The Recall Desk

Manufacturer

Lupin Pharmaceuticals Inc.

123 recalls in our database name Lupin Pharmaceuticals Inc. as the manufacturing or recalling firm.

What the numbers show

Total
123
Critical
1
Severe
20
Most recent
2026-09-02

Of the 123 recalls from Lupin Pharmaceuticals Inc. we have scored against our rubric, 1 (1%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 20 (16%) are Severe.

About this listing

The manufacturer string comes from the agency’s own source notice — for FDA recalls, the “recalling firm” field; for NHTSA recalls, the vehicle manufacturer; for CPSC recalls, the firm-of-record on the joint press release. A single corporate family can appear under multiple manufacturer strings as agency notices aren’t standardized on a canonical name. If you don’t see recalls you expect, try a parent-company search or a broader full-text search.

Severity scores below are computed from the agency’s classification and the recall text, never from manufacturer behaviour or history. Many manufacturers issue routine corrective actions (software updates, labelling corrections) that are correctly scored low — having recalls on this list isn’t inherently a quality signal.

1–25 of 123

  • ModerateFDA (Drugs)·D-0789-2026·2026-09-02

    Lupin Recalls Clobetasol Propionate Cream for Content Uniformity Failures

    Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% because it failed content uniformity specifications. The recall covers 5,082 tubes distributed nationwide.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0723-2026·2026-07-08

    Glucagon Emergency Kit Recalled for Manufacturing Process Deviation

    Lupin Pharmaceuticals is recalling Glucagon Emergency Kits (1mg) nationwide due to a manufacturing process deviation found during stability testing. The gliding force functionality test failed to meet specifications during 12-month testing.

    Product
    GLUCAGON — GLUCAGON (GLUCAGON)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0655-2026·2026-07-08

    Prednisolone Acetate Ophthalmic Suspension Recalled for Foreign Substance

    Lupin Pharmaceuticals is recalling Prednisolone Acetate Ophthalmic Suspension, USP, 1% due to the presence of a foreign substance. Affected lot numbers were distributed nationwide.

    Product
    PREDNISOLONE ACETATE — PREDNISOLONE ACETATE (PREDNISOLONE ACETATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0541-2026·2026-05-27

    Liraglutide Injection Recalled Due to Particulate Matter in Cartridges

    Lupin Pharmaceuticals is recalling Liraglutide Injection due to the presence of white thread-like structures (particulate matter) found in cartridges. The recall affects 217,621 pen injectors distributed nationwide.

    Product
    LIRAGLUTIDE — LIRAGLUTIDE (LIRAGLUTIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0220-2026·2025-12-17

    Ganirelix acetate injection recalled after failing an impurity specification

    Lupin Pharmaceuticals is recalling 32,736 units of Ganirelix Acetate Injection after out of specification results for the ganirelix acetate acrylic acid adduct impurity.

    Product
    GANIRELIX ACETATE — GANIRELIX ACETATE (GANIRELIX ACETATE)
    Category
    Drug
    Distribution
    4 states
  • ModerateFDA (Drugs)·D-0227-2026·2025-12-17

    Sertraline tablets recalled because bottle seals are not adhering

    Lupin Pharmaceuticals is recalling 52,128 bottles of Sertraline Hydrochloride Tablets, 100 mg, over a defective container in which the seal is not adhering to the bottles.

    Product
    SERTRALINE HYDROCHLORIDE — SERTRALINE HYDROCHLORIDE (SERTRALINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0542-2025·2025-08-06

    Amlodipine and benazepril capsules released with the wrong expiry date

    Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg are being recalled because they were released with the wrong expiry date, printed as February 2027 instead of January 2027. 7,668 bottles affected.

    Product
    AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE — AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE (AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0537-2025·2025-07-30

    Clomipramine capsules failed a degradation product specification at expiry testing

    Clomipramine Hydrochloride Capsules USP 25 mg are being recalled after an out of specification result for an unspecified degradation product during retention sample testing at expiry. 2,724 bottles affected.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0532-2025·2025-07-23

    Lisinopril and hydrochlorothiazide bottle contained a foreign antiretroviral tablet

    Lisinopril and Hydrochlorothiazide Tablets 20 mg/12.5 mg are being recalled after a complaint that a sealed bottle contained a foreign tablet identified as atazanavir and ritonavir. 58,968 bottles affected.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0377-2025·2025-04-30

    Clomipramine Hydrochloride Capsules recalled for degradation product specification failure

    Lupin Pharmaceuticals is recalling Clomipramine Hydrochloride Capsules (25 mg) due to an unspecified degradation product detected in stability testing. The defect was identified during an 18-month long-term stability study.

    Product
    CLOMIPRAMINE HYDROCHLORIDE — CLOMIPRAMINE HYDROCHLORIDE (CLOMIPRAMINE HYDROCHLORIDE CAPSULES)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0167-2025·2025-01-08

    Levothyroxine Sodium tablets recalled for impurity specification failure

    Lupin Pharmaceuticals is recalling Levothyroxine Sodium 75 mcg tablets due to out-of-specification impurities detected in stability testing. Affected lot LA01276 (expiring 07/2026) was distributed to one Ohio distributor.

