--- title: "Lupin Pharmaceuticals Inc. Recalls: Agency-Reported Status and History (Oct 1, 2026) | Is It on Recall" description: "Search Lupin Pharmaceuticals Inc. recall records, lots, firms and dates. Reported status can be incomplete; use the linked agency notice for current instructions." url: https://isitonrecall.com/brand/lupin-pharmaceuticals-inc/ updated: 2026-10-01 site: "Is It on Recall" language: en --- [Home](https://isitonrecall.com/) / Brand archive # Lupin Pharmaceuticals Inc. recall records **7** reported ongoing 54 records in this archive. Latest source date Aug 3, 2026. FDA enforcement status can lag behind the recall lifecycle. An empty search or a reported termination is not a personal product-safety determination. Archive changed Oct 1, 2026. USDA FSIS records are unavailable; [check FSIS directly](https://www.fsis.usda.gov/recalls). [Source coverage and dates](https://isitonrecall.com/sources/). ## Records and reported status Aug 3, 2026 FDA drug enforcement ### [Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, United States, Manufactured by: Lupin Limited, Pitha...](https://isitonrecall.com/recall/fda-drug-d-0789-2026-clobetasol-propionate-cream-usp-0-05-60-g-tube-rx-only-manufactured-for-lupin-pharmaceuticals-inc-na/) Failed content uniformity specifications. Class II Reported ongoing Distribution: USA Nationwide [Official source for Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceutica...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0789-2026%22) Jun 23, 2026 FDA drug enforcement ### [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.,...](https://isitonrecall.com/recall/fda-drug-d-0723-2026-glucagon-emergency-kit-for-low-blood-sugar-glucagon-for-injection-usp-1mg-per-vial-diluent-for-gluca/) CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. Class II Reported ongoing Distribution: Nationwide within the U.S. [Official source for Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0723-2026%22) Jun 4, 2026 FDA drug enforcement ### [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 L...](https://isitonrecall.com/recall/fda-drug-d-0655-2026-prednisolone-acetate-ophthalmic-suspension-usp-1-rx-only-sterile-a-5-ml-ndc-70748-332-02-b-10-ml-ndc/) Presence of Foreign Substance Class II Reported ongoing Distribution: U.S. Nationwide [Official source for prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02)...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0655-2026%22) Apr 24, 2026 FDA drug enforcement ### [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...](https://isitonrecall.com/recall/fda-drug-d-0541-2026-liraglutide-injection-18-mg-3-ml-6-mg-ml-rx-only-manufactured-for-lupin-pharmaceuticals-inc-naples-f/) Presence of particulate matter: a white thread-like structure in the cartridge Class II Reported ongoing Distribution: Nationwide within U.S [Official source for Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, In...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0541-2026%22) Nov 13, 2025 FDA drug enforcement ### [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 34...](https://isitonrecall.com/recall/fda-drug-d-0220-2026-ganirelix-acetate-injection-250-mcg-0-5ml-single-dose-sterile-prefilled-syringe-27-gauge-by-1-2-need/) Failed impurities/degradation specifications: out of specification results for Ganirelix acetate acrylic acid adduct impurity. Class II Reported ongoing Distribution: FL, MA, MI & OH [Official source for Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0220-2026%22) Nov 5, 2025 FDA drug enforcement ### [Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc., Naples, FL 34108, NDC 68180-353-09.](https://isitonrecall.com/recall/fda-drug-d-0227-2026-sertraline-hydrochloride-tablets-usp-100-mg-90-tablets-bottles-rx-only-manufactured-by-lupin-pharmac/) Defective container - seal not adhering to bottles Class II Reported ongoing Distribution: Nationwide. [Official source for Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0227-2026%22) Jul 2, 2025 FDA drug enforcement ### [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, Manufactu...](https://isitonrecall.com/recall/fda-drug-d-0542-2025-amlodipine-and-benazepril-hcl-capsules-usp-2-5-mg-10-mg-100-capsules-bottle-rx-only-manufactured-for/) Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expiry date as Feb.2027 instead of Jan.2027 Class II Reported terminated Distribution: Nationwide in the US [Official source for Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactur...