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.

101–123 of 123

  • SevereFDA (Drugs)·D-1077-2018·2018-08-22

    Lupin Recalls Lisinopril Tablets Due to Metal Contaminant

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril tablets because a metal contaminant was found in one tablet.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1050-2018·2018-08-08

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Stability Test Failure

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because an out-of-specification result was found in a stability study. The product was distributed throughout the United States.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0838-2018·2018-05-30

    Lupin Recalls My Way Levonorgestrel Tablets for Lack of Approved NDA

    Lupin Pharmaceuticals is recalling My Way (levonorgestrel) emergency contraception tablets because the 2-pack configuration was marketed without an approved New Drug Application.

    Product
    My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD 21202; Manufactured by: Lupin Limited, Pithampur (M.P.) - 454 775, INDIA, UPC 3 68180 85212
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0837-2018·2018-05-30

    Lupin Recalls My Way Emergency Contraception Tablets for Lack of Approval

    Lupin Pharmaceuticals is recalling My Way emergency contraception tablets because the 2-pack configuration was marketed without the required regulatory approval.

    Product
    My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatments (Two 1.5mg Levonorgestrel Tablets) per carton, GAVIS Pharmaceuticals, A Lupin Group Company; Mfg. for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202, UPC 3 43386-622-31 3.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0684-2018·2018-04-25

    Lupin Recalls Cefdinir Powder for Oral Suspension Due to Superpotency

    Lupin Pharmaceuticals is voluntarily recalling 40,824 bottles of Cefdinir powder for oral suspension because the drug was found to be superpotent.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1127-2017·2017-09-13

    Lupin Recalls Famotidine Oral Suspension Due to Manufacturing Deviations

    Lupin Pharmaceuticals is recalling 12,888 bottles of Famotidine for Oral Suspension due to CGMP deviations. The FDA classified this voluntary recall as Class III.

    Product
    FAMOTIDINE — FAMOTIDINE (FAMOTIDINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0650-2017·2017-04-12

    Lupin Recalls Quinapril Tablets Due to Impurity A Specification Failure

    Lupin Pharmaceuticals is recalling Quinapril 5 mg tablets because they failed impurity specifications. The recall covers 15,168 bottles distributed nationwide.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1503-2016·2016-09-28

    Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 5,880 bottles of 40 mg Lisinopril tablets because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • LowFDA (Drugs)·D-1502-2016·2016-09-28

    Lupin Recalls Lisinopril Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 20,556 bottles of Lisinopril 30 mg tablets because they were manufactured using active pharmaceutical ingredients whose intermediates failed specifications.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1052-2016·2016-07-06

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling specific lots of Lisinopril and Hydrochlorothiazide tablets because they were manufactured using active ingredients that failed specifications.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0953-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection vials because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    Ceftriaxone for Injection USP, 1 g, Single Use Vial (NDC 68180-633-01) packaged in 10-count Vials per box (NDC 68180-633-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0954-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 570 vials of Ceftriaxone for Injection USP, 2 g, because the active pharmaceutical ingredients used in manufacturing failed specifications.

    Product
    Ceftriaxone for Injection USP, 2 g, Single Use Vial (NDC 68180-644-01) packaged in 10-count Vials per box (NDC 68180-644-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0951-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling specific lots of Ceftriaxone for Injection USP because they were manufactured using active pharmaceutical ingredients that failed specifications.

    Product
    Ceftriaxone for Injection USP, 250 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-611-01), and b) 10-count Vials per box (NDC 68180-611-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0955-2016·2016-06-08

    Lupin Recalls Ceftriaxone Sodium API Due to CGMP Deviations

    Lupin Pharmaceuticals Inc. is recalling Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient because intermediates failed specifications.

    Product
    Ceftriaxone Sodium (Sterile) USP active pharmaceutical ingredient, DMF No. 15931; Manufactured by: Lupin Limited, Unit-1, 198-202, New Industrial Area No. 2, Dist. Raisen, Mandideep-462 046, (Madhya Pradesh) India; Regd. Office: 159, CST Road Kalina, Santacruz (E), Mumbai- 400 09
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0952-2016·2016-06-08

    Lupin Recalls Ceftriaxone Injection Vials Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, because the active ingredients used in manufacturing failed specifications.

    Product
    Ceftriaxone for Injection USP, 500 mg, Single Use Vial, packaged in a) 1-count Vials per box (NDC 68180-622-01), and b) 10-count Vials per box (NDC 68180-622-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufact
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1187-2014·2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failure

    Lupin Pharmaceuticals is recalling specific lots of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

    Product
    Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1186-2014·2014-04-09

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 4,038 bottles of Suprax Cefixime for Oral Suspension because the product failed impurity specifications at the 9-month stability station.

    Product
    Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-408-2014·2014-01-22

    Lupin Recalls Quinapril Tablets Due to Unknown Impurity

    Lupin Pharmaceuticals is recalling Quinapril tablets because an unknown impurity exceeded specification limits during stability testing.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-346-2014·2013-12-18

    Lupin Recalls Ethambutol Hydrochloride Tablets Due to Impurity

    Lupin Pharmaceuticals is recalling 4,896 bottles of Ethambutol Hydrochloride 400 mg tablets because of an out-of-specification impurity result.

    Product
    ETHAMBUTOL HYDROCHLORIDE — ETHAMBUTOL HYDROCHLORIDE (ETHAMBUTOL HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-264-2013·2013-04-24

    Lupin Recalls Suprax Cefixime Oral Suspension Due to Discoloration

    Lupin Pharmaceuticals is recalling Suprax (cefixime) oral suspension bottles because the product may not meet color specifications after reconstitution.

    Product
    Suprax (cefixime for oral suspension) USP, 100 mg/5 mL, 50 mL bottles (when reconstituted), Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 68180-202-03.
    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.