Lupin Pharmaceuticals Inc.
Complete recall history across all FDA and CPSC categories, 119 total recalls
Lupin Pharmaceuticals Inc. appears in recall records across 1 category. This page consolidates all FDA food, drug, and medical device enforcement actions, plus CPSC consumer product recalls associated with this company. Recall data is sourced from openFDA and CPSC public databases.
Drug Recalls (119)
FDA drug safety enforcement actions by Lupin Pharmaceuticals Inc.. Showing most recent 50.
| Date | Product | Reason | Class |
|---|---|---|---|
| Jun 23, 2026 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg p... | CGMP deviation: OOS result observed for the Gliding Force functionality test ... | Class II |
| Jun 4, 2026 | prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 m... | Presence of Foreign Substance | Class II |
| Apr 24, 2026 | Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin... | Presence of particulate matter: a white thread-like structure in the cartridge | Class II |
| Nov 13, 2025 | Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syr... | Failed impurities/degradation specifications: out of specification results fo... | Class II |
| Nov 5, 2025 | Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Ma... | Defective container - seal not adhering to bottles | Class II |
| Jul 2, 2025 | Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle,... | Labeling: Incorrect or Missing Lot and/or Exp Date: released with wrong expir... | Class II |
| Jun 27, 2025 | clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelica... | Failed Impurities/Degradation Specifications: an out of specification result ... | Class II |
| Jun 20, 2025 | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles... | Product Mix Up: This product is being recalled because of a complaint receive... | Class II |
| Apr 10, 2025 | clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Ma... | Failed Impurities/Degradation Specifications: an out of specification result ... | Class II |
| Dec 20, 2024 | Levothyroxine Sodium Tablets, Lupin, 75 mcg (0.075mg), 1000 Tablets, Rx Only,... | Failed Impurities/Degradation Specifications: Out of specifications result ob... | Class II |
| Oct 23, 2024 | Ramipril Capsules USP 5 mg, a) 90 count (NDC 68180-590-09), b) 100 count NDC ... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unappro... | Class II |
| Oct 23, 2024 | Ramipril Capsules USP 2.5 mg, a) 90 count (NDC 68180-589-09), b) 100 count ND... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unappro... | Class II |
| Oct 23, 2024 | Ramipril Capsules USP 10 mg, a) 90 count (NDC 68180-591-09), b) 100 count NDC... | CGMP Deviations: Active pharmaceutical ingredient was sourced from an unappro... | Class II |
| Aug 21, 2024 | Cefixime for Oral Suspension USP, 100 mg/5 mL, 50 mL bottle, Rx only, Manufac... | Subpotent Drug- An out of specification ( OOS ) result observed in assay test... | Class II |
| May 30, 2024 | Cefixime for Oral Suspension USP 200 mg/5 mL (50 mL Pack size), Powder for or... | Failed Content Uniformity Specifications | Class II |
| May 8, 2024 | Cefdinir for Oral Suspension USP, 250 mg/5 mL, packaged in a 60 mL bottle, Rx... | Defective container: lack of seal integrity. | Class II |
| Apr 24, 2024 | Cefdinir for Oral Suspension USP 125 mg/5 mL (60 mL when reconstituted), 60 m... | Presence of foreign substance: Product complaint of foreign material in recon... | Class II |
| Apr 24, 2024 | Cefdinir for Oral Suspension USP 250 mg/5 mL (60 mL when reconstituted), 60 m... | Presence of foreign substance: Product complaint of foreign material in recon... | Class II |
| Mar 21, 2024 | Rifampin Capsules USP, 300mg, 30-count bottles, Rx only, Manufactured for: Lu... | Subpotent Drug | Class II |
| Feb 5, 2024 | Voriconazole for Oral Suspension, 40mg/mL, Orange-Flavored, 49g/75mL when rec... | Labeling: Incorrect or Missing Package Insert | Class II |
| Jan 5, 2024 | Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lup... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II |
| Jan 5, 2024 | Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lu... | Subpotent Drug and Failed Impurities/Degradation Specifications | Class II |
| Jan 3, 2024 | Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured f... | Failed Impurities/Degradation Specifications | Class II |
| Dec 20, 2023 | Desloratadine Tablets USP 5mg a) 100 count (NDC 68180-153-01) and b) 500 coun... | CGMP Deviations: N-Nitroso Desloratadine impurity result exceeded the accepta... | Class II |
| Nov 22, 2023 | Penicillamine Tablets USP 250 mg, 100-count bottle, Rx Only, Manufactured for... | Failed Dissolution Specifications | Class II |