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0542-2025%22) Jun 27, 2025 FDA drug enforcement ### [clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida 34108, NDC# 68180-492-01](https://isitonrecall.com/recall/fda-drug-d-0537-2025-clomipramine-hydrochloride-capsules-usp-25-mg-100-count-bottles-5801-pelican-bay-boulevard-suite-500/) Failed Impurities/Degradation Specifications: an out of specification result observed in degradation product test (any unspecified degradation product) during retention sample testing at expiry. Class II Reported terminated Distribution: Nationwide. [Official source for clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Sui...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0537-2025%22) Jun 20, 2025 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0532-2025-lisinopril-and-hydrochlorothiazide-tablets-usp-20mg-12-5mg-100-count-bottles-rx-only-mfg-for-lupin-p/) 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. Class II Reported ongoing Distribution: Product was distributed nationwide within the United States. [Official source for Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0532-2025%22) Apr 10, 2025 FDA drug enforcement ### [clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, United States, Manufactured By: Lu...](https://isitonrecall.com/recall/fda-drug-d-0377-2025-clomipramine-hydrochloride-capsules-usp-25-mg-100-count-bottle-rx-only-manufactured-for-lupin-pharma/) 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. Class II Reported terminated Distribution: USA nationwide [Official source for clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupi...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0377-2025%22) Dec 20, 2024 FDA drug enforcement ### [Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufactured...](https://isitonrecall.com/recall/fda-drug-d-0167-2025-levothyroxine-sodium-tablets-lupin-75-mcg-0-075mg-1000-tablets-rx-only-manufactured-for-lupin-pharma/) Failed Impurities/Degradation Specifications: Out of specifications result observed in the drug substance for impurity test during 3-month long term stability study. Class II Reported terminated Distribution: One US distributor in Ohio. [Official source for Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only, Manufactured for: L...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0167-2025%22) Oct 23, 2024 FDA drug enforcement ### [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 Pharma...](https://isitonrecall.com/recall/fda-drug-d-0052-2025-ramipril-capsules-usp-2-5-mg-a-90-count-ndc-68180-589-09-b-100-count-ndc-68180-589-01-and-c-500-coun/) CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Reported terminated Distribution: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. [Official source for Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count NDC 68180-589-01), and...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0052-2025%22) Oct 23, 2024 FDA drug enforcement ### [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 Pharmace...](https://isitonrecall.com/recall/fda-drug-d-0053-2025-ramipril-capsules-usp-5-mg-a-90-count-ndc-68180-590-09-b-100-count-ndc-68180-590-01-and-c-500-count/) CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Reported terminated Distribution: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. [Official source for Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC 68180-590-01), and c...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0053-2025%22) Oct 23, 2024 FDA drug enforcement ### [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 Pharmac...](https://isitonrecall.com/recall/fda-drug-d-0054-2025-ramipril-capsules-usp-10-mg-a-90-count-ndc-68180-591-09-b-100-count-ndc-68180-591-01-and-c-500-count/) CGMP Deviations: Active pharmaceutical ingredient was sourced from an unapproved vendor Class II Reported terminated Distribution: Product was distributed to 30 wholesalers/distributors who may have further distributed the product nationwide. [Official source for Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC 68180-591-01), and ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0054-2025%22) Aug 21, 2024 FDA drug enforcement ### [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, M...](https://isitonrecall.com/recall/fda-drug-d-0648-2024-cefixime-for-oral-suspension-usp-100-mg-5-ml-50-ml-bottle-rx-only-manufactured-for-lupin-pharmaceuti/) Subpotent Drug- An out of specification ( OOS ) result observed in assay test during 18-month long term stability study. Class II Reported terminated Distribution: USA nationwide. [Official source for Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufactured for: Lupin Pha...