    Product
    LEVOTHYROXINE SODIUM — LEVOTHYROXINE SODIUM (LEVOTHYROXINE SODIUM)
    Category
    Drug
    Distribution
    1 state
  • HighFDA (Drugs)·D-0053-2025·2024-11-27

    Prescription Drug Recall: Ramipril Capsules from Unapproved Supplier

    Lupin Pharmaceuticals is recalling certain lots of Ramipril 5 mg capsules because the active ingredient was sourced from an unapproved vendor, raising concerns about product quality and safety.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0054-2025·2024-11-27

    Ramipril Capsule Medication Recalled Over Unapproved Vendor Manufacturing Deviations

    Lupin Pharmaceuticals is recalling 357,414 bottles of Ramipril 10 mg capsules due to CGMP deviations where the active pharmaceutical ingredient was sourced from an unapproved vendor. The affected product was distributed to 30 wholesalers with potential nationwide distribution.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0052-2025·2024-11-27

    FDA recalls Ramipril 2.5 mg capsules for manufacturing control deviations

    Lupin Pharmaceuticals is recalling Ramipril 2.5 mg capsules after sourcing the active ingredient from an unapproved vendor. Approximately 112,770 bottles were distributed to wholesalers nationwide.

    Product
    RAMIPRIL — RAMIPRIL (RAMIPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0648-2024·2024-09-04

    Cefixime oral suspension antibiotic recalled nationwide for subpotency

    Lupin Pharmaceuticals is recalling Cefixime 100 mg/5 mL oral suspension due to subpotency discovered during stability testing. The affected lot (F201517) was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0559-2024·2024-06-26

    Cefixime Oral Suspension Recalled for Failed Content Uniformity Specifications

    Lupin Pharmaceuticals is recalling one lot of Cefixime oral suspension (200 mg/5 mL) due to failed content uniformity specifications. The recall affects 3,552 bottles distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0518-2024·2024-06-05

    Cefdinir Oral Suspension recalled nationwide for defective container seals

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to defective container seals. The recall affects 51,006 bottles distributed nationwide with lot numbers F305184, F305185, and F305186.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0497-2024·2024-05-22

    Antibiotic Cefdinir Oral Suspension Recalled Over Foreign Material

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to foreign material found in reconstituted bottles. This FDA Class II recall affects 17,040 bottles distributed nationwide.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0496-2024·2024-05-22

    Antibiotic Cefdinir Oral Suspension Recalled for Foreign Material Contamination

    Lupin Pharmaceuticals is recalling Cefdinir Oral Suspension USP 250 mg/5 mL (Lot F305442, expiration 8/30/2025) due to foreign material found in reconstituted bottles. Approximately 17,070 bottles were distributed nationwide.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0437-2024·2024-04-17

    FDA Recalls Rifampin Capsules 300mg Nationwide for Subpotency

    Lupin Pharmaceuticals recalls Rifampin Capsules USP 300mg nationwide due to subpotency—the drug contains less active ingredient than labeled. Affected lot: A201064, expiring March 2024. 26,352 bottles involved.

    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
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0337-2024·2024-02-28

    Voriconazole Oral Suspension Recalled for Missing Package Insert

    Lupin Pharmaceuticals recalls Voriconazole for Oral Suspension (40mg/mL) due to missing or incorrect package inserts on affected batches distributed in Ohio, Illinois, and New Jersey.

    Product
    VORICONAZOLE — VORICONAZOLE (VORICONAZOLE)
    Category
    Drug
    Distribution
    3 states
  • HighFDA (Drugs)·D-0283-2024·2024-02-07

    Antibiotic Rifampin Capsules Recalled for Subpotency and Quality Failures

    Lupin Pharmaceuticals recalled 15,576 bottles of Rifampin antibiotic capsules due to subpotency and failed quality specifications. The affected lots did not meet pharmaceutical standards for drug strength and purity.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0284-2024·2024-02-07

    Rifampin Antibiotic Capsules Recalled for Subpotency and Failed Specifications

    Lupin Pharmaceuticals recalls Rifampin 300mg capsules (lot A200817, exp 1/2024) due to subpotency and failed impurities/degradation specifications. Patients should consult their doctor before stopping medication.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-0274-2024·2024-02-07

    Lupin Pharmaceuticals Recalls Cefixime Suspension Over Failed Specifications

    Lupin Pharmaceuticals is recalling Cefixime for Oral Suspension 100mg/5mL (4,608 bottles) due to failed impurity and degradation specifications. The product was distributed nationwide.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0221-2024·2024-01-17

    FDA Recalls Desloratadine Tablets Due to Manufacturing Defect

    Lupin Pharmaceuticals is recalling Desloratadine 5mg tablets distributed nationwide because N-Nitroso impurity levels exceeded acceptable limits. Affected lots expire in January 2024.

    Product
    DESLORATADINE — DESLORATADINE (DESLORATADINE)
    Category
    Drug
    Distribution
    Distributed nationwide

About this company

Community-sourced company facts from Wikidata, not from any recall agency. This is background on the corporate entity — it says nothing about the recall(s) listed on this page, which come from the agency source notice above.

Lupin Pharmaceuticals (United States)

company in Baltimore, United States

Country
United States
Founded
1968

Official website

Source: Wikidata (Q55454567), licensed CC0. Wikidata is community-edited and may not reflect the current corporate structure.