| Jun 27, 2023 | Amlodipine Besylate Tablets, USP 10 mg, 1000-count bottles, Rx only, Manufact... | Subpotent Drug: Out-of-Specification test results observed in assay test at 2... | Class III |
| Jun 23, 2023 | Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 m... | Failed Stability Specification and Failed Impurities/Degradation Specificatio... | Class I |
| Jan 20, 2023 | Clobetasol propionate Cream USP, 0.05%, 45 g tube, Rx only, Manufactured for:... | Subpotent Drug: Low assay result observed during long-term stability testing. | Class III |
| Dec 12, 2022 | Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu... | Failed Impurities/Degradation Specifications: Failure observed in related sub... | Class II |
| Dec 7, 2022 | Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptab... | Class II |
| Dec 7, 2022 | Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptab... | Class II |
| Sep 13, 2022 | Lisinopril Tablets USP, 10 mg, 1000-count bottles, Rx Only, Manufactured for:... | Presence of Foreign Substance: Foreign material (metal piece) embedded in one... | Class II |
| Jul 28, 2022 | Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured ... | CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP... | Class II |
| Jun 10, 2022 | Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... | Failed Dissolution Specifications: Out of specification test results observed... | Class II |
| Apr 27, 2022 | GaviLyte -C (Polyethylene Glycol 3350, 240 g) and electrolytes for Oral Solut... | Failed Stability Specification | Class II |
| Mar 31, 2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Mar 31, 2022 | Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Mar 31, 2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-c... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Mar 31, 2022 | Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Mar 31, 2022 | Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Mar 31, 2022 | Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-... | CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits | Class II |
| Dec 29, 2021 | Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, ... | Out-of-specification impurity test result observed at 18-month long term stab... | Class III |
| Dec 22, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a w... | Class III |
| Nov 19, 2021 | Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... | Subpotent Drug | Class III |
| Oct 20, 2021 | Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... | Failed Stability Specifications: Out-of-specification results observed in a w... | Class III |
| Oct 12, 2021 | Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II |
| Oct 12, 2021 | Irbesartan Tablets USP, 75 mg a) 30 count (NDC 68180-410-06) and b) 90 count... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II |
| Oct 12, 2021 | Irbesartan Tablets USP, 300 mg a) 30 count (NDC 68180-412-06) and b) 90 coun... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II |
| Oct 12, 2021 | Irbesartan Tablets USP, 150 mg a) 30 count (NDC 68180-411-06) and b) 90 coun... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II |
| Oct 12, 2021 | Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC... | CGMP Deviations: impurity N-nitrosoirbesartan detected in API | Class II |
Frequently Asked Questions
A high number of recalls does not necessarily indicate that a company is unsafe. Large manufacturers that produce thousands of products across multiple categories will statistically appear in recall databases more frequently. What matters more is the severity of each recall (Class I being the most serious), the speed of response, and whether the company proactively identified and addressed the issue. Companies with robust safety programs often catch problems earlier.
Food, drug, and medical device recall data comes from the FDA's openFDA enforcement database, which contains all FDA enforcement reports. Consumer product recall data comes from the U.S. Consumer Product Safety Commission (CPSC). Both sources are public government databases that are updated regularly. RecallCheck aggregates these sources to provide a unified view of a company's recall history.
The FDA classifies recalls into three categories. Class I is the most serious, there is a reasonable probability that use of or exposure to the product will cause serious adverse health consequences or death. Class II means the product may cause temporary or medically reversible health problems, or the probability of serious consequences is remote. Class III is the least serious, the product is unlikely to cause adverse health consequences. CPSC product recalls do not use this classification system.
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