CLASS III Drug recall · Reported 18 Sep 2019 · FDA Enforcement Report
Pramipexole Dihydrochloride Tablets 125 mg recalled
Macleods Pharma Usa is recalling Pramipexole Dihydrochloride Tablets 125 mg, distributed nationwide in the US. The recall was initiated on 21 Aug 2019 and the FDA has classified it as Class III.
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-1851-2019
- FDA event ID
- 83597
- Recalling firm
- Macleods Pharma Usa, Plainsboro, NJ
- Manufacturer
- Macleods Pharmaceuticals Limited
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 21 Aug 2019
- FDA classified
- 11 Sep 2019
- Reported
- 18 Sep 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
Timeline
| 21 Aug 2019 | Recall initiated by company | |
| 11 Sep 2019 | Classified by FDA | +21 days |
| 18 Sep 2019 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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 was distributed
Distributed Nationwide in the USA
Questions about this recall
Is Pramipexole Dihydrochloride Tablets 125 mg recalled?
Yes. Macleods Pharma Usa recalled Pramipexole Dihydrochloride Tablets 125 mg on 21 Aug 2019. The recall is Class III and its status is Terminated. Recall number D-1851-2019.
Why was it recalled?
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Which lots are affected?
Lot #BPA801A, EXP 12/2020
Where was it sold?
Distributed Nationwide in the USA
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 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
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|---|---|---|---|---|---|
| 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 Di recalls
All 18| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 25 mg (10 x recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 5 mg per blister card) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 0 mg per blister card) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets, 125 mg per blister card) recalled | American Health Packaging | Packaging Defects | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |