Class III · Low risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride Tablets 0.125 mg
Is Pramipexole recalled?
Not under an active recall.
Pramipexole was recalled 23 times in the past — all now closed. Most recent: Aug 21, 2019.
Most common reason: Cross-contamination (11 of these recalls)
Recalls are matched by product description. A recall usually affects specific lots, not every package of Pramipexole. “Active” means an FDA recall is still ongoing; “closed” means it was terminated or completed. Checked against openFDA on Oct 10, 2026.
Pramipexole recalls on record
none so far in 2026; 23 on record, newest first
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
GMP Deviations; possible cross contamination of product due to cleaning procedure failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 1 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.5 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.25 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochoride Tablets 0.25 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole DihydrochlorideTablets 0.125 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Class III · Low risk
Mirapex (pramipexole dihydrochloride)
Failed Tablet/Capsule Specifications: identification of low weight tablets during routine stability testing.
Class III · Low risk
Pramipexole dihydrochloride extended release tablets
Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.
Class III · Low risk
Pramipexole Dihydrochloride Extended Release Tablets
Failed Impurities/Degradation Specifications: Par Pharmaceutical is recalling Pramipexole Dihydrochloride Extended Release tablets because it contains a known product impurity above currently approved specification levels.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets 0.125 mg
Presence of Foreign Tablets/Capsules: Presence of a comingled Carbimazole 5 mg tablet.
Class II · Moderate risk
Pramipexole Di-Hcl
Labeling:Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1.5 mg may be potentially mislabeled as LIOTHYRONINE SODIUM, Tablet, 25 mcg, NDC 42794001902, Pedigree: AD68010_11, EXP: 5/28/2014.
Class II · Moderate risk
PRAMIPEXOLE DI-HCL Tablet
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 1 mg may be potentially mislabel as MISOPROSTOL, Tablet, 200 mcg, NDC 59762500801, Pedigree: W003117, EXP: 6/13/2014.
Class II · Moderate risk
PRAMIPEXOLE DI-HCL Tablet
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.25 mg may be potentially mislabeled as TACROLIMUS, Capsule, 1 mg, NDC 00781210301, Pedigree: W003704, EXP: 6/26/2014.
Class II · Moderate risk
Pramipexole Di-Hcl
Labeling: Label Mixup; PRAMIPEXOLE DI-HCL, Tablet, 0.125 mg may be potentially mislabeled as MULTIVITAMIN/MULTIMINERAL, Tablet, NDC 00904549213, Pedigree: AD23082_13, EXP: 11/1/2013; PERPHENAZINE, Tablet, 16 mg, NDC 00781104901, Pedigree: W003682, EXP: 6/25/2014.
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class III · Low risk
Pramipexole Dihydrochloride Tablets
Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.
Class II · Moderate risk
Pramipexole Dihydrochloride Tablets
Labeling: Label Mix up; product labeled to contain Nebivolol tablets actually contained Pramipexole Dihydrochloride tablets
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