Macleods Recalls Pramipexole Dihydrochloride Tablets Due to Subpotency
Macleods Pharma USA is recalling Pramipexole Dihydrochloride Tablets 0.125 mg because stability studies showed the drug was subpotent.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: The recall is classified as FDA Class III, which indicates the violation is not likely to cause adverse health consequences. The hazard is subpotency, which is a quality issue rather than a direct safety hazard like contamination or injury.
Plain-English summary
Macleods Pharma USA Inc is recalling Pramipexole Dihydrochloride Tablets 0.125 mg, 90-count bottles. The recall involves 1,837 bottles of Lot #BPA801A with an expiration date of 12/2020. The product was distributed nationwide in the USA.
The recall was initiated because an out-of-specification result was found during a stability study, indicating the drug was subpotent. This means the tablets may not contain the full amount of the active ingredient required for effective treatment.
Consumers who have this specific lot of Pramipexole Dihydrochloride Tablets should stop using them and contact their healthcare provider or pharmacist for guidance on obtaining a replacement or alternative treatment.
The recalled product
- Product
- PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
- Brand
- PRAMIPEXOLE DIHYDROCHLORIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Drug
- Hazard
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (2)
- Lot #BPA801A
- EXP 12/2020
UPCs (5)
- 0333342031105
- 0333342035103
- 0333342034106
- 0333342033109
- 0333342032102
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PRAMIPEXOLE DIHYDROCHLORIDE
- HighMacleods Pramipexole Dihydrochloride Tablets Recalled for Foreign Tablet Presence
FDA (Drugs) · 2016-02-17
Same manufacturer · Macleods Pharma Usa Inc
See all →- HighMacleods levothyroxine 150 microgram tablets recalled as a subpotent drug
FDA (Drugs) · 2026-04-01
- HighLosartan Potassium and Hydrochlorothiazide Tablets Recalled for Foreign Plastic Contamination
FDA (Drugs) · 2024-05-22
- ModerateLevofloxacin Tablets Recalled for Embossing and Packaging Insert Mismatch
FDA (Drugs) · 2023-01-25
- ModerateEszopiclone sleep medication recalled nationwide for shortfill packaging defect
FDA (Drugs) · 2022-07-13
- HighFDA Recalls Losartan-Hydrochlorothiazide Tablets for Manufacturing Quality Deviations
FDA (Drugs) · 2022-07-06
Same hazard · subpotency
See all →- ModerateGood Neighbor Pharmacy Earwax Removal Drug Recalled for Low Potency
FDA (Drugs) · 2026-07-22
- ModerateNystatin Cream Recall Due to Low Potency Test Results
FDA (Drugs) · 2026-07-22
- ModerateFoster & Thrive Carbamide Peroxide 6.5% Recalled for Subpotent Strength
FDA (Drugs) · 2026-07-22
- ModerateLeader Carbamide Peroxide Earwax Removal Kit Recalled for Subpotency
FDA (Drugs) · 2026-07-22
- ModerateMeijer Earwax Removal Kit Recalled for Subpotent Active Ingredient
FDA (Drugs) · 2026-07-22