Dr. Reddy's Laboratories, Inc.

FDA Drug Class III Ongoing

Varenicline Tablets, 1mg, 56 Tablets, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-908-56

November 11, 2025 Dr. Reddy's Laboratories, Inc. 4800 54-count bottles units

FDA Drug Class II Ongoing

Succinylcholine Chloride Injection, USP, 200 mg/10 mL (20 mg/mL), 25 x 10 mL Multiple-Dose Vials, For Intravenous or Intramuscular use, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton,

September 26, 2025 Dr. Reddy's Laboratories, Inc. 571 vials units

FDA Drug Class II Ongoing

Omeprazole Delayed-release Capsules, USP, 20mg, 1000-count bottle, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, Manufactured for: Qualient Pharmaceuticals He

June 30, 2025 Dr. Reddy's Laboratories, Inc. 1476 bottles units

FDA Drug Class I Ongoing

Levetiracetam 0.75% in Sodium Chloride Injection 1,000 mg/100 mL (10 mg/mL), 1 x 100mL, Rx Only, Manufactured by: Gland Pharma Limited, Hyderabad, - 500 043 INDIA, Distributor: Dr. Reddy's Laboratorie

March 13, 2025 Dr. Reddy's Laboratories, Inc. 4,010 bags units

FDA Drug Class III Ongoing

Javygtor (sapropterin dihydrochloride) Tablets 100mg, 120-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 43598-096-04.

November 22, 2024 Dr. Reddy's Laboratories, Inc. 7,233 bottles units

FDA Drug Class III Ongoing

IBU (ibuprofen) 600 mg tablets, 500-count bottle, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-683-05

October 29, 2024 Dr. Reddy's Laboratories, Inc. 3416 botttles units

FDA Drug Class II Ongoing

Morphine Sulfate Extended-Release Tablets 30 mg, 100-count bottles, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-186-01.

October 22, 2024 Dr. Reddy's Laboratories, Inc. 532 100-count bottles units

FDA Drug Class II Ongoing

Morphine Sulfate Extended-Release Tablets 15 mg, 100-count per bottle, Rx Only, Manufactured by Mayne Pharma, Greenville, NC 27834, NDC 51862-185-01.

October 22, 2024 Dr. Reddy's Laboratories, Inc. 2,040 100-count bottles units

FDA Drug Class II Ongoing

Cinacalcet Tablets, 30 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-367-30.

October 9, 2024 Dr. Reddy's Laboratories, Inc. 285126 bottles units

FDA Drug Class II Ongoing

Cinacalcet Tablets, 60 mg, 30-count bottles, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India, NDC 43598-368-30.

October 9, 2024 Dr. Reddy's Laboratories, Inc. 35880 bottles units

FDA Drug Class II Ongoing

Cinacalcet Tablets, 90 mg, 30-count bottle, Rx Only, Dr. Reddy's Laboratories Inc, Princeton, NJ 08540, Made in India., NDC 43598-369-30.

October 9, 2024 Dr. Reddy's Laboratories, Inc. 10584 bottles units

FDA Drug Class II Ongoing

IBU Ibuprofen Tablets, USP, 600 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-683-01 - 100 Tablets per bottle, b)NDC 5511-683-05 - 500 Tablet

August 6, 2024 Dr. Reddy's Laboratories, Inc. 31,802 bottles units

FDA Drug Class II Ongoing

IBU Ibuprofen Tablets, USP, 400 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a) NDC 55111-682-01 - 100 Tablets per bottle, b) NDC 55111-682-05 - 500 Tab

August 6, 2024 Dr. Reddy's Laboratories, Inc. 14940 bottles units

FDA Drug Class II Ongoing

IBU Ibuprofen Tablets, USP, 800 mg, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, a)NDC 55111-684-01 - 100 Tablets per bottle, b)NDC 55111-684-05 - 500 Tabl

August 6, 2024 Dr. Reddy's Laboratories, Inc. 103,298 bottles units

FDA Drug Class III Ongoing

Sevelamer Carbonate for Oral Suspension 0.8g packets, packaged in 90 packets per container, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India NDC 43598-478-90

June 26, 2024 Dr. Reddy's Laboratories, Inc. 5,136 cartons units

FDA Drug Class II Terminated

Allopurinol Tablets, USP 300mg, 100 Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106 USA, NDC 55111-730-01.

