Home / Brands / MACLEODS PHARMA USA
MACLEODS PHARMA USA Recalls
34 recalls on record · February 17, 2016 to April 1, 2026 · Drugs
Recalls by year
16
19
20
21
22
23
24
26
Count of recall notices naming this brand, by the year the recall was announced. A quiet year is not proof of a safe year.
April 1, 2026DrugsFDA
MACLEODS PHARMA USA, INC recalls Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Pri
Hazard: Subpotent Drug
May 22, 2024DrugsFDA
MACLEODS PHARMA USA, INC recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Mac
Hazard: Presence of foreign substance: plastic-like substance.
January 25, 2023DrugsFDA
MACLEODS PHARMA USA, INC recalls Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 0
Hazard: Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
July 13, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plai
Hazard: Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
July 6, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-1
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-co
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-coun
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-cou
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-1
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
May 11, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044
Hazard: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
April 13, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 0
Hazard: FAILED CONTENT UNIFORMITY SPECIFICATIONS
March 9, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08
Hazard: cGmp Deviations
March 9, 2022DrugsFDA
Macleods Pharma Usa Inc recalls Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma
Hazard: cGMP deviations
November 3, 2021DrugsFDA
MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Ma
Hazard: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
November 3, 2021DrugsFDA
MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Ma
Hazard: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
November 3, 2021DrugsFDA
MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33
Hazard: Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
September 8, 2021DrugsFDA
Macleods Pharma Usa Inc recalls Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ
Hazard: Presence of foreign matter
April 21, 2021DrugsFDA
Macleods Pharma Usa Inc recalls Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plains
Hazard: Failed Impurities/Degradation Specifications
February 12, 2020DrugsFDA
Macleods Pharma Usa Inc recalls Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods
Hazard: Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
February 5, 2020DrugsFDA
Macleods Pharma Usa Inc recalls Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plain
Hazard: Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
October 23, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Pl
Hazard: Superpotent
September 18, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plain
Hazard: Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
August 21, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15)
Hazard: Failed Dissolution Specifications
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Phar
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharm
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
July 17, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536
Hazard: CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
March 27, 2019DrugsFDA
Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macl
Hazard: CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.