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Macleods Pharma Usa Inc
Macleods Pharma Usa Inc: 34 FDA recall reports
Every drug recall the FDA has published for Macleods Pharma Usa Inc. The fault, and how the agency graded it.
34Reports
0Class I
2Ongoing
2026-04-01Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
By year reported
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA,
D-0403-2026 · Class II · reported 2026-04-01 · Ongoing
- Why it was recalled
- Subpotent Drug
- Product
- 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 33342-401-44
- Where it went
- Nationwide
- How much
- 1315 bottles
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufacture
D-0498-2024 · Class II · reported 2024-05-22 · Ongoing
- Why it was recalled
- Presence of foreign substance: plastic-like substance.
- Product
- 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, Himachal Pradesh, INDIA, NDC 33342-050-44
- Where it went
- USA Nationwide
- How much
- 1,048 bottles
Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princ
D-0162-2023 · Class III · reported 2023-01-25 · Terminated
- Why it was recalled
- Mismatching of the embossing on the tablets (T7) with the embossing mentioned in the package insert (ML63) in the distributed bottles.
- 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
- Where it went
- Nationwide within United States and Puerto Rico.
- How much
- 10052 bottles
Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA,
D-1174-2022 · Class II · reported 2022-07-13 · Terminated
- Why it was recalled
- Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles.
- Product
- 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, NDC 33342-299-07
- Where it went
- Distributed Nationwide and Puerto Rico.
- How much
- 168690 Tablets
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC #3
D-1164-2022 · Class II · reported 2022-07-06 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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
- Where it went
- Product was distributed nationwide.
- How much
- 84/1000 count bottles
Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC # 3
D-0833-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- 3216/30 count bottles; 47,904/90 count bottles; 4269/1000 count bottles = 8,676,840 tablets
Losartan Potassium Tablets, USP, 25 mg, a) 90-count bottles (NDC # 33342-044-10), b) 1000-count bottles (NDC #
D-0832-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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
- Where it went
- Product was distributed nationwide.
- How much
- 12,408/90 count bottles; 1670/1000 count bottles =2,786,720 tablets
Losartan Potassium Tablets, USP, 100 mg, a) 30-count bottles (NDC # 33342-046-07), b) 90-count bottles (NDC #
D-0834-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- 3288/30 count bottles; 23,904/90 count bottles; 3364/1000 count bottles = 5,614,000 tablets
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 50 mg/12.5 mg, a) 30-count bottles (NDC# 33342-050-07),
D-0835-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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 Pharma USA, Inc. Plainsboro, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- N/A
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/25 mg, a) 30-count bottles (NDC# 33342-052-07),
D-0836-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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 Pharma USA, Inc. Plainsboro, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- N/A
Losartan Potassium & Hydrochlorothiazide Tablets, USP, 100 mg/12.5 mg, a) 30-count bottles (NDC# 33342-051-07)
D-0837-2022 · Class II · reported 2022-05-11 · Terminated
- Why it was recalled
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
- Product
- 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 Pharma USA, Inc. Plainsboro, NJ 08536
- Where it went
- Product was distributed nationwide.
- How much
- N/A
Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plains
D-0762-2022 · Class III · reported 2022-04-13 · Terminated
- Why it was recalled
- FAILED CONTENT UNIFORMITY SPECIFICATIONS
- Product
- 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 33342-107-07.
- Where it went
- USA Nationwide
- How much
- 4872 bottles
Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsb
D-0639-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- cGmp Deviations
- Product
- 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 33342-070-07.
- Where it went
- Nationwide within the United States
- How much
- 3672 bottles
Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleo
D-0632-2022 · Class II · reported 2022-03-09 · Terminated
- Why it was recalled
- cGMP deviations
- Product
- 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 Pradesh, INDIA, NDC 33342-192-07.
- Where it went
- USA Nationwide
- How much
- 3,672 bottles
Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Pac
D-0078-2022 · Class III · reported 2021-11-03 · Terminated
- Why it was recalled
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Product
- 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: Macleods Pharma USA, Inc. Plainsboro, NJ 08536l Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA
- Where it went
- Nationwide within the United States
- How much
- 135,082 Blister Packs/2,431,476 tablets
Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Unit-Dose Tablets) Blister Packs, R
D-0080-2022 · Class III · reported 2021-11-03 · Terminated
- Why it was recalled
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Product
- 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 Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-094-41
- Where it went
- Nationwide within the United States
- How much
- 643,800 Blister Packs /888,336 Tablets
Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Unit-Dose Tablets) Blister Packs, Rx
D-0079-2022 · Class III · reported 2021-11-03 · Terminated
- Why it was recalled
- Out-of-specification test results obtained in Organic Impurities test during analysis of controlled samples.