June 7, 2024 Dr. Reddy's Laboratories, Inc. 20,520 units units

FDA Drug Class III Ongoing

Eszopiclone Tablets, USP 1mg CIV, 30-count bottle, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090 INDIA, NDC 55111-629-30

June 4, 2024 Dr. Reddy's Laboratories, Inc. 13,752 bottles units

FDA Drug Class II Ongoing

Zoledronic Acid Injection 5mg/100mL Sterile Solution, 100mL Single-Dose vials, Rx only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-688-52

May 23, 2024 Dr. Reddy's Laboratories, Inc. 13,880 vials units

FDA Drug Class III Ongoing

Sirolimus Tablets 1mg Tablets 100-count bottle, Rx Only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 55111-653-01

May 1, 2024 Dr. Reddy's Laboratories, Inc. 1,176 bottles units

FDA Drug Class I Ongoing

Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540 Made in India, NDC 435

April 8, 2024 Dr. Reddy's Laboratories, Inc. 17,332 cartons units

FDA Drug Class I Ongoing

Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual packets per carton, Rx Only, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC 43598-477-30.

April 8, 2024 Dr. Reddy's Laboratories, Inc. 2402 cartons units

FDA Drug Class III Ongoing

Glimepiride Tablets, USP 1mg, 100-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-01

January 18, 2024 Dr. Reddy's Laboratories, Inc. 59,336 bottles units

FDA Drug Class III Ongoing

Glimepiride Tablets, USP 1mg, 500-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Srikakulam-532 409 INDIA, NDC: 55111-320-05

January 18, 2024 Dr. Reddy's Laboratories, Inc. 14,425 bottles units

FDA Drug Class II Completed

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

January 2, 2024 Dr. Reddy's Laboratories, Inc. 38,952 bottles units

FDA Drug Class II Terminated

Tacrolimus Capsules, USP 1mg, 100-Count Bottles, Rx Only, Manufactured by: Dr. Reddy's Laboratories Limited, Bachupally, 500 090, INDIA, NDC 55111-526-01

December 15, 2023 Dr. Reddy's Laboratories, Inc. 8,280 bottles units

FDA Drug Class II Terminated

Montelukast Sodium Tablets, USP 10 mg, Rx Only, 1000 count bottle, Distributed by: Dr. Reddy's Laboratories., Princeton, NJ 08540, Made in India, NDC# 55111-725-10.

October 13, 2023 Dr. Reddy's Laboratories, Inc. 1,656 bottles units

FDA Drug Class II Ongoing

Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090, INDIA; NDC 55111-525-01.

February 8, 2023 Dr. Reddy's Laboratories, Inc. 4,320 bottles units

FDA Drug Class III Terminated

Allergy Relief D, Fexofenadine HCL 60mg/Antihistamine, Pseudoephedrine HCL 120mg/Nasal Decongestant, Extended-Release Tablets USP, packaged as (a) 20 count carton NDC 49032-273-20; (b) 30 count carton

November 21, 2022 Dr. Reddy's Laboratories, Inc. 25,176, 30-count; 22,968 20-count units

FDA Drug Class III Completed

Phytonadione Injectable Emulsion USP, 10 mg/mL, 25x 1 mL single dose ampules per carton, Rx only, Distributed by: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, NDC 43598-405-16

September 14, 2022 Dr. Reddy's Laboratories, Inc. 2,838 ampules units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08

July 13, 2022 Dr. Reddy's Laboratories, Inc. 2,639 cartons units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count blisters per carton, 10 Packs of 10 Tablets Each, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 08

July 13, 2022 Dr. Reddy's Laboratories, Inc. 2,892 cartons units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Orally Disintegrating Tablets, 30 mg, 10 Packs of 10 Tablets each, 100 Tablets per blister pack, Rx Only, Distributed by: Dr. Reddy's Laboratories, Inc., Princeton, NJ 085

