Drug recall: Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz…

Class III FDA enforcement event 63160. Recall start date: 12 Sep 2012. Status in the FDA record: Terminated. Termination date: 10 Apr 2013.

Reason for recall, in the words of FDA

Impurities/Degradation Products: An out of specification result for a known impurity of the product occurred during 12 month stability testing.

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

Sandoz Incorporated started this drug recall on 12 Sep 2012. The firm address in the FDA record is in Broomfield, CO. FDA put the recall in Class III. FDA event 63160 has 2 product records. The first FDA enforcement report date is 26 Sep 2012. The record gives the status Terminated, with the termination date 10 Apr 2013.

FDA enforcement report The 2 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide

Recalling firm

Sandoz Incorporated, Broomfield, CO.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

2 product records in the event.

FDA event 63160: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1677-2012	Pramipexole Dihydrochloride Tablets, 0.25 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781- 5249-92,	43,060 x 90 count bottles	Class III	Terminated	26 Sep 2012
D-1678-2012	Pramipexole Dihydrochloride Tablets, 0.125 mg, 90-count tablets per bottle, Rx only, Manufactured in India by Sandoz Private Ltd., for Sandoz Inc., Princeton, NJ 08540, NDC 0781-5248-92	41,761bottles.	Class III	Terminated	26 Sep 2012

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2012: 209
Share of these events in Class III: 28%
Product records in this event: 2Median of the firm: 1
Events of the firm on the register: 15

Other events of the firm

Other FDA enforcement events of Sandoz Incorporated
Initiated	Product (first record)	Type	Class	Records
6 Apr 2018	Triamterene and Hydrochlorothiazide Tablets, USP, 75 mg/50 mg, 500-count bottles, Rx only, Manufactured by Sandoz, Inc.,	Drug	Class III	1
16 Jun 2017	Amitriptyline HCl Tablets, USP 25 mg, Packaged in a)100-count bottles (NDC 0781-1487-01) and b) 1000-count bottles ( NDC	Drug	Class III	1
22 Dec 2016	Nadolol Tablets, USP, 40mg, packaged in 1000-count bottle, Rx Only, Manufactured by Sandoz Inc., Princeton, NJ 08540, ND	Drug	Class II	1
5 Dec 2014	Fluoxetine Capsules USP, 20 mg, 100 count bottle, Rx Only, 100 Capsules, Sandoz Inc Princeton, NJ 08540 NDC 0781-2822-01	Drug	Class III	1
25 Jul 2014	Alprazolam Tablets, USP, 0.25mg, Rx only, 1000 tablets, Sandoz Inc., Princeton, NJ --- NDC 0781-1061-10	Drug	Class II	1
22 Oct 2013	Tacrolimus Capsules, USP, 0.5 mg, 100 capsules/bottle, Rx only, Manufactured in India by Sandoz Private ltd. for Sandoz	Drug	Class II	1
25 Sep 2013	Hydroxychloroquine Sulfate Tablets, USP, 200 mg, Rx Only, 100 Tablets per bottle, Sandoz Inc., Princeton NJ, 08540, NDC	Drug	Class III	1
7 Aug 2013	Introvale (levonorgestrel and ethinyl estradiol) tablets, USP, 0.15 mg/0.03 mg, packaged in 91 day regimen per unit cart	Drug	Class III	1
21 Jun 2013	Estarylla (Norgestimate and Ethinyl Estradiol) Tablets. USP, 0.25mg/0.035mg, 3X28 tablets per carton. Rx only, Manufactu	Drug	Class II	1
30 May 2013	Cefazolin, injection, 1 gram per vial, 25 vials per box, sterile, Rx only, single-use vial, Manufactured in Austria by S	Drug	Class II	1

Sandoz Incorporated: all 15 events

Official channels

FDA enforcement report D-1677-2012The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 63160. https://recallregister.com/fda/iii/63160/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide
What quantity of product is in FDA event 63160?: The event has 2 product records. The first record gives this quantity: 43,060 x 90 count bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2012 have the same class?: 28% of the 209 drug events that started in 2012 are in Class III.