The Recall Desk

Manufacturer

Lupin Pharmaceuticals Inc.

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

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.

26–50 of 52

  • HighFDA (Drugs)·D-0148-2024·2023-12-20

    Penicillamine Tablets Recalled Due to Failed Dissolution Specifications

    Lupin Pharmaceuticals is recalling Penicillamine Tablets USP 250 mg (Lot M200498) due to failed dissolution specifications. The affected tablets may not dissolve as intended, potentially affecting drug performance.

    Product
    PENICILLAMINE — PENICILLAMINE (PENICILLAMINE)
    Category
    Drug
    Distribution
    0 states
  • SevereFDA (Drugs)·D-1081-2023·2023-08-09

    Prescription Birth Control Tablets Recalled for Failed Stability Testing

    Lupin Pharmaceuticals is recalling TYDEMY birth control tablets due to failed stability testing. Consumers should contact their healthcare provider.

    Product
    TYDEMY — TYDEMY (DROSPIRENONE, ETHINYL ESTRADIOL AND LEVOMEFOLATE CALCIUM AND LEVOMEFOLATE CALCIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0899-2023·2023-07-19

    Amlodipine Besylate 10 mg Tablets Recalled for Failing Potency Tests

    Lupin Pharmaceuticals recalls Amlodipine Besylate 10 mg tablets (Lot A102887) after stability testing revealed the tablets failed potency specifications, containing less active ingredient than labeled. Patients should contact their pharmacist or doctor.

    Product
    AMLODIPINE BESYLATE — AMLODIPINE BESYLATE (AMLODIPINE BESYLATE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0174-2023·2023-02-01

    Clobetasol Propionate Cream recalled due to subpotent drug

    Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% nationwide because stability testing revealed insufficient active ingredient in the affected lot.

    Product
    CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0100-2023·2023-01-18

    Prescription Rifampin Capsules Recalled for Failed Impurity Specifications

    Lupin Pharmaceuticals is recalling Rifampin Capsules (300 mg) nationwide due to failed impurity and degradation specifications found during stability testing. Lot A200171 (exp. 12/2023) is affected, with over 16,000 bottles distributed.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0088-2023·2022-12-28

    Prescription Drug Quinapril Recalled for Chemical Impurity Exceeding Safety Limits

    Lupin Pharmaceuticals is recalling Quinapril 40mg tablets due to detection of N-Nitroso-quinapril impurity above acceptable daily intake limits. The recall affects approximately 30,612 bottles distributed nationwide.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0089-2023·2022-12-28

    Quinapril Tablets Recalled Due to Excess Impurity Above Limits

    Lupin Pharmaceuticals is recalling Quinapril tablets (20 mg) due to N-nitroso-quinapril impurity detected above acceptable daily intake limits. The recall affects approximately 23,736 units distributed nationwide.

    Product
    QUINAPRIL — QUINAPRIL (QUINAPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1536-2022·2022-09-21

    Lisinopril Tablets Recalled for Embedded Metal Contamination

    Lupin Pharmaceuticals is recalling Lisinopril 10 mg tablets due to discovery of a metal piece embedded in one tablet. Affected lot Q201182 was distributed nationwide to wholesalers.

    Product
    LISINOPRIL — LISINOPRIL (LISINOPRIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1343-2022·2022-08-24

    Rifampin Capsules Recalled Due to Manufacturing Control Deviation

    Lupin Pharmaceuticals is recalling Rifampin 150 mg capsules (lot #A200170) nationwide due to a Current Good Manufacturing Practice deviation with an out-of-specification impurity detected during manufacturing.

    Product
    RIFAMPIN — RIFAMPIN (RIFAMPIN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1150-2022·2022-06-22

    Zileuton Extended-Release Tablets recalled for failed dissolution specifications

    Lupin Pharmaceuticals is recalling Zileuton Extended-Release Tablets, 600 mg, due to failed dissolution specifications found during stability testing that may affect medication efficacy.

    Product
    Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD 21202 by Lupin Limited, Nagpur-441108, India, NDC 68180-169-16
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0875-2022·2022-05-25

    Lupin Pharmaceuticals Recalls GaviLyte-C Laxative Powder Due to Failed Stability Testing

    Lupin Pharmaceuticals is recalling GaviLyte-C bowel-preparation powder nationwide (26,910 bottles) because the product failed stability testing, potentially indicating degraded ingredients or reduced effectiveness. Patients should contact their doctor for a replacement.