April 15, 2022 Dr. Reddy's Laboratories, Inc. 252 Blister Packs units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Capsules, USP, 15 mg, a) 30-count bottle, (NDC 55111-398-30), b) 90-count bottle, (55111-398-90), Rx Only, Manufactured. By: Dr. Reddy's Laboratories Limited, Bachupally -

March 23, 2022 Dr. Reddy's Laboratories, Inc. 8,352 bottles (30-count), 1,368 bottles (90-count) units

FDA Drug Class II Terminated

Lansoprazole Delayed-Release Capsules, USP, 30 mg, 90-count bottle, Rx Only, Manufactured By: Dr. Reddy's Laboratories Limited, Bachupally - 500 090, India, NDC 55111-399-90.

March 23, 2022 Dr. Reddy's Laboratories, Inc. 7,703 bottles units

FDA Drug Class III Terminated

Atorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90

March 16, 2022 Dr. Reddy's Laboratories, Inc. 28,068 bottles units

FDA Drug Class III Terminated

Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, ND

February 17, 2022 Dr. Reddy's Laboratories, Inc. 340 packets units

FDA Drug Class III Terminated

Bortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60

January 19, 2022 Dr. Reddy's Laboratories, Inc. 2,980 vials units

FDA Drug Class III Terminated

Azacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62

January 19, 2022 Dr. Reddy's Laboratories, Inc. 18261 vials units

FDA Drug Class III Terminated

Azacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62

January 19, 2022 Dr. Reddy's Laboratories, Inc. 68061 vials units

FDA Drug Class III Terminated

Mucus Relief D, Guaifenesin Pseudoephedrine HCl ER Tablets, 600 mg/60mg, packaged in 36-count blister pack packed into cartons, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015, Made

January 10, 2022 Dr. Reddy's Laboratories, Inc. 18336 cartons units

FDA Drug Class III Terminated

Kroger, Allergy Relief-D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended-Release Tablets USP, 20 tablets per box, NDC 30142-611-14, Distributed by the Kroge

January 4, 2022 Dr. Reddy's Laboratories, Inc. 11,064 boxes units

FDA Drug Class III Terminated

Leader, 12HR Allergy & Congestion Relief, Fexofenadine HCl, 60mg Pseudoephedrine HCl 120mg Antihistamine Nasal Decongestant, 20 Extended Release Tablets per box, NDC 70000-0518-1, Distributed by Cardi

January 4, 2022 Dr. Reddy's Laboratories, Inc. 10,536 boxes units

FDA Drug Class III Terminated

Rite Aid Pharmacy, Allergy & Congestion, Fexofenadine HCl 60mg & Pseudoephedrine HCl 120mg, Extended Release Tablets USP, 20 Extended-Release Tablets per box, UPC 011822738873, Distributed by Rite Aid

January 4, 2022 Dr. Reddy's Laboratories, Inc. 7,080 boxes units

FDA Drug Class III Terminated

Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, U

January 4, 2022 Dr. Reddy's Laboratories, Inc. 9,912 boxes units

FDA Drug Class III Terminated

Wal-Fex D, Fexofenadine HCl 60mg/Antihistamine & Pseudoephedrine HCl 120mg/Nasal Decongestant, Extended Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 0363-1606-20, b) 30 Extended Re

January 4, 2022 Dr. Reddy's Laboratories, Inc. 67,848 boxes units

FDA Drug Class III Terminated

Rugby, Antihistamine and Nasal Decongestant, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets USP, 30 Tablets per box, NDC 0536-1242-07, Distributed by: Rugby Laboratories

January 4, 2022 Dr. Reddy's Laboratories, Inc. 2,352 boxes units

FDA Drug Class III Terminated

equate, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine, Pseudoephedrine HCl 120mg/Nasal Decongestant Extended-Release Tablets USP, a) 20 Extended Release Tablets per box, NDC 49035-273-20, b) 3

January 4, 2022 Dr. Reddy's Laboratories, Inc. 137,856 boxes units

FDA Drug Class III Terminated

CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablet

January 4, 2022 Dr. Reddy's Laboratories, Inc. 41,784 boxes units

FDA Drug Class III Terminated

QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157

January 4, 2022 Dr. Reddy's Laboratories, Inc. 9,984 boxes 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