Ranitidine Capsules, USP 300 mg, a.) 30 count bottles (NDC 55111-130-30) b.) 100 count bottles (NDC 55111-130-01)

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, a.) 24 count bottles (NDC 71713-203-02), b.)95 count bottles (NDC 71713-203-05) (Thirty Madison) OTC.

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 75 mg, a.) 30 count bottles (NDC 69842-871-30) b.) 80 count bottles (NDC 69842-871-80) c.)160 count bottles (NDC 69842-871-37) (CVS) OTC

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, 190 count bottles (2x95) Tray (Sam's Club) OTC, NDC 150062076 UPC Code 078742089720

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets, USP 150 mg, a.) 65 count bottles (NDC 49035-404-61) b.) 130 count bottles (NDC 49035-404-13) c.) 220 count bottles (NDC 49035-404-65) (Walmart) OTC

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Ranitidine Tablets 75 mg, a.) 30 count bottles (NDC 63868-482-30), 60 count bottles (NDC 63868-482-60) (CDMA) OTC

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Completed

Dr. Reddy's Ranitidine Tablets, USP 75 mg, 60 count bottles, NDC 55111-131-60, (OTC)

October 1, 2019 Dr. Reddy's Laboratories, Inc. N/A units
FDA Drug Class II Terminated

Divalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally

April 11, 2019 Dr. Reddy's Laboratories, Inc. 33,958 bottles units
FDA Drug Class II Terminated

Docetaxel Injection USP, 80 mg/4 mL, (20 mg/mL), One-Vial Formulation, Rx only, Mfd By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, Andhra Pradesh, INDIA, NDC 43598-259-40.

March 6, 2019 Dr. Reddy's Laboratories, Inc. 5,755 vials units
FDA Drug Class III Terminated

Esomeprazole Magnesium Delayed-Release Capsules USP, 40mg*, a) 90-count bottle (NDC 43598-510-90) b) 1000 count bottle (NDC 43598-510-10), Rx only, Mfd By: Dr. Reddy's Laboratories Limited Bachupally

February 6, 2019 Dr. Reddy's Laboratories, Inc. 40,592, 90 and 1,000 count bottles units
FDA Drug Class II Terminated

Divalproex Sodium Extended-release Tablets, USP 250 mg, 100-count bottle, Rx only, Mfd.By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 India NDC 55111-533-01

January 31, 2019 Dr. Reddy's Laboratories, Inc. 10,656 bottles units
FDA Drug Class II Terminated

Ezetimibe and Simvastatin Tablets 10mg/80 mg, 1000-count bottles, Rx only, Manufactured by: Teva Pharmaceuticals Ind. Ltd. Jerusalem, 9777402, Israel; Distributed by: Dr. Reddy's Laboratories Inc. P

January 15, 2019 Dr. Reddy's Laboratories, Inc. 118 bottles units
FDA Drug Class II Terminated

Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

December 10, 2018 Dr. Reddy's Laboratories, Inc. 4,404 (30 count blister packs) units
FDA Drug Class II Terminated

Clopidogrel Tablets, USP, 300 mg, 30 (5 x 6 unit-dose) count blister pack, Rx only, Manufactured by Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, India, NDC 55111-671-31

November 7, 2018 Dr. Reddy's Laboratories, Inc. 4,212 (30-count blister pack) units
FDA Drug Class I Terminated

Levetiracetam in 0.54 % Sodium Chloride Injection 1,500/mg/100mL (15mg/mL), For intravenous Infusion Only, 1 x 100 mL Infusion bag, Manufactured by: Gland Pharma Limited Hyderabad - 500 043, India Dis

October 26, 2018 Dr. Reddy's Laboratories, Inc. 2770 bags; 277 selling units units
FDA Drug Class II Terminated

Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Dis

September 21, 2018 Dr. Reddy's Laboratories, Inc. 35020 tubes units
FDA Drug Class III Terminated

Zoledronic Acid Injection, 5 mg/100 mL (0.05 mg/mL) One 100ml Single-Dose Bottle, Rx Only. NOVAPLUS Mfd By: Gland Pharma Limited D.P. Pally - 500 043 India: Mfd. For: Dr. Reddy's Laboratories Limited

September 12, 2018 Dr. Reddy's Laboratories, Inc. 10,530 vials units