CLASS II Drug recall · Reported 17 Feb 2016 · FDA Enforcement Report
Pramipexole Dihydrochloride Tablets 0.125 mg recalled
Macleods Pharma Usa is recalling Pramipexole Dihydrochloride Tablets 0.125 mg, distributed nationwide in the US. The recall was initiated on 24 Dec 2015 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0653-2016
- FDA event ID
- 73017
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 24 Dec 2015
- FDA classified
- 5 Feb 2016
- Reported
- 17 Feb 2016
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 24 Dec 2015 | Recall initiated by company | |
| 5 Feb 2016 | Classified by FDA | +43 days |
| 17 Feb 2016 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Product as listed by the FDA
Pramipexole Dihydrochloride Tablets 0.125 mg, 90 Ct Bottles, Rx Only. Manufactured for: Macleods Pharma USA, Inc., Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd., Baddi, Himachal Pradesh, INDIA. NDC: 33342-031-10.
Where it was distributed
US Nationwide.
Questions about this recall
Why was it recalled?
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Which lots are affected?
Lot #: BPA512A; Expiry: 06/2017.
Where was it sold?
US Nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Macleods Pharma Usa
All 34| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Levothyroxine Sodium Tablets USP 150 mcg recalled by Macleods Pharma UsaLevothyroxine Sodium | Macleods Pharma USA | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS III | Levofloxacin Tablets, USP 500 mg recalled by Macleods Pharma Usa | Macleods Pharma USA | Packaging Defects | Nationwide |
| Drug | CLASS II | Eszopiclone Tablets, USP 1 mg recalled by Macleods Pharma UsaEszopiclone | Macleods Pharma Usa | Packaging Defects | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
Other Pramipexole Dihydrochloride recalls
All 16| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Pramipexole Dihydrochloride Tablets 0.125 mg recalledPramipexole Dihydrochloride | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.25 mg (10 recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.5 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 1.0 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0.125 mg per blister card) recalled | American Health Packaging | Processing Deviation | Nationwide |