CLASS III Drug recall · Reported 19 Sep 2018 · FDA Enforcement Report

Pramipexole dihydrochloride extended release tablets, 75 mg recalled

Par Pharmaceutical is recalling Pramipexole dihydrochloride extended release tablets, 75 mg, distributed nationwide in the US. The recall was initiated on 6 Sep 2018 and the FDA has classified it as Class III.

Check your package

Lot, batch or date codesLot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.

Quantity recalled16,207 (bottles of 30 tablets)

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-1185-2018
FDA event ID: 80969
Recalling firm: Par Pharmaceutical, Chestnut Ridge, NY
Classification: Class III
Status: Terminated
Recall initiated: 6 Sep 2018
FDA classified: 10 Sep 2018
Reported: 19 Sep 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay

Timeline

6 Sep 2018	Recall initiated by company
10 Sep 2018	Classified by FDA	+4 days
19 Sep 2018	Published in enforcement report	+9 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

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 extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11

Where it was distributed

United States nationwide

Nationwide

Questions about this recall

Is Pramipexole dihydrochloride extended release tablets, 75 mg recalled?

Yes. Par Pharmaceutical recalled Pramipexole dihydrochloride extended release tablets, 75 mg on 6 Sep 2018. The recall is Class III and its status is Terminated. Recall number D-1185-2018.

Why was it recalled?

Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels.

Which lots are affected?

Lot #: 29906202, Exp 12/18; 29993102, Exp 2/19; 30366102, 30373103, Exp 4/19; 31940601, Exp 3/20.

Where was it sold?

United States 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 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 Par Pharmaceutical

All 17

Reported	Class	Recall	Company	Reason	Where
2 Sep 2020Drug	CLASS II	BusPIRone Hydrochloride Tablets, USP 5 mg recalled by Par Pharmaceutical	Par Pharmaceutical	Potency & Assay	Nationwide
8 Apr 2020Drug	CLASS II	Glycopyrrolate Tablets, USP 1 mg recalled by Par Pharmaceutical	Par Pharmaceutical	Potency & Assay	NY
25 Mar 2020Drug	CLASS III	PrediniSONE Tablets, USP 5 mg recalled by Par PharmaceuticalPrednisone	Par Pharmaceutical	Other	Nationwide
19 Feb 2020Drug	CLASS III	Frovatriptan Succinate Tablets, 5mg recalled by Par Pharmaceutical	Par Pharmaceutical	Labeling Errors	Nationwide
15 May 2019Drug	CLASS I	Mycophenolate Mofetil for Injection, USP 500 mg Dose Vials recalledMycophenolate Mofetil	Par Pharmaceutical	Particulate Matter	Nationwide

Other Pramipexole di recalls

All 18

Reported	Class	Recall	Company	Reason	Where
18 Sep 2019Drug	CLASS III	Pramipexole Dihydrochloride Tablets 125 mg recalledPramipexole Dihydrochloride	Macleods Pharma Usa	Potency & Assay	Nationwide
3 Jul 2019Drug	CLASS II	Pramipexole Dihydrochloride Tablets, 25 mg (10 x recalled	American Health Packaging	Packaging Defects	Nationwide
3 Jul 2019Drug	CLASS II	Pramipexole Dihydrochloride Tablets, 5 mg per blister card) recalled	American Health Packaging	Packaging Defects	Nationwide
3 Jul 2019Drug	CLASS II	Pramipexole Dihydrochloride Tablets, 0 mg per blister card) recalled	American Health Packaging	Packaging Defects	Nationwide
3 Jul 2019Drug	CLASS II	Pramipexole Dihydrochloride Tablets, 125 mg per blister card) recalled	American Health Packaging	Packaging Defects	Nationwide