- Product
- 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 Pharmaceuticals Ltd. Baddi, Himachal Pradesh, INDIA, NDC 33342-093-41
- Where it went
- Nationwide within the United States
- How much
- 13,260 Blister Packs/238,680 tablets
Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plain
D-0787-2021 · Class II · reported 2021-09-08 · Terminated
- Why it was recalled
- Presence of foreign matter
- Product
- 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 33342-060-15
- Where it went
- Product was distributed nationwide.
- How much
- 444,000 tablets / 888 unit packs of 500 count
Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, In
D-0329-2021 · Class III · reported 2021-04-21 · Terminated
- Why it was recalled
- Failed Impurities/Degradation Specifications
- Product
- 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 33342-114-10
- Where it went
- Nationwide within the United States
- How much
- 8015 packs
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for
D-0838-2020 · Class III · reported 2020-02-12 · Terminated
- Why it was recalled
- Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
- Product
- 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, Himachal Pradesh, India, NDA 33342-176-09
- Where it went
- Nationwide
- How much
- 4694 30x60-count bottles
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA,
D-0823-2020 · Class III · reported 2020-02-05 · Terminated
- Why it was recalled
- Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
- Product
- 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 33342-111-10
- Where it went
- Nationwide within the United States
- How much
- 10680 units
Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA
D-0140-2020 · Class II · reported 2019-10-23 · Terminated
- Why it was recalled
- Superpotent
- Product
- 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 33342-054-07
- Where it went
- Product was shipped to 8 distributors who may have further distributed the product.
- How much
- 31,968 bottles
Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA,
D-1851-2019 · Class III · reported 2019-09-18 · Terminated
- Why it was recalled
- Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
- Product
- 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 33342-031-10
- Where it went
- Distributed Nationwide in the USA
- How much
- 1837 90-count bottles
Tamsulosin Hydrochloride Capsules, USP 0.4 mg Rx only a) 100 count (NDC 33342-159-11), b) 500 count (NDC 333
D-1844-2019 · Class II · reported 2019-08-21 · Terminated
- Why it was recalled
- Failed Dissolution Specifications
- Product
- 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, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himchal Pradesh, INDIA
- Where it went
- Nationwide
- How much
- a) 5448 bottles b) 972 bottles c) 158 bottles
Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsb
D-1458-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Product
- 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 33342-045-44
- Where it went
- Nationwide
- How much
- 4277 bottles (4,277,000 tablets)
Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 90 Tablets, USP Manufactured for: Macle
D-1459-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Product
- 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 Pradesh, INDIA NDC 33342-050-10
- Where it went
- Nationwide
- How much
- 142626 bottles (12,836,340 tablets)
Losartan Potassium Tablets, USP 50 mg 90 tablets Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro
D-1457-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Product
- 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
- Where it went
- Nationwide
- How much
- 47520 bottles (4,276,800 tablets)
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 90 Tablets, USP Manufactured for: Macl
D-1460-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Product
- 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 Pradesh, INDIA NDC 33342-051-10
- Where it went
- Nationwide
- How much
- 29106 bottles (2,619,540 tablets)
Losartan Potassium andHydrochlorothiazide Tablets 100 mg/25 mg 90 tablets, USP Rx Only, Manufactured for: Mac
D-1461-2019 · Class II · reported 2019-07-17 · Terminated
- Why it was recalled
- CGMP Deviations: impurity for N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) detected in the active pharmaceutical ingredient (API) used to manufacture finished products.
- Product
- 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 Pradesh, INDIA NDC 33342-052-10
- Where it went
- Nationwide
- How much
- 145162 bottles (13,064,580 tablets)
Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured
D-1040-2019 · Class II · reported 2019-03-27 · Terminated
- Why it was recalled
- CGMP Deviation: Presence of NDEA (N-Nitrosodimethylamine), a carcinogen impurity, detected in the active ingredient.
- Product
- 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, Himachal Pradesh, India. NDC 33342-0052-10
- Where it went
- NJ, NY, FL
- How much
- 9695 bottles
Showing the 30 most recent of 34. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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