MACLEODS PHARMA USA, INC recalls
Every recall we track for MACLEODS PHARMA USA, INC — 34 in all, from 2015–2026 — plus the complaints and injury reports the public filed about them. 3 are rated “stop using now”.
Recalls per year, by danger level
Recalls from MACLEODS PHARMA USA, INC peaked in 2019 (12); 33 since 2017. 9% rated “stop using now”.
All FDA recall records for MACLEODS PHARMA USA, INC since 2017, counted by recall date (one bar per calendar year; 2026 is partial). Danger level is GovInfoNow’s plain-language rating; “not yet rated” records are still being written up.
| Year | Stop using now | Use caution | Lower risk | Not yet rated | Total |
|---|---|---|---|---|---|
| 2017 | 0 | 0 | 0 | 0 | 0 |
| 2018 | 0 | 0 | 0 | 0 | 0 |
| 2019 | 1 | 1 | 4 | 6 | 12 |
| 2020 | 0 | 0 | 2 | 0 | 2 |
| 2021 | 0 | 0 | 1 | 4 | 5 |
| 2022 | 2 | 1 | 2 | 6 | 11 |
| 2023 | 0 | 0 | 1 | 0 | 1 |
| 2024 | 0 | 1 | 0 | 0 | 1 |
| 2025 | 0 | 0 | 0 | 0 | 0 |
| 2026 (to date) | 0 | 0 | 1 | 0 | 1 |
MACLEODS PHARMA USA, INC recalls before 2017
Recalls on record by year.
Most common reasons for MACLEODS PHARMA USA, INC recalls
What to do if you have a recalled MACLEODS PHARMA USA, INC product
- Match the NDC and lot number on your bottle or box to the recall.
- Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first.
- Report side effects to FDA MedWatch.
All MACLEODS PHARMA USA, INC recalls
21 shown- Lower riskDrug
MACLEODS PHARMA USA, INC recalls Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc.,
Macleods Pharma recalls 150 mcg levothyroxine tablets due to subpotent drug levels. This may not provide proper thyroid hormone treatment. Consumers should contact pharmacy for guidance.
Macleods PharmaFeb 26, 2026 - Use cautionDrug
MACLEODS PHARMA USA, INC recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 50mg /12.5 mg, 1000-count bottle, Rx only, Manufactured for:
Macleods Pharma recalls 1048 bottles of Losartan Potassium and Hydrochlorothiazide tablets due to a plastic-like foreign substance. Check your lot number.
Macleods Pharma USAMay 7, 2024 - Lower riskDrug
MACLEODS PHARMA USA, INC recalls Levofloxacin Tablets, USP 500 mg; 50-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Princeton, NJ
Macleods Pharma USA recalls 50-count Levofloxacin 500mg tablets due to embossing mismatch with package inserts. This may cause confusion in identifying the correct medication.
Macleods PharmaJan 5, 2023 - Lower riskDrug
Macleods Pharma Usa Inc recalls Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc.,
Macleods Pharma recalls 1mg Eszopiclone tablets in 30-count bottles due to customer reports of missing tablets. Affected units may have 1-3 tablets missing from the bottle.
MacleodsJun 16, 2022 - UnratedDrug
Macleods Pharma Usa Inc recalls Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 count NDC # 33342-052-07, NDC
Macleods Pharma recalls Losartan-Hydrochlorothiazide tablets due to AZIDO impurity levels exceeding safety limits. Affected lots may pose health risks if taken.
Macleods PharmaJun 10, 2022 - UnratedDrug
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets, USP, 50 mg, a) 30-count bottles (NDC # 33342-045-07), b) 90-count bottles (NDC #
Macleods Pharma recalls 50mg Losartan Potassium Tablets due to AZIDO impurity levels exceeding safety limits. Affected lots include BLI2002A through BLI2104B. Contact for return instructions.
Macleods PharmaApr 15, 2022 - Lower riskDrug
Macleods Pharma Usa Inc recalls Risedronate Sodium Tablets, USP, 5 mg, Rx Only, 30-count bottle, Manufactured for: Macleods Pharma USA, Plainsboro, NJ
Macleods Pharma recalls 5mg Risedronate tablets due to failed content uniformity. Affected lots may not contain correct active ingredient levels.
MacleodsMar 10, 2022 - UnratedDrug
Macleods Pharma Usa Inc recalls Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA , Inc. Plainsboro, NJ
Macleods Pharma USA recalls 10mg Olanzapine tablets due to cGMP deviations. Affected lots: BOB42029A, BOB4202B. Expired 09/2022. No specific remedy stated in recall.
MacleodsFeb 16, 2022 - Use cautionDrug
Macleods Pharma Usa Inc recalls Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma
Macleods Pharma USA recalls specific lots of Amlodipine and Olmesartan Medoxomil tablets due to current Good Manufacturing Practice deviations.