    Product
    GAVILYTE - C — GAVILYTE - C (POLYETHYLENE GLYCOL-3350 AND ELECTROLYTES WITH FLAVOR PACK)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0839-2022·2022-05-11

    Losartan Potassium Tablets Recalled Due to Unacceptable Chemical Impurity Levels

    Lupin Pharmaceuticals is recalling 1.47 million bottles of Losartan Potassium Tablets due to chemical impurities exceeding acceptable limits. The affected batches were distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0838-2022·2022-05-11

    Losartan Potassium tablets recalled for AZIDO impurity above limits

    Lupin Pharmaceuticals recalls Losartan Potassium tablets for CGMP deviations with AZIDO impurity above limits. The recall affects 657,336 bottles distributed nationwide; no illnesses reported.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0840-2022·2022-05-11

    Losartan Potassium tablets recalled for manufacturing impurity above limits

    Lupin Pharmaceuticals is recalling Losartan Potassium Tablets 100 mg nationwide due to AZIDO impurity levels exceeding acceptable manufacturing limits. Approximately 1,247,067 bottles were affected.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0843-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide tablets recalled for AZIDO impurity

    Lupin Pharmaceuticals recalls Losartan Potassium and Hydrochlorothiazide tablets nationwide due to manufacturing deviations that resulted in AZIDO impurity levels above acceptable limits.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0841-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide tablets recalled for AZIDO impurity

    Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide tablets distributed nationwide due to elevated AZIDO impurity levels detected during manufacturing quality control.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0842-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Impurity

    Lupin Pharmaceuticals is recalling Losartan Potassium and Hydrochlorothiazide 100 mg/25 mg tablets nationwide due to AZIDO impurity levels above acceptable limits. Patients should consult their healthcare provider about their medication.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0358-2022·2022-01-12

    Oxycodone Hydrochloride Tablets Recalled for Out-of-Specification Impurity

    Lupin Pharmaceuticals is recalling Oxycodone Hydrochloride Tablets (5 mg) due to out-of-specification impurity test results detected during long-term stability testing. Affected units were distributed in New York and Ohio.

    Product
    OXYCODONE HYDROCHLORIDE — OXYCODONE HYDROCHLORIDE (OXYCODONE HYDROCHLORIDE)
    Category
    Drug
    Distribution
    2 states
  • ModerateFDA (Drugs)·D-0326-2022·2022-01-12

    Gatifloxacin Ophthalmic Solution Recall Due to Failed Stability Testing

    Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% because water loss test results fell out of specification, which could affect the drug's assay content and concentration.

    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
  • LowFDA (Drugs)·D-0264-2022·2021-12-08

    Tydemy Oral Contraceptive Recalled Due to Subpotent Drug

    Lupin Pharmaceuticals has recalled Tydemy oral contraceptive tablets nationwide due to subpotency. The recall affects 4,113 cartons distributed throughout the United States.

    Product
    Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets, 0.451 mg), packaged in cartons containing 3 wallets of 28 Tablets each, Rx Only, Distributed by: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202,
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0087-2022·2021-11-10

    Irbesartan Tablets Recalled for Impurity in Active Ingredient

    Lupin Pharmaceuticals is recalling Irbesartan tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects 30-count and 90-count bottles distributed nationwide.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0090-2022·2021-11-10

    Lupin Pharmaceuticals Irbesartan/Hydrochlorothiazide Tablets Recalled for Impurity

    Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets USP (300/12.5 mg) in 30-count and 90-count bottles due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient.

    Product
    Irbesartan and Hydrochlorothiazide Tablets USP, 300/12.5 mg a) 30 count (NDC 68180-414-06) and b) 90 count (NDC 68180-414-09) bottles, Rx only
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-0089-2022·2021-11-10

    Irbesartan and Hydrochlorothiazide Tablets Recalled for Impurity Contamination

    Lupin Pharmaceuticals is recalling Irbesartan and Hydrochlorothiazide Tablets 150/12.5 mg due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient, which resulted from CGMP deviations.

    Product
    Irbesartan and Hydrochlorothiazide Tablets USP, 150/12.5 mg a) 30 count (NDC 68180-413-06) and b) 90 count (NDC 68180-413-09) bottles, Rx only
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0086-2022·2021-11-10

    Lupin Irbesartan Tablets Recalled for Impurity Contamination

    Lupin Pharmaceuticals is recalling Irbesartan 75 mg tablets due to detection of the impurity N-nitrosoirbesartan in the active pharmaceutical ingredient. The recall affects 51,144 bottles distributed nationwide.

    Product
    IRBESARTAN — IRBESARTAN (IRBESARTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0088-2022·2021-11-10

    Irbesartan 300 mg tablets recalled for impurity in active ingredient

    Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.

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