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.

51–75 of 123

  • ModerateFDA (Drugs)·D-0091-2022·2021-11-03

    Gatifloxacin Ophthalmic Solution Recalled for Failed Stability Tests

    Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to failed water loss tests that may affect drug concentration. The recall affects 16,272 bottles distributed nationwide.

    Product
    Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0027-2022·2021-10-27

    Lupin Imipramine Pamoate Capsules Recalled for Failed Dissolution Test

    Lupin Pharmaceuticals is recalling approximately 1,902 bottles of Imipramine Pamoate Capsules 125 mg due to out-of-specification results in dissolution testing at the 9-month stability checkpoint.

    Product
    IMIPRAMINE PAMOATE — IMIPRAMINE PAMOATE (IMIPRAMINE PAMOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0390-2021·2021-05-26

    Lupin Recalls Subpotent Cefixime Oral Suspension Bottles Nationwide

    Lupin Pharmaceuticals is voluntarily recalling 3,138 bottles of Cefixime for Oral Suspension because the drug is subpotent. The affected product was distributed nationwide in the United States.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0332-2021·2021-04-21

    Lupin Recalls Cefprozil Oral Suspension Due to Superpotent Drug Concerns

    Lupin Pharmaceuticals is recalling specific lots of Cefprozil for Oral Suspension because the drug may be superpotent. The recall covers bottles distributed nationwide in the USA and Puerto Rico.

    Product
    CEFPROZIL — CEFPROZIL (CEFPROZIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0247-2021·2021-02-10

    Lupin Recalls Oseltamivir Phosphate Oral Suspension Due to Impurity Issues

    Lupin Pharmaceuticals is recalling 46,479 bottles of Oseltamivir Phosphate oral suspension because out-of-specification test results were found for Impurity C during stability testing.

    Product
    OSELTAMIVIR PHOSPHATE — OSELTAMIVIR PHOSPHATE (OSELTAMIVIR PHOSPHATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1502-2020·2020-08-19

    Lupin Recalls Mibelas 24 Fe Tablets Due to Impurity Test Failures

    Lupin Pharmaceuticals is recalling Mibelas 24 Fe chewable tablets because they failed impurity specifications. The recall covers 560,922 pouches distributed nationwide.

    Product
    Mibelas 24 Fe (norethindrone acetate and ethinyl estradiol tablets and ferrous fumarate tablets) chewable,1 mg/0.02 mg/75 mg, Rx Only, Provides 24 days of active therapy, Pouch Contains one wallet of 28 tablets, NDC: 68180-911-11, Carton contains 3 wallets of 28 tablets each, NDC
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1413-2020·2020-08-05

    Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Presence

    Lupin Pharmaceuticals is recalling specific bottles of 10 mg Lisinopril tablets because 20 mg tablets were found inside. Consumers should stop using the affected product.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    1 state
  • SevereFDA (Drugs)·D-1383-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1385-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1382-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-release Tablets because FDA analysis detected NDMA impurity above acceptable intake levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1384-2020·2020-07-22

    Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake level.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1334-2020·2020-07-01

    Lupin Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity

    Lupin Pharmaceuticals is recalling 6,540 bottles of Metformin Hydrochloride Extended-Release Tablets because FDA analysis detected N-Nitrosodimethylamine (NDMA) above acceptable levels.

    Product
    METFORMIN HYDROCHLORIDE — METFORMIN HYDROCHLORIDE (METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    0 states
  • HighFDA (Drugs)·D-1290-2020·2020-06-17

    Lupin Recalls Lisinopril 5 mg Tablets Due to Product Mix-Up

    Lupin Pharmaceuticals is recalling 4,224 bottles of Lisinopril 5 mg tablets because 10 mg tablets were found in the bottles.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1252-2020·2020-04-29

    Lupin Recalls Cefixime Oral Suspension Due to Low Potency

    Lupin Pharmaceuticals is recalling 4,518 bottles of Cefixime for Oral Suspension because a stability study showed the drug was below the required strength.

    Product
    CEFIXIME — CEFIXIME (CEFIXIME)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1250-2020·2020-04-29

    Lupin Recalls 20 mg Lisinopril Tablets Due to Product Mix-Up

    Lupin Pharmaceuticals is recalling 20 mg Lisinopril tablets because 10 mg tablets were found inside sealed 20 mg bottles.

