Lupin Pharmaceuticals Inc.

FDA Drug Class II Ongoing

Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Man

November 13, 2025 Lupin Pharmaceuticals Inc. 32736 vials units

FDA Drug Class II Ongoing

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.

November 5, 2025 Lupin Pharmaceuticals Inc. 52,128 bottles units

FDA Drug Class II Ongoing

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL, 34108, United States, Manufactured by: Lupin Limited,

July 2, 2025 Lupin Pharmaceuticals Inc. 7668 bottles units

FDA Drug Class II Terminated

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01

June 27, 2025 Lupin Pharmaceuticals Inc. 2,724 bottles units

FDA Drug Class II Ongoing

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, Manufactured by: Lupin Limited Nagpur-441 108, INDIA,

June 20, 2025 Lupin Pharmaceuticals Inc. 58,968 bottles units

FDA Drug Class II Terminated

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lupin Limited, Nagpur, 44

April 10, 2025 Lupin Pharmaceuticals Inc. 2724 bottles units

FDA Drug Class II Terminated

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited, Pit

December 20, 2024 Lupin Pharmaceuticals Inc. 480 1000-count bottles units

FDA Drug Class II Terminated

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (NDC 68180-590-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimor

October 23, 2024 Lupin Pharmaceuticals Inc. 146,322 bottles units

FDA Drug Class II Terminated

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count (NDC 68180-589-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltim

October 23, 2024 Lupin Pharmaceuticals Inc. 112,770 bottles units

FDA Drug Class II Terminated

Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count (NDC 68180-591-02) bottles, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimo

October 23, 2024 Lupin Pharmaceuticals Inc. 357,414 bottles units

FDA Drug Class II Terminated

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA,

August 21, 2024 Lupin Pharmaceuticals Inc. 4554 bottles units

FDA Drug Class II Terminated

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore Maryland, Manufactured by: Lupin Limited,

May 30, 2024 Lupin Pharmaceuticals Inc. 3,552 bottles units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, Manufactured by: Lupin Limited, Mandideep, 462 0

May 8, 2024 Lupin Pharmaceuticals Inc. 51,006 bottles units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by

April 24, 2024 Lupin Pharmaceuticals Inc. 17,040 bottles units

FDA Drug Class II Terminated

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by

April 24, 2024 Lupin Pharmaceuticals Inc. 17,070 bottles units

FDA Drug Class II Terminated

Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India, NDC 6818-0659

March 21, 2024 Lupin Pharmaceuticals Inc. 26,352 bottles units

FDA Drug Class II Terminated

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Tap the bottle to release the powder. Add 50mL of water to the bottle and shake vigorously f

February 5, 2024 Lupin Pharmaceuticals Inc. N/A units

FDA Drug Class II Terminated

Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, NDC

January 5, 2024 Lupin Pharmaceuticals Inc. 165,60 bottles units

FDA Drug Class II Terminated

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured Lupin Limited, Aurangabad 431 210 INDIA, ND

January 5, 2024 Lupin Pharmaceuticals Inc. 15,576 Bottles units

FDA Drug Class II Terminated

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by:Lupin Limited, Mandideep 462 046 INDIA, NDC 681

January 3, 2024 Lupin Pharmaceuticals Inc. 4,608 Bottles units

FDA Drug Class II Terminated

Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202.

December 20, 2023 Lupin Pharmaceuticals Inc. 100=29,184 bottles; 500=2922 bottles units

FDA Drug Class II Terminated

Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 Manufactured by: Lupin Limited, Nagpur-441 108, India, NDC# 70748-153-01

November 22, 2023 Lupin Pharmaceuticals Inc. N/A units

FDA Drug Class III Terminated

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 U.S, Manufactured by: Lupin Limited, Aurangabad 431 210 Ind

June 27, 2023 Lupin Pharmaceuticals Inc. 3,096 bottles units

FDA Drug Class I Terminated

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg), packaged in 1 blister of 28 tablets each (NDC 68180-904-71)

June 23, 2023 Lupin Pharmaceuticals Inc. 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch units

FDA Drug Class III Terminated

Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, ND

January 20, 2023 Lupin Pharmaceuticals Inc. 5720 tubes units

FDA Drug Class II Terminated

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 210 India. NDC 68180-659-06