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0648-2024%22) May 30, 2024 FDA drug enforcement ### [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, Manufactu...](https://isitonrecall.com/recall/fda-drug-d-0559-2024-cefixime-for-oral-suspension-usp-200-mg-5-ml-50-ml-pack-size-powder-for-oral-suspension-rx-only-manu/) Failed Content Uniformity Specifications Class II Reported terminated Distribution: Nationwide in the US [Official source for Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for oral suspension, Rx on...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0559-2024%22) May 8, 2024 FDA drug enforcement ### [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 Li...](https://isitonrecall.com/recall/fda-drug-d-0518-2024-cefdinir-for-oral-suspension-usp-250-mg-5-ml-packaged-in-a-60-ml-bottle-rx-only-manufactured-for-lup/) Defective container: lack of seal integrity. Class II Reported terminated Distribution: USA Nationwide [Official source for Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx only, Manufactured ...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0518-2024%22) Apr 24, 2024 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0496-2024-cefdinir-for-oral-suspension-usp-250-mg-5-ml-60-ml-when-reconstituted-60-ml-bottle-rx-only-manufactu/) Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. Class II Reported terminated Distribution: USA nationwide [Official source for Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, M...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0496-2024%22) Apr 24, 2024 FDA drug enforcement ### [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 ...](https://isitonrecall.com/recall/fda-drug-d-0497-2024-cefdinir-for-oral-suspension-usp-125-mg-5-ml-60-ml-when-reconstituted-60-ml-bottle-rx-only-manufactu/) Presence of foreign substance: Product complaint of foreign material in reconstituted bottle. Class II Reported terminated Distribution: USA nationwide [Official source for Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 mL bottle, Rx only, M...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0497-2024%22) Mar 21, 2024 FDA drug enforcement ### [Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, Manufactured by: Lupin Limited Aurangabad 431 2...](https://isitonrecall.com/recall/fda-drug-d-0437-2024-rifampin-capsules-usp-300mg-30-count-bottles-rx-only-manufactured-for-lupin-pharmaceuticals-inc-balt/) Subpotent Drug Class II Reported terminated Distribution: Nationwide within the United States [Official source for Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lupin Pharmaceuticals,...](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0437-2024%22) ## Reasons in these listed records - Failed content uniformity specifications. - CGMP deviation: OOS result observed for the Gliding Force functionality test during 12-month long term stability testing. - Presence of Foreign Substance - Presence of particulate matter: a white thread-like structure in the cartridge These examples come from this result page and are not a ranking of every recall reason. ## Checking Lupin Pharmaceuticals Inc. ### Is there a recall on lupin pharmaceuticals inc. right now? This archive contains 54 records, including 7 with agency-reported ongoing status. The status field can be incomplete or stale. Open the current official notice and match your exact product. ### How do I check my package or product? Compare the product, firm and lot, date, model or serial identifiers with the notice. [Use the label-check guide](https://isitonrecall.com/guides/read-lot-codes/) if you need help locating an identifier. ### Does a matching name mean every item is included? A name is a search match. The agency notice sets the affected products and identifiers. Do not assume that every item with the same name or brand belongs to the recall. ### What if the search finds no matching record? This search has source and keyword limits. Missing records or a missing lot code do not establish that a product is unaffected. [Check source coverage](https://isitonrecall.com/sources/) and the agency's current notices. ### Where can I find older records? Use [monthly archives](https://isitonrecall.com/archives/) or the local search. The initial import covers records dated from October 2021 where available; each source's actual first and latest dates appear on the coverage page. ## Keep checking [Search Lupin Pharmaceuticals Inc.](https://isitonrecall.com/check/?q=Lupin%20Pharmaceuticals%20Inc.) [Browse related products](https://isitonrecall.com/products/) [Review source dates](https://isitonrecall.com/sources/)