    Product
    Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1079-2020·2020-04-08

    Lupin Recalls Lisinopril Tablets Due to Foreign Tablet Mix-Up

    Lupin Pharmaceuticals is recalling 25,944 bottles of Lisinopril 30 mg tablets because a 5 mg tablet was found mixed into a 30 mg bottle.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1056-2020·2020-03-18

    Lupin Recalls Levonorgestrel and Ethinyl Estradiol Tablets for Content Uniformity

    Lupin Pharmaceuticals is recalling specific lots of oral contraceptive tablets due to failed content uniformity tests.

    Product
    Levonorgestrel and Ethinyl Estradiol Tablets USP, 0.05mg/0.03 mg, 0.075mg/0.04mg, and 0.125mg/0.03mg, packaged in 1 Wallet of 28 Tablets (NDC 68180-857-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-857-13); Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-1055-2020·2020-03-18

    Lupin Recalls Bekyree Tablets Due to Content Uniformity Failures

    Lupin Pharmaceuticals is recalling specific lots of Bekyree oral contraceptives because they failed content and blend uniformity tests.

    Product
    Bekyree (desogestrel and ethinyl estradiol tablets USP, 0.15 mg/0.02 mg and ethinyl estradiol tablets USP, 0.01 mg), packaged in 1 Wallet of 28 Tablets (NDC 68180-879-11), 3 Wallets of 28 Tablets Each per carton (NDC 68180-879-13), Rx Only, Distributed by: Lupin Pharmaceuticals,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0866-2020·2020-03-11

    Lupin Recalls Desoximetasone Topical Spray Due to Impurity Failures

    Lupin Pharmaceuticals is recalling 876 bottles of Desoximetasone Topical Spray because high out-of-specification impurities were detected.

    Product
    Desoximetasone Topical Spray, 0.25%, 2.5 mg desoximetasone, 100 mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals, Baltimore, MD
    Category
    Drug
    Distribution
    0 states
  • ModerateFDA (Drugs)·D-0855-2020·2020-02-19

    Lupin Recalls Memantine Hydrochloride Capsules for Dissolution Failure

    Lupin Pharmaceuticals is recalling 6,294 bottles of Memantine Hydrochloride Extended Release Capsules because they failed to meet dissolution specifications during stability testing.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0790-2020·2020-01-22

    Lupin Recalls Tri-Lo-Marzia Tablets Due to Blend Uniformity Deviations

    Lupin Pharmaceuticals is recalling specific lots of Tri-Lo-Marzia oral contraceptives due to out-of-specification test results found during a retrospective review of blend uniformity data.

    Product
    Tri-Lo-Marzia (Norgestimate and Ethinyl Estradiol Tablets, USP), 0.180 mg/0.025 mg; 0.215mg/0.025 mg and 0.250 mg/0.025 mg, Pack size - 3 x 28's wallets/carton, Rx Only, Distributed by Lupin Pharmaceuticals, Inc, Baltimore MD 21202, Manufactured by: Lupin Limited, Pithampur, (M.P
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0638-2020·2020-01-15

    Lupin Recalls Blisovi Fe 1.5/30 Tablets Due to Crumbling

    Lupin Pharmaceuticals is recalling Blisovi Fe 1.5/30 tablets because they crumble when removed from the blister pack.

    Product
    Blisovi Fe 1.5/30 (norethindrone acetate and ethinyl estradiol tablets USP and ferrous fumarate tablets 75mg), Rx Only, Distributed by: Lupin Pharmaceuticals Inc Baltimore, MD 21202, Manufactured for: Lupin Limited Pithampur 454775 INDIA 240875, NDC 68180-866-11
    Category
    Drug
    Distribution
    Distributed nationwide
  • LowFDA (Drugs)·D-0635-2020·2020-01-08

    Lupin Recalls Bimatoprost Ophthalmic Solution Due to Impurity Specifications

    Lupin Pharmaceuticals is recalling 2,130 bottles of Bimatoprost Ophthalmic Solution because an out-of-specification impurity was detected.

    Product
    Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0629-2020·2019-12-25

    Lupin Recalls Memantine Hydrochloride Capsules Due to Dissolution Failure

    Lupin Pharmaceuticals is recalling 3,726 bottles of Memantine Hydrochloride Extended-release Capsules because stability studies showed high out-of-specification dissolution results.

    Product
    MEMANTINE HYDROCHLORIDE — MEMANTINE HYDROCHLORIDE (MEMANTINE HYDROCHLORIDE)
    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.