Macleods Pharma USA recalls

Macleods Pharma USA has 34 recalls on record with the FDA and USDA, the earliest in 2016 and the latest reported on 1 Apr 2026. 2 are still ongoing. 1 was reported in the last 12 months. The most frequent reason is potency & assay.

Total recalls34since 2016

Last 12 months1reported

Class I00% of total

Ongoing2latest 1 Apr 2026

Recalls per month, last 24 months

click a bar for that month

0Nov '24 0 0 0Feb 0 0 0May 0 0 0Aug 0 0 0Nov 0 0 0Feb 0 1 0May 0 0 0Aug 0 0

Severity split

Class I 0 0%Class II 25 74%Class III 9 26%

Why macleods pharma usa is recalled

Product types

Brands

Losartan Potassium And Hydrochlorothiazide824%
Losartan Potassium515%
Pramipexole Dihydrochloride26%
Rizatriptan Benzoate26%
Montelukast Sodium13%
Pioglitazone13%
Tamsulosin Hydrochloride13%
Levothyroxine Sodium13%

By year

202613%
202413%
202313%
20221132%
2021515%
202026%
20191235%
201613%

Ongoing macleods pharma usa recalls

2 active

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Drug	CLASS II	Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium	Macleods Pharma USA	Potency & Assay	Nationwide
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide

All macleods pharma usa recalls, newest first

34 total

Reported	Class	Recall	Company	Reason	Where
1 Apr 2026Drug	CLASS II	Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium	Macleods Pharma USA	Potency & Assay	Nationwide
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
25 Jan 2023Drug	CLASS III	Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa	Macleods Pharma USA	Packaging Defects	Nationwide
13 Jul 2022Drug	CLASS II	Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone	Macleods Pharma Usa	Packaging Defects	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022Drug	CLASS II	Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022Drug	CLASS II	Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022Drug	CLASS II	Losartan Potassium & Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022Drug	CLASS II	Losartan Potassium Tablets, USP, 100 mg, a) bottles recalledLosartan Potassium	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022Drug	CLASS II	Losartan Potassium Tablets, USP, 25 mg, a) bottles recalledLosartan Potassium	Macleods Pharma Usa	Potency & Assay	Nationwide
11 May 2022Drug	CLASS II	Losartan Potassium Tablets, USP, 50 mg, a) bottles recalledLosartan Potassium	Macleods Pharma Usa	Potency & Assay	Nationwide
13 Apr 2022Drug	CLASS III	Risedronate Sodium Tablets, USP, 5 mg recalled by Macleods Pharma UsaRisedronate Sodium	Macleods Pharma Usa	Other	Nationwide
9 Mar 2022Drug	CLASS II	Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg recalledAmlodipine And Olmesartan Medoxomil	Macleods Pharma Usa	Manufacturing (CGMP) Deviations	Nationwide
9 Mar 2022Drug	CLASS II	Olanzapine Tablets, USP 10 mg recalled by Macleods Pharma UsaOlanzapine	Macleods Pharma Usa	Manufacturing (CGMP) Deviations	Nationwide
3 Nov 2021Drug	CLASS III	Rizatriptan Benzoate Orally Disintegrating Tablets 5mg recalledRizatriptan Benzoate	Macleods Pharma USA	Potency & Assay	Nationwide
3 Nov 2021Drug	CLASS III	Rizatriptan Benzoate Orally Disintegrating Tablets 10mg recalledRizatriptan Benzoate	Macleods Pharma USA	Potency & Assay	Nationwide
3 Nov 2021Drug	CLASS III	Rizatriptan Benzoate Film Coated Tablets, 10 mg recalledRizatriptan	Macleods Pharma USA	Potency & Assay	Nationwide
8 Sep 2021Drug	CLASS II	Clopidogrel Tablets, USP, 75 mg recalled by Macleods Pharma UsaClopidogrel	Macleods Pharma Usa	Foreign Material	Nationwide
21 Apr 2021Drug	CLASS III	Candesartan Cilexetil Tablets, USP, 4 mg recalled by Macleods Pharma UsaCandesartan	Macleods Pharma Usa	Potency & Assay	Nationwide
12 Feb 2020Drug	CLASS III	Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg recalled	Macleods Pharma Usa	Potency & Assay	Nationwide
5 Feb 2020Drug	CLASS III	Montelukast Sodium Chewable Tablets, 5 mg recalledMontelukast Sodium	Macleods Pharma Usa	Potency & Assay	Nationwide
23 Oct 2019Drug	CLASS II	Pioglitazone Hydrochloride Tablets USP 15 mg recalledPioglitazone	Macleods Pharma Usa	Potency & Assay	NJ
18 Sep 2019Drug	CLASS III	Pramipexole Dihydrochloride Tablets 0.125 mg recalledPramipexole Dihydrochloride	Macleods Pharma Usa	Potency & Assay	Nationwide
21 Aug 2019Drug	CLASS II	Tamsulosin Hydrochloride Capsules, USP 0.4 mg recalledTamsulosin Hydrochloride	Macleods Pharma Usa	Potency & Assay	Nationwide
17 Jul 2019Drug	CLASS II	Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Nitrosamine Impurity	Nationwide
17 Jul 2019Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Nitrosamine Impurity	Nationwide
17 Jul 2019Drug	CLASS II	Losartan Potassium Tablets, USP 50 mg recalled by Macleods Pharma UsaLosartan Potassium	Macleods Pharma Usa	Nitrosamine Impurity	Nationwide
17 Jul 2019Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Nitrosamine Impurity	Nationwide
17 Jul 2019Drug	CLASS II	Losartan Potassium Tablets 50 mg recalled by Macleods Pharma UsaLosartan Potassium	Macleods Pharma Usa	Nitrosamine Impurity	Nationwide
27 Mar 2019Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg recalled	Macleods Pharma Usa	Nitrosamine Impurity	FL, NJ, NY

About this list

Records come from FDA enforcement reports and USDA FSIS notices, grouped by normalised name. A company operating under several names may appear more than once.