Macleods PharmaFeb 15, 2022 - UnratedDrug
MACLEODS PHARMA USA, INC recalls Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2X6 Unit-Dose Tablets) Blister Packs, NDC
Macleods Pharma recalls 10mg Rizatriptan Benzoate Film Coated Tablets due to organic impurities found in testing. Affected lots expire 04/2024. No specific remedy provided in recall notice.
Macleods PharmaOct 18, 2021 - Lower riskDrug
Macleods Pharma Usa Inc recalls Clopidogrel Tablets, USP, 75 mg, 500-count bottle, Rx only, Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ
Macleods Pharma USA recalls 75mg Clopidogrel tablets due to foreign matter. Rx-only 500-count bottles with specific lot number and expiration date.
MacleodsAug 2, 2021 - UnratedDrug
Macleods Pharma Usa Inc recalls Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc.,
Macleods Pharma recalls 4mg Candesartan tablets due to failed impurities. Affected lots from ECD5908C to ECD5912A, expiring 07/2021 and 09/2021. Stop using if you have these specific lots.
MacleodsMar 22, 2021 - Lower riskDrug
Macleods Pharma Usa Inc recalls Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods
Macleods Pharma recalls 15mg/500mg Pioglitazone and Metformin tablets due to subpotent drug levels. These prescription pills may not contain enough active ingredients. Check your prescription bottles for lot numbers BPA5903A or BPA5819A.
MacleodsJan 24, 2020 - Lower riskDrug
Macleods Pharma Usa Inc recalls Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc.
Macleods Pharma USA recalls 5mg Montelukast chewable tablets due to failed dissolution testing in one batch. Affected products have NDC 33342-111-10 and Lot BMD8901B. No specific remedy provided in recall notice.
MacleodsJan 20, 2020 - UnratedDrug
Macleods Pharma Usa Inc recalls Pioglitazone Hydrochloride Tablets USP 15 mg, 30 count bottles, Rx only, Manufactured for: Macleods Pharma USA, Inc.,
Macleods Pharma recalls 15mg Pioglit: Superpotent risk in 30-count bottles. Rx only. Check NDC 33342-054-07 and lot BPF901A.
MacleodsSep 23, 2019 - Lower riskDrug
Macleods Pharma Usa Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc.
Macleods Pharma recalls 0.125mg pramipexole tablets due to stability study showing subpotent drug. Patients should contact their doctor for alternative treatment options.
MacleodsAug 21, 2019 - Lower riskDrug
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)
Macleods Pharma recalls 0.4 mg Tamsulosin capsules with failed dissolution specs. These prescription capsules may not work as intended. Contact for return instructions.
MacleodsJul 17, 2019 - UnratedDrug
Macleods Pharma Usa Inc recalls Losartan Potassium Tablets 50 mg 1000 Tablets, USP Rx Only Manufactured for: Macleods Pharma USA inc. Plainsboro, NJ
Macleods Pharma USA recalls 50mg Losartan Potassium Tablets due to impurity detected in active ingredient. Prescription-only medication with NDC 33342-045-44 manufactured Nov 2019.
MacleodsJun 20, 2019 - Use cautionDrug
Macleods Pharma Usa Inc recalls Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma
Macleods Pharma USA recalls specific lots of Telmisartan and Hydrochlorothiazide tablets because they failed content uniformity specifications.
Macleods PharmaFeb 25, 2019 - Stop using nowDrug
Macleods Pharma Usa Inc recalls Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/25 mg, 90 count bottles, Rx Only, Manufactured for:
Macleods Pharma recalls 90-count bottles of Losartan Potassium and Hydrochlorothiazide tablets due to carcinogen impurity. Check your lot number.
Macleods PharmaFeb 21, 2019 - Use cautionDrug
Macleods Pharma Usa Inc recalls Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc.,
Macleods Pharma USA recalls specific lots of Pramipexole Dihydrochloride 0.125 mg tablets due to the presence of a comingled Carbimazole tablet.
Macleods Pharma USADec 24, 2015
MACLEODS PHARMA USA, INC recall questions
How many recalls has MACLEODS PHARMA USA, INC had?
34 recalls from MACLEODS PHARMA USA, INC are on record with U.S. safety agencies, from 2015–2026.
What is the most recent MACLEODS PHARMA USA, INC recall?
MACLEODS PHARMA USA, INC recalls Levothyroxine Sodium Tablets USP 150 mcg, 1000 Tablets bottle, Rx Only, Manufactured for: Macleods Pharma USA, Inc.,, dated Feb 26, 2026. Every MACLEODS PHARMA USA, INC recall is listed on this page, newest first.
Why are MACLEODS PHARMA USA, INC products recalled?
The most common reasons on record: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits (7).
What should I do if I have a recalled MACLEODS PHARMA USA, INC product?
Match the NDC and lot number on your bottle or box to the recall. Don’t stop a prescription on your own — ask your pharmacist or doctor for a replacement first. Report side effects to FDA MedWatch.
How do I get alerts for new MACLEODS PHARMA USA, INC recalls?
Sign up for free email alerts on GovInfoNow — we check official CPSC, FDA, USDA and NHTSA data every day and email you only when a recall matches what you follow.