Macleods Pramipexole Dihydrochloride Tablets Recalled for Foreign Tablet Presence
Macleods Pharma USA is recalling Pramipexole Dihydrochloride tablets due to the presence of a foreign Carbimazole 5 mg tablet.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 3/5 (High).
Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.
Our severity reasoning: The recall is classified as FDA Class II, and the presence of a foreign medication (Carbimazole) in a prescription drug poses a risk of harm, fitting the criteria for a high-risk product where injury has not yet been reported.
Plain-English summary
Macleods Pharma USA Inc. is recalling Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. The recall is being conducted because of the presence of a comingled Carbimazole 5 mg tablet in the product.
The affected product is identified by Lot # BPA512A with an expiry date of 06/2017. The product was distributed nationwide in the United States. It was manufactured for Macleods Pharma USA, Inc. in Plainsboro, NJ, and manufactured by Macleods Pharmaceuticals Ltd. in Baddi, Himachal Pradesh, India.
Consumers and healthcare providers should stop using the affected product and contact their pharmacist or healthcare provider for guidance on replacement or disposal.
The recalled product
- Product
- PRAMIPEXOLE DIHYDROCHLORIDE (PRAMIPEXOLE DIHYDROCHLORIDE)
- Brand
- PRAMIPEXOLE DIHYDROCHLORIDE
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Drug
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 #: BPA512A
- Expiry: 06/2017.
UPCs (5)
- 0333342031105
- 0333342035103
- 0333342034106
- 0333342033109
- 0333342032102
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · PRAMIPEXOLE DIHYDROCHLORIDE
- ModerateMacleods Recalls Pramipexole Dihydrochloride Tablets Due to Subpotency
FDA (Drugs) · 2019-09-18
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 · foreign object
See all →- ModerateMezzetta Golden Greek Peperoncini Recalled for Potential Mouse Contamination
FDA (Food) · 2026-10-14
- SevereUnited and Good & Gather Light Brown Sugar Recalled for Wheat Contamination
FDA (Food) · 2026-09-30
- SevereBaxter Recalls Dextrose Injection Bags Due to Stainless Steel Particulate Matter
FDA (Drugs) · 2026-09-16
- ModerateBionpharma Recalls Doxylamine Succinate Tablets Due to Foreign Material Presence
FDA (Drugs) · 2026-09-09
- SevereTeva Recalls Trazodone Hydrochloride Tablets Due to Foreign Material
FDA (Drugs) · 2026-09-09
Similar recalls
- ModerateMacleods Recalls Pramipexole Dihydrochloride Tablets Due to Subpotency
FDA (Drugs) · 2019-09-18
- ModerateClopidogrel Tablets Recalled for Foreign Matter Contamination
FDA (Drugs) · 2021-09-08
- ModerateZydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross Contamination
FDA (Drugs) · 2019-06-26
- ModerateZydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination
FDA (Drugs) · 2019-06-26
- SevereZydus Recalls Pramipexole Dihydrochloride Tablets Due to Cross-Contamination Risk
FDA (Drugs) · 2019-06-26
- SevereAmerican Health Packaging Recalls Pramipexole Dihydrochloride Tablets Due to GMP Deviations
FDA (Drugs) · 2019-07-03