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Lupin Pharmaceuticals Inc.

Recalls

Recalls by year

A bar chart of the number of recalls naming this company by year.

Recalls by year
YearRecalls
20182
201925
202019
202111
202214
20235
202414
20257
20263
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FDA Recall Ongoing 2026 recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing.
Published
July 8, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
Presence of Foreign Substance
Published
July 8, 2026
Distribution
Nationwide

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FDA Recall Ongoing 2026 recordClass II

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.

by Lupin Pharmaceuticals Inc.

Reason
Presence of particulate matter: a white thread-like structure in the cartridge
Published
May 27, 2026
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
Defective container - seal not adhering to bottles
Published
December 17, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity.
Published
December 17, 2025
Distribution
FL, MA, MI & OH

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FDA Recall Completed Historical recordClass II

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.

by Lupin Pharmaceuticals Inc.

Reason
Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027
Published
August 6, 2025
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry.
Published
July 30, 2025
Distribution
Nationwide

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FDA Recall Ongoing Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
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.
Published
July 23, 2025
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
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.
Published
April 30, 2025
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study.
Published
January 8, 2025
Distribution
One US distributor in Ohio.

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FDA Recall Terminated Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Published
November 27, 2024
Distribution
Nationwide

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FDA Recall Terminated Historical recordClass II

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

by Lupin Pharmaceuticals Inc.

Reason
CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor
Published
November 27, 2024
Distribution
Nationwide

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This page lists recalls that name Lupin Pharmaceuticals Inc. as the recalling firm in the official source notice. It is not a safety rating, ranking, or statement that the company acted negligently. Read the full medical disclaimer.