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.

76–100 of 123

  • LowFDA (Drugs)·D-0304-2020·2019-11-13

    Lupin Recalls Cephalexin Oral Suspension Due to Foreign Substance

    Lupin Pharmaceuticals is recalling Cephalexin for Oral Suspension bottles because a dead ant was identified as a foreign substance.

    Product
    Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1720-2019·2019-08-21

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Substance

    Lupin Pharmaceuticals is recalling specific bottles of Lisinopril and Hydrochlorothiazide tablets due to the presence of brownish or blackish stains and powder.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1565-2019·2019-08-07

    Lupin Recalls Kaitlib Fe Tablets Due to Stability Test Failures

    Lupin Pharmaceuticals is recalling Kaitlib Fe chewable tablets because long-term stability testing showed out-of-specification impurities or degradation.

    Product
    Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets (0.8 mg/0.025 mg) and Ferrous Fumarate, Chewable Tablets, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc. Baltimore, MD - 21202 Manufactured by: Lupin Limited Pathampur -454775 India. NDC 68180-903-11 (wallet o
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1581-2019·2019-07-31

    Lupin Recalls Lisinopril and Hydrochlorothiazide Tablets Due to Foreign Object

    Lupin Pharmaceuticals is recalling 11,832 bottles of Lisinopril and Hydrochlorothiazide tablets because a foreign tablet was found in the product.

    Product
    LISINOPRIL AND HYDROCHLOROTHIAZIDE — LISINOPRIL AND HYDROCHLOROTHIAZIDE (LISINOPRIL AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1518-2019·2019-07-31

    Lupin Recalls Nystatin and Triamcinolone Acetonide Cream for Stability Failure

    Lupin Pharmaceuticals is recalling Nystatin and Triamcinolone Acetonide Cream due to a failed uniformity of containers test. The recall covers 33,939 tubes distributed nationwide.

    Product
    NYSTATIN AND TRIAMCINOLONE ACETONIDE — NYSTATIN AND TRIAMCINOLONE ACETONIDE (NYSTATIN AND TRIAMCINOLONE ACETONIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1490-2019·2019-07-24

    Lupin Recalls Gatifloxacin Ophthalmic Solution Due to Missing Labels

    Lupin Pharmaceuticals is recalling 17,238 bottles of Gatifloxacin Ophthalmic Solution 0.5% because some bottles were found missing their labels.

    Product
    Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Sterile, 2.5 mL Bottle, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, India, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1121-2019·2019-04-17

    Lupin Recalls Telmisartan and Amlodipine Tablets Due to Stability Failures

    Lupin Pharmaceuticals is recalling 12,504 bottles of Telmisartan and Amlodipine tablets because they failed impurity and degradation specifications in a long-term stability study.

    Product
    TELMISARTAN AND AMLODIPINE — TELMISARTAN AND AMLODIPINE (TELMISARTAN AND AMLODIPINE)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-1057-2019·2019-04-03

    Lupin Recalls Fayosim Tablets Due to Impurity Test Failures

    Lupin Pharmaceuticals is recalling specific lots of Fayosim tablets because they failed impurity specifications during stability testing.

    Product
    Fayosim (levonorgestrel and ethinyl estradiol) tablets USP, (0.15 mg/0.02 mg, 0.15 mg/0.025 mg, 0.15 mg/0.03 mg) and ethinyl estradiol tablets USP, (0.01 mg), packaged in 1 Extended-Cycle Wallet of 91 Tablets packed in a pouch(NDC 68180-860-11); one pouch per carton (NDC 68180-86
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0517-2019·2019-03-06

    Lupin Recalls Moxifloxacin Ophthalmic Solution Due to Impurity Levels

    Lupin Pharmaceuticals is recalling Moxifloxacin Ophthalmic Solution because impurity levels exceeded specifications. The recall covers 674,628 bottles distributed nationwide and in Puerto Rico.

    Product
    MOXIFLOXACIN — MOXIFLOXACIN (MOXIFLOXACIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0513-2019·2019-02-27

    Lupin Recalls Lovastatin Tablets Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Lovastatin 40 mg tablets because the drug substance used was out of specification for impurity results.

    Product
    LOVASTATIN — LOVASTATIN (LOVASTATIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0429-2019·2019-02-13

    Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Failures

    Lupin Pharmaceuticals is recalling Bimatoprost Ophthalmic Solution 0.03% because out-of-specification results were observed for individual and total impurities.

    Product
    Bimatoprost Ophthalmic Solution 0.03%, packaged in a) 5 mL (NDC 68180-429-02) and b) 7.5 mL (NDC 68180-429-03) bottles, Rx only, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, INDIA.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0423-2019·2019-02-06

    Lupin Recalls Cephalexin Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling 14,400 bottles of Cephalexin for Oral Suspension due to CGMP deviations and the presence of extraneous material in sucrose excipients.

    Product
    CEPHALEXIN — CEPHALEXIN (CEPHALEXIN)
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0380-2019·2019-01-23

    Lupin Recalls Cephalexin Oral Suspension Due to Missing Manufacturing Records

    Lupin Pharmaceuticals is recalling 7,215 bottles of Cephalexin for Oral Suspension because the manufacturing batch record could not be located.

    Product
    Cephalexin for Oral Suspension USP, 250mg/5mL, 200 mL (when mixed), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland, Manufactured by: Lupin Limited, Mandideep, India ---- NDC 68180-0124-02
    Category
    Drug
    Distribution
    0 states
  • CriticalFDA (Drugs)·D-0358-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP due to the presence of grey rubber particulate matter in the vials.

    Product
    Ceftriaxone for Injection USP, 2 g, packaged in 10 Single Use Vials (NDC 68180-644-01) per box, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-644-10.
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0357-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP vials because grey rubber flecks were found in the reconstituted product.

    Product
    Ceftriaxone for Injection USP, 1 g, packaged in a) one Single Use Vial (NDC 68180-633-01) and b) 10 Single Use Vials per box (NDC 68180-633-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin Li
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0356-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 500 mg, due to the presence of grey rubber particulate matter from stoppers.

    Product
    Ceftriaxone for Injection USP, 500 mg, packaged in a) one Single Use Vial (NDC 68180-622-01) and b) 10 Single Use Vials per box (NDC 68180-622-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0355-2019·2019-01-16

    Lupin Recalls Ceftriaxone Injection Vials Due to Rubber Particulate Matter

    Lupin Pharmaceuticals is recalling Ceftriaxone for Injection USP, 250 mg, due to the presence of grey rubber particulate matter from stoppers in reconstituted vials.

    Product
    Ceftriaxone for Injection USP, 250 mg, packaged in a) one Single Use Vial (NDC 68180-611-01) and b) 10 Single Use Vials per box (NDC 68180-611-10); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., 111 South Calvert Street, Baltimore, Maryland 21202; Manufactured by: Lupin
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0375-2019·2019-01-16

    Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension because product complaints indicated the reconstituted suspension was observed to be thick.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0376-2019·2019-01-16

    Lupin Recalls Cefdinir Oral Suspension Due to CGMP Deviations

    Lupin Pharmaceuticals is recalling Cefdinir for Oral Suspension due to product complaints indicating the reconstituted suspension was observed to be thick.

    Product
    CEFDINIR — CEFDINIR (CEFDINIR)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0087-2019·2018-10-31

    Lupin Recalls Testosterone Topical Solution Due to Defective Pump

    Lupin Pharmaceuticals is recalling 6,752 bottles of Testosterone Topical Solution because the pump mechanism is not working.

    Product
    TESTOSTERONE — TESTOSTERONE (TESTOSTERONE)
    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.