Plainsboro, NJ, United States
Macleods Pharma Usa Inc recalls
20 recalls recorded since 2018, most recently on 26 February 2026. 2 are listed as ongoing. Status and classification are as published by the FDA.
Recalls20
Ongoing (FDA)2
Terminated or completed18
Class I (FDA)0
Ongoing Class II Drugs
- Recall started
- 26 February 2026
- Reason
- Subpotent Drug
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0403-2026
- Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Princeton, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Sarigam, Valsad, Guajarat, INDIA NDC 333
Ongoing Class II Drugs
- Recall started
- 7 May 2024
- Reason
- Presence of foreign substance: plastic-like substance.
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0498-2024
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ 08540, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Hi
Terminated Class III Drugs
- Recall started
- 5 January 2023
- Terminated
- 24 June 2025
- Reason
- Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
- Distribution
- Nationwide within United States and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0162-2023
- 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-
Terminated Class II Drugs
- Recall started
- 16 June 2022
- Terminated
- 20 March 2024
- Reason
- Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
- Distribution
- Distributed Nationwide and Puerto Rico.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1174-2022
- Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA, ND
Terminated Class II Drugs
- Recall started
- 10 June 2022
- Terminated
- 23 May 2024
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1164-2022
- Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #33342-052-10 & NDC # 33342-052-44, Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
Terminated Class II Drugs
- Recall started
- 15 April 2022
- Terminated
- 13 October 2023
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0833-2022, D-0832-2022, D-0834-2022, D-0835-2022, D-0836-2022, D-0837-2022
- Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 33342-045-10), c) 1000-count bottles (NDC # 33342-045-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro,
- Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC # 33342-044-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro, NJ 08536
- Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC # 33342-046-10), c) 1000-count bottles (NDC # 33342-046-44), Rx Only, MFR: Macleods Pharma USA, Inc. Plainsboro,
- Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07), b) 90-count bottles (NDC # 33342-050-10) c) 1000-count bottles (NDC # 33342-050-44), Rx Only, MFR: Macleods
- Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07), b) 90-count bottles (NDC # 33342-052-10) c) 1000-count bottles (NDC # 33342-052-44), Rx Only, MFR: Macleods P
- Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07), b) 90-count bottles (NDC # 33342-051-10) c) 1000-count bottles (NDC # 33342-051-44), Rx Only, MFR: Macleods
Terminated Class III Drugs
- Recall started
- 10 March 2022
- Terminated
- 29 June 2023
- Reason
- FAILED CONTENT UNIFORMITY SPECIFICATIONS
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0762-2022
- Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., BAddi, HImchal Pradesh, INDIA, NDC 33342-107-0
Terminated Class II Drugs
- Recall started
- 16 February 2022
- Terminated
- 16 October 2023
- Reason
- cGmp Deviations
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0639-2022
- Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, HImachal Pradesh, India, NDC 33342-070-0
Terminated Class II Drugs
- Recall started
- 15 February 2022
- Terminated
- 17 February 2023
- Reason
- cGMP deviations
- Distribution
- USA Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0632-2022
- Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals, Ltd, Baddi, Himachal Pra
Terminated Class III Drugs
- Recall started
- 18 October 2021
- Terminated
- 24 April 2024
- Reason
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-0078-2022, D-0080-2022, D-0079-2022
- Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC 33342-088-45), b) 18 Tablets (3 x 6 Unit-Dose Tablets, NDC 33342-088-41) Rx only, Manufactured for: Ma
- Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuti
- Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx only, Manufactured for: Macleods Pharma USA Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuti
Terminated Class II Drugs
- Recall started
- 2 August 2021
- Terminated
- 2 December 2022
- Reason
- Presence of foreign matter
- Distribution
- Product was distributed nationwide.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0787-2021
- Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceutical Ltd., Baddi, Himachal, Pradesh, INDIA NDC 33342-060
Terminated Class III Drugs
- Recall started
- 22 March 2021
- Terminated
- 13 December 2022
- Reason
- Failed Impurities/Degradation Specifications
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0329-2021
- Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Daman (U.T.), India, NDC 33342-114-1
Terminated Class III Drugs
- Recall started
- 24 January 2020
- Terminated
- 16 December 2022
- Reason
- Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0838-2020
- Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himacha
Terminated Class III Drugs
- Recall started
- 20 January 2020
- Terminated
- 26 April 2021
- Reason
- Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0823-2020
- Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-11
Terminated Class II Drugs
- Recall started
- 23 September 2019
- Terminated
- 23 February 2021
- Reason
- Superpotent
- Distribution
- Product was shipped to 8 distributors who may have further distributed the product.
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-0140-2020
- Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, India NDC 33
Terminated Class III Drugs
- Recall started
- 21 August 2019
- Terminated
- 28 January 2021
- Reason
- Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
- Distribution
- Distributed Nationwide in the USA
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1851-2019
- Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Phamaceuticals Ltd. Baddi Himachal Pradesh, India. NDC 3
Terminated Class II Drugs
- Recall started
- 17 July 2019
- Terminated
- 9 February 2021
- Reason
- Failed Dissolution Specifications
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1844-2019
- Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 33342-159-15) and c) 1000 count (NDC 33342-159-44) bottles, Manufactured : Macleods Pharma USA, Inc Plainsboro, N
Terminated Class II Drugs
- Recall started
- 20 June 2019
- Terminated
- 26 October 2021
- Reason
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Distribution
- Nationwide
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1458-2019, D-1459-2019, D-1457-2019, D-1460-2019, D-1461-2019
- Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pra
- Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pradesh, INDIA NDC 33342-045-10
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal Pr
- Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals, Ltd. Baddi, Himachal P
Terminated Class II Drugs
- Recall started
- 25 February 2019
- Terminated
- 12 July 2021
- Reason
- Failed Content Uniformity Specifications: The product is out of specification for blend uniformity.
- Distribution
- Nationwide within the United States
- Initiated
- Voluntary: Firm initiated
- Recall numbers
- D-1005-2019, D-1003-2019, D-1004-2019
- Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh,
- Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Prade
- Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pra
Terminated Class II Drugs
- Recall started
- 21 February 2019
- Terminated
- 28 September 2020
- Reason
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Distribution
- NJ, NY, FL
- Initiated
- Voluntary: Firm initiated
- Recall number
- D-1040-2019
- Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi,
A terminated FDA recall means the FDA has determined that all reasonable efforts to remove or correct the product have been made. What statuses mean.