December 12, 2022 Lupin Pharmaceuticals Inc. 16,056 30 count bottles units

FDA Drug Class II Terminated

Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-554-09

December 7, 2022 Lupin Pharmaceuticals Inc. 30,612 bottles units

FDA Drug Class II Terminated

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, by: Lupin Limited, Goa 403 722 India, NDC# 68180-558-09

December 7, 2022 Lupin Pharmaceuticals Inc. 23,736 units

FDA Drug Class II Terminated

Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited, Nagpur- 441 108, India. NDC 68180-9

September 13, 2022 Lupin Pharmaceuticals Inc. 11,802 1000-count bottles units

FDA Drug Class II Terminated

Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06

July 28, 2022 Lupin Pharmaceuticals Inc. 7,872/30 count bottles units

FDA Drug Class II Terminated

Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16

June 10, 2022 Lupin Pharmaceuticals Inc. 3,216 bottles units

FDA Drug Class II Terminated

GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solution, USP with flavor pack NDC# 43386-060-19

April 27, 2022 Lupin Pharmaceuticals Inc. 26,910 bottles units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pitham

March 31, 2022 Lupin Pharmaceuticals Inc. 1,214,016 bottles units

FDA Drug Class II Terminated

Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Ph

March 31, 2022 Lupin Pharmaceuticals Inc. 657,336 bottles units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithamp

March 31, 2022 Lupin Pharmaceuticals Inc. 303,696 bottles units

FDA Drug Class II Terminated

Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pitha

March 31, 2022 Lupin Pharmaceuticals Inc. 2,361,924 bottles units

FDA Drug Class II Terminated

Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Ph

March 31, 2022 Lupin Pharmaceuticals Inc. 1,466,150 bottles units

FDA Drug Class II Terminated

Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin

March 31, 2022 Lupin Pharmaceuticals Inc. 1,247,067 bottles units

FDA Drug Class III Terminated

Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 0

December 29, 2021 Lupin Pharmaceuticals Inc. 23,965 100 count bottles units

FDA Drug Class III Terminated

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

December 22, 2021 Lupin Pharmaceuticals Inc. 50,832 bottles units

FDA Drug Class III Terminated

Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each,

November 19, 2021 Lupin Pharmaceuticals Inc. 4113 cartons units

FDA Drug Class III Terminated

Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.

October 20, 2021 Lupin Pharmaceuticals Inc. 16,272 bottles units

FDA Drug Class II Terminated

Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only

October 12, 2021 Lupin Pharmaceuticals Inc. 63,408 bottles units

FDA Drug Class II Terminated

Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count (NDC 68180-410-09) bottles, Rx only

October 12, 2021 Lupin Pharmaceuticals Inc. 51,144 bottles units

FDA Drug Class II Terminated

Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 count NDC# 68180-412-09) bottles, Rx only

October 12, 2021 Lupin Pharmaceuticals Inc. 119,544 bottles units

FDA Drug Class II Terminated

Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 count (NDC 68180-411-09) bottles, Rx only

October 12, 2021 Lupin Pharmaceuticals Inc. 134,016 bottles units

FDA Drug Class II Terminated

Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only

October 12, 2021 Lupin Pharmaceuticals Inc. 98,052 bottles units

FDA Drug Class II Terminated

Imipramine Pamoate Capsules 125 mg, 30-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 UNited States. Manufactured by: Lupin Limited, Pithampur, (M.P.) 45

October 8, 2021 Lupin Pharmaceuticals Inc. 1,902 bottles units

FDA Drug Class II Terminated

Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc. Baltimore, Maryland, 21202 United States, Manufactured by: Lupin Limited, Manddeep

April 29, 2021 Lupin Pharmaceuticals Inc. 3,138 bottles units

FDA Drug Class II Terminated

Cefprozil for Oral Suspension USP, 250mg/5mL, packaged as a) 50 mL (when mixed) bottles (NDC 68180-402-01); b) 75 mL (when mixed) bottles (NDC 68180-402-02); and c) 100 mL (when mixed) bottles (NDC 68

March 26, 2021 Lupin Pharmaceuticals Inc. a) 6,816 bottles; b) 3,960 bottles and c) 7,038 bottles units