The Recall Desk

Manufacturer

Macleods Pharma Usa Inc

34 recalls in our database name Macleods Pharma Usa Inc as the manufacturing or recalling firm.

What the numbers show

Total
34
Critical
0
Severe
5
Most recent
2026-04-01

Of the 34 recalls from Macleods Pharma Usa Inc we have scored against our rubric, 0 (0%) are Critical — deaths or serious injuries reported, or the agency’s own highest classification — and 5 (15%) 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 34

  • HighFDA (Drugs)·D-0498-2024·2024-05-22

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Foreign Plastic Contamination

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (50 mg/12.5 mg, lot BLK2304A) due to the presence of a plastic-like foreign substance. The recall affects 1,048 bottles distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0162-2023·2023-01-25

    Levofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch

    Macleods Pharma USA recalls Levofloxacin Tablets 500 mg due to mismatched embossing on tablets versus the package insert labeling. The distributed bottles do not match the documented tablet markings.

    Product
    Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540; Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India. NDC 33342-022-08
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1174-2022·2022-07-13

    Eszopiclone sleep medication recalled nationwide for shortfill packaging defect

    Macleods Pharma USA Inc is recalling Eszopiclone 1 mg tablets due to shortfill—customers reported one to three missing tablets from 30-count bottles. Affected lot BEK2009A (exp. 11/2023) was distributed nationwide and to Puerto Rico.

    Product
    ESZOPICLONE — ESZOPICLONE (ESZOPICLONE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-1164-2022·2022-07-06

    FDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets (100 mg/25 mg) due to CGMP deviations and azido impurity levels exceeding acceptable limits. The affected lot is BLM2114A (expiration 07/2023) distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0832-2022·2022-05-11

    Losartan Potassium Tablets Recalled Due to AZIDO Impurity Above Limits

    Macleods Pharma USA Inc. is recalling Losartan Potassium 25 mg tablets due to higher-than-acceptable levels of AZIDO impurity from manufacturing deviations. The affected lots were distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0834-2022·2022-05-11

    Losartan Potassium Tablets Recalled for Excessive Azido Impurity

    Macleods Pharma is recalling Losartan Potassium Tablets due to CGMP deviations with azido impurity levels exceeding acceptable limits. The recall affects 5.6 million tablets distributed nationwide.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0833-2022·2022-05-11

    Losartan Potassium Tablets Recalled for Manufacturing Impurity Above Acceptable Limits

    Macleods Pharma USA is recalling Losartan Potassium 50 mg tablets nationwide due to CGMP deviations with AZIDO impurity levels above acceptable limits. Affected lots: BLI2002A, BLI2004A, and BLI2104B.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0835-2022·2022-05-11

    Losartan potassium and hydrochlorothiazide tablets recalled for manufacturing quality deviations

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to manufacturing quality issues with chemical impurity levels above acceptable limits. Affected lots were distributed nationwide in 30-, 90-, and 1000-count bottles.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • HighFDA (Drugs)·D-0836-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled for Manufacturing Defect

    Macleods Pharma USA Inc is recalling multiple lots of Losartan Potassium and Hydrochlorothiazide tablets (NDC# 33342-052-07, 33342-052-10, 33342-052-44) distributed nationwide due to AZIDO impurity levels exceeding acceptable limits.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0837-2022·2022-05-11

    Losartan Potassium and Hydrochlorothiazide Tablets Recalled Due to AZIDO Impurity Contamination

    Macleods Pharma USA is recalling Losartan Potassium and Hydrochlorothiazide tablets due to AZIDO impurity levels exceeding acceptable manufacturing standards. The prescription blood pressure medication was distributed nationwide.

    Product
    LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE — LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0762-2022·2022-04-13

    Risedronate Sodium Tablets Recalled for Failed Content Uniformity Specifications

    Macleods Pharma USA Inc is recalling Risedronate Sodium 5 mg tablets (Lot BRD2001A, expiration 5/2022) due to failed content uniformity specifications. The recall affects 4,872 bottles distributed nationwide.

    Product
    RISEDRONATE SODIUM — RISEDRONATE SODIUM (RISEDRONATE SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0639-2022·2022-03-09

    Olanzapine 10 mg tablets recalled due to cGMP deviations

    Macleods Pharma USA is voluntarily recalling Olanzapine 10 mg tablets nationwide due to cGMP (current good manufacturing practices) deviations identified during manufacturing. The recall affects 3,672 bottles distributed across the United States.

    Product
    OLANZAPINE — OLANZAPINE (OLANZAPINE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0632-2022·2022-03-09

    Amlodipine and Olmesartan Medoxomil Tablets Recalled for cGMP Deviations

    Macleods Pharma USA is recalling one lot of Amlodipine and Olmesartan Medoxomil Tablets nationwide due to current Good Manufacturing Practice (cGMP) deviations. The recall is voluntary and was initiated by the manufacturer.

    Product
    AMLODIPINE AND OLMESARTAN MEDOXOMIL — AMLODIPINE AND OLMESARTAN MEDOXOMIL (AMLODIPINE AND OLMESARTAN MEDOXOMIL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0078-2022·2021-11-03

    Rizatriptan Benzoate Tablets Recall Due to Out-of-Specification Impurities

    MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.

    Product
    RIZATRIPTAN — RIZATRIPTAN (RIZATRIPTAN)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0079-2022·2021-11-03

    Rizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities

    Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.

    Product
    RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0787-2021·2021-09-08

    Clopidogrel Tablets Recalled for Foreign Matter Contamination

    Macleods Pharma USA is recalling Clopidogrel 75 mg tablets due to the presence of foreign matter in the product. The affected lot was distributed nationwide.

    Product
    CLOPIDOGREL — CLOPIDOGREL (CLOPIDOGREL)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0838-2020·2020-02-12

    Macleods Pharma Recalls Subpotent Pioglitazone and Metformin Tablets

    Macleods Pharma USA is recalling two lots of Pioglitazone and Metformin Hydrochloride tablets because they tested below the required potency levels.

    Product
    PIOGLITAZONE AND METFORMIN HYDROCHLORIDE — PIOGLITAZONE AND METFORMIN HYDROCHLORIDE (PIOGLITAZONE AND METFORMIN HYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-0823-2020·2020-02-05

    Macleods Pharma Recalls Montelukast Sodium Chewable Tablets for Dissolution Failure

    Macleods Pharma USA is recalling 10,680 bottles of Montelukast Sodium Chewable Tablets, 5 mg, because testing revealed low out-of-specification dissolution results in one lot.

    Product
    MONTELUKAST SODIUM — MONTELUKAST SODIUM (MONTELUKAST SODIUM)
    Category
    Drug
    Distribution
    Distributed nationwide
  • ModerateFDA (Drugs)·D-1851-2019·2019-09-18

    Macleods Recalls Pramipexole Dihydrochloride Tablets Due to Subpotency

    Macleods Pharma USA is recalling Pramipexole Dihydrochloride Tablets 0.125 mg because stability studies showed the drug was subpotent.

    Product
    PRAMIPEXOLE DIHYDROCHLORIDE — PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
    Category
    Drug
    Distribution
    Distributed nationwide
  • SevereFDA (Drugs)·D-1458-2019·2019-07-17

    Macleods Pharma Recalls Losartan Potassium Tablets Due to Impurity

    Macleods Pharma USA Inc. is recalling Losartan Potassium 50 mg tablets because an impurity was detected in the active ingredient.

    Product
    LOSARTAN POTASSIUM — LOSARTAN POTASSIUM (LOSARTAN POTASSIUM)
    Category
    Drug
    Distribution
    Distributed nationwide