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Lupin Pharmaceuticals Inc.: 122 FDA recall reports

Every drug recall the FDA has published for Lupin Pharmaceuticals Inc.. The fault, and how the agency graded it.

122Reports

5Class I

6Ongoing

2026-07-08Most recent

5 Class I on this page

Class I means the FDA judged there was a reasonable probability of serious harm or death. Check the lot numbers against anything you hold.

What the classes mean

The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.

Class	What the FDA is saying
Class I	There is a reasonable probability that using this will cause serious harm or death.
Class II	It may cause temporary or reversible harm. Serious harm is unlikely.
Class III	It breaks a rule but is unlikely to hurt anyone. Often a labelling fault.

Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.

By class

Class	Reports
Class II	77
Class III	40
Class I	5

By year reported

Year	Reports
2013	2
2014	4
2016	8
2017	4
2018	6
2019	25
2020	19
2021	11
2022	14
2023	5
2024	14
2025	7
2026	3

Checking whether it affects you

The lot or code number is what matters. Not the product name. A recall covers specific lots. Yours may not be one of them.

Check the code on your package against the report. The FDA keeps the current list at fda.gov/safety/recalls.

The reports

The text below is quoted from the FDA record word for word.

Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1

D-0723-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Product: Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-311-01
Where it went: Nationwide within the U.S.
How much: 64,894 units

prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (N

D-0655-2026 · Class II · reported 2026-07-08 · Ongoing

Why it was recalled: Presence of Foreign Substance
Product: prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-332-03), c) 15 mL (70748-332-04), Manufactured by: Lupin Limited, Pithampur (M.P) 454 775, INDIA
Where it went: U.S. Nationwide
How much: 2,530,182 bottles

Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, F

D-0541-2026 · Class II · reported 2026-05-27 · Ongoing

Why it was recalled: Presence of particulate matter: a white thread-like structure in the cartridge
Product: Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, Manufactured by: Lupin Limited, Nagpur 441108, INDIA, a) 2 Pens- NDC 70748-346-02; b) 3 Pens - NDC 70748-346-03.
Where it went: Nationwide within U.S
How much: 217,621 pen injectors

Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx

D-0220-2026 · Class II · reported 2025-12-17 · Ongoing

Why it was recalled: Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Product: 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, Manufactured by: Lupin Limited, Nagpur - 441108, INDIA, NDC 70748-274-01
Where it went: FL, MA, MI & OH
How much: 32736 vials

Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceutic

D-0227-2026 · Class II · reported 2025-12-17 · Ongoing

Why it was recalled: Defective container - seal not adhering to bottles
Product: Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.
Where it went: Nationwide.
How much: 52,128 bottles

Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin

D-0542-2025 · Class II · reported 2025-08-06 · Terminated

Why it was recalled: Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Product: 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, Goa 103 722, INDIA, NDC 68180-755-01.
Where it went: Nationwide in the US
How much: 7668 bottles

clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naple

D-0537-2025 · Class II · reported 2025-07-30 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Product: clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01
Where it went: Nationwide.
How much: 2,724 bottles

Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharma

D-0532-2025 · Class II · reported 2025-07-23 · Ongoing

Why it was recalled: Product Mix Up: This product is being recalled because of a complaint received that a sealed bottle of lisinopril and hydrochlorothiazide tablets 20mg/12.5 mg had a foreign tablet identified as atazanavir and ritonavir tablet 300mg/100mg.
Product: 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, NDC 68180-519-01
Where it went: Product was distributed nationwide within the United States.
How much: 58,968 bottles

clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuti

D-0377-2025 · Class II · reported 2025-04-30 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during 18-month long term stability study.
Product: 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, 441 108 INDIA, NDC 68180-492-01
Where it went: USA nationwide
How much: 2724 bottles

Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmace

D-0167-2025 · Class II · reported 2025-01-08 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Product: 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, Pithampur (M.P)- 454 775 INDIA, NDC# 68180-967-03
Where it went: One US distributor in Ohio.
How much: 480 1000-count bottles

Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and c) 500 count

D-0054-2025 · Class II · reported 2024-11-27 · Terminated

Why it was recalled: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Product: 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., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Where it went: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
How much: 357,414 bottles

Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and c) 500 count

D-0052-2025 · Class II · reported 2024-11-27 · Terminated

Why it was recalled: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Product: 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., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Where it went: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
How much: 112,770 bottles

Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c) 500 count (

D-0053-2025 · Class II · reported 2024-11-27 · Terminated

Why it was recalled: CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Product: 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., Baltimore, MD, Manufactured by Lupin Limited, Goa, India
Where it went: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide.
How much: 146,322 bottles

Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals,

D-0648-2024 · Class II · reported 2024-09-04 · Terminated

Why it was recalled: Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study.
Product: 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, NDC 68180-405-01
Where it went: USA nationwide.
How much: 4554 bottles

Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx only, Manufactu

D-0559-2024 · Class II · reported 2024-06-26 · Terminated

Why it was recalled: Failed Content Uniformity Specifications
Product: 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, Mandideep, India NDC 68180-407-03
Where it went: Nationwide in the US
How much: 3,552 bottles

Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured for: Lupin Ph

D-0518-2024 · Class II · reported 2024-06-05 · Terminated

Why it was recalled: Defective container: lack of seal integrity.
Product: 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, 462 046 India, NDC 68180-723-04
Where it went: USA Nationwide
How much: 51,006 bottles

Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured f

D-0496-2024 · Class II · reported 2024-05-22 · Terminated

Why it was recalled: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Product: 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: Lupin Limited, Mandideep 462 046, India, NDC 68180-723-04
Where it went: USA nationwide
How much: 17,070 bottles

Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, Manufactured f

D-0497-2024 · Class II · reported 2024-05-22 · Terminated

Why it was recalled: Presence of foreign substance: Product complaint of foreign material in reconstituted bottle.
Product: 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: Lupin Limited, Mandideep 462 046, India, NDC 68180-722-04
Where it went: USA nationwide
How much: 17,040 bottles

Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimo

D-0437-2024 · Class II · reported 2024-04-17 · Terminated

Why it was recalled: Subpotent Drug
Product: 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 6818-0659-06
Where it went: Nationwide within the United States
How much: 26,352 bottles

Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when reconstituted. Mixing Directions: Ta

D-0337-2024 · Class II · reported 2024-02-28 · Terminated

Why it was recalled: Labeling: Incorrect or Missing Package Insert
Product: 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 for 1 minute. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, MD 21202. NDC: 43386-038-60.
Where it went: OH, IL, NJ
How much: N/A

Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimo

D-0283-2024 · Class II · reported 2024-02-07 · Terminated

Why it was recalled: Subpotent Drug and Failed Impurities/Degradation Specifications
Product: 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, NDC 68180-658-06
Where it went: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
How much: 15,576 Bottles

Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc.,

D-0274-2024 · Class II · reported 2024-02-07 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications
Product: 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 68180-405-01
Where it went: Nationwide in the USA
How much: 4,608 Bottles

Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimor

D-0284-2024 · Class II · reported 2024-02-07 · Terminated

Why it was recalled: Subpotent Drug and Failed Impurities/Degradation Specifications
Product: 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 68180-659-06
Where it went: Product was distributed to 32 Wholesale/distributor accounts who further distributed the product to 156 distribution sites.
How much: 165,60 bottles

Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 count (NDC 68180-153-02) bottles, Rx

D-0221-2024 · Class II · reported 2024-01-17 · Terminated

Why it was recalled: CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the acceptable intake limit.
Product: 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.
Where it went: Product was distributed nationwide.
How much: 100=29,184 bottles; 500=2922 bottles

Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Bal

D-0148-2024 · Class II · reported 2023-12-20 · Terminated

Why it was recalled: Failed Dissolution Specifications
Product: 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
Where it went: Product was distributed to 3 wholesale/distributor accounts.
How much: N/A

Class I

Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefola

D-1081-2023 · Class I · reported 2023-08-09 · Terminated

Why it was recalled: Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test
Product: 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) further packaged in a carton of 3 blisters (NDC 68180-904-73), Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured by Lupin Limited, Pithampur (M.P.), INDIA
Where it went: USA nationwide.
How much: 4,179 boxes/_ cartons per box/3 pouches each/28 blister per pouch

Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals,

D-0899-2023 · Class III · reported 2023-07-19 · Terminated

Why it was recalled: Subpotent Drug: Out-of-Specification test results observed in assay test at 21-month long term stability study.
Product: 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 India, NDC 68180-721-03
Where it went: Product was distributed directly to three distributors in TN and NJ. Product may have been further distributed throughout the United States.
How much: 3,096 bottles

Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Balt

D-0174-2023 · Class III · reported 2023-02-01 · Terminated

Why it was recalled: Subpotent Drug: Low assay result observed during long-term stability testing.
Product: 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, NDC 68180-956-03
Where it went: USA Nationwide
How much: 5720 tubes

Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lupin Pharmaceuticals Baltimore, Ma

D-0100-2023 · Class II · reported 2023-01-18 · Terminated

Why it was recalled: Failed Impurities/Degradation Specifications: Failure observed in related substance testing during long term stability study.
Product: 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
Where it went: Distributed Nationwide in the USA
How much: 16,056 30 count bottles

Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Mary

D-0089-2023 · Class II · reported 2022-12-28 · Terminated

Why it was recalled: CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit.
Product: 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
Where it went: Product was distributed by major distribution chains nationwide.
How much: 23,736

Showing the 30 most recent of 122. The rest are searchable at the FDA enforcement report database.

Read these counts with three things in mind

A firm with more recalls usually makes more products. A contract packer runs hundreds of lines. It will out-recall a company with one product whatever either does. This is not a safety ranking.

Most recalls here are voluntary. A firm found its own fault and pulled the stock. That is the system working. It lands in this database looking the same as a recall the FDA had to push for.

Terminated means the FDA considers the recall finished. It is not a verdict. It does not mean anyone was harmed.

Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.

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