Drug recall: Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg…

Class III FDA enforcement event 63906. Recall start date: 13 Dec 2012. Status in the FDA record: Terminated. Termination date: 4 Dec 2013.

Reason for recall, in the words of FDA

Impurities/Degradation Products: Out-of-specification results were obtained for a known impurities.

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

Watson Laboratories Inc started this drug recall on 13 Dec 2012. The firm address in the FDA record is in Corona, CA. FDA put the recall in Class III. FDA event 63906 has 1 product record. The first FDA enforcement report date is 26 Dec 2012. The record gives the status Terminated, with the termination date 4 Dec 2013.

FDA enforcement report The 1 product record

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

Watson Laboratories Inc, Corona, CA.

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

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

Products

1 product record in the event.

FDA event 63906: product records
Recall number	Product	Quantity	Class	Status	Report date
D-094-2013	Caziant (desogestrel and ethinyl estradiol) Tablets, USP, (Triphasic Regimen), 0.1 mg/0.025 mg, 0.125 mg/0.025 mg, 0.15 mg/0.025 mg, 28-count tablets per dispenser (NDC 52544-959-28), packaged in 3-count Tablet Dispensers per carton (NDC 52544-959-31), Rx only Manufactured by: Watson Laboratories, Inc., Corona, CA…	63,627 cartons	Class III	Terminated	26 Dec 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: 1Median of the firm: 1
Events of the firm on the register: 13

Other events of the firm

Other FDA enforcement events of Watson Laboratories Inc
Initiated	Product (first record)	Type	Class	Records
15 Jan 2014	Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII, 10 mg/ 660 mg, 100 count bottles, Rx only. Manufactured by W	Drug	Class II	1
23 Dec 2013	Carisoprodol Tablets, USP, CIV, 350 mg, 500 count bottle, Rx only. Manufactured by Watson Pharma Private Ltd, Verna, Sal	Drug	Class II	1
23 Sep 2013	Next Choice" One Dose Emergency Contraceptive (Levonorgestrel Tablet), 1.5 mg, 1 Tablet/Blister Card (NDC 52544-287-54),	Drug	Class II	1
13 Sep 2013	Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII, 100 Count Bottles, Rx Only, Manufactured by: Watson Laborato	Drug	Class II	1
30 Aug 2013	Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg/650 mg Tablets, 500 Count Bottle, Manufactured by: Watson Labor	Drug	Class III	1
19 Jul 2013	Oxycodone and Acetaminophen Capsules, USP 5mg/500 mg, packaged in a)100-count bottle (NDC 0591-0737-01), b) 500-count bo	Drug	Class III	1
13 Feb 2013	ZARAH Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by:	Drug	Class II	1
8 Feb 2013	Meprobamate, Tablets USP, 200 mg, 100 tablets; Rx only; Manufactured By: Watson Laboratories, Inc., Corona, CA 92800 USA	Drug	Class II	2
19 Oct 2012	Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispens	Drug	Class II	5
21 Sep 2012	Hydrocodone Bitartrate and Acetaminophen Tablets USP, 10 mg/500 mg, 500-count Tablets per bottle, Rx only, Manufactured	Drug	Class I	1

Watson Laboratories Inc: all 13 events

Official channels

FDA enforcement report D-094-2013The 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 63906. https://recallregister.com/fda/iii/63906/. 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 63906?: The FDA record gives this quantity: 63,627 cartons
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.