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Recall Observatory FDA recall evidence

Exact FDA event identifier

Event 63509

5 recalled-product records grouped only because every row carries this exact official event ID.

Open FDA event record

Event summary

Timeline bucket
October 19, 2012
Product types
Drug
Classifications
Class II
Statuses
Terminated
Recalling firm wording
Watson Laboratories Inc

Dossier provenance

Source snapshots represented here

  • openFDA Drug Enforcement Report-date coverage June 20, 2012–July 08, 2026 Known gap: openFDA describes 2004-present coverage, but the current export has no report-date records in this interval.

Enforcement coverage uses report dates; product initiation dates can precede those bounds. Device-enrichment coverage uses FDA event_date_initiated.

How coverage and grouping work

Complete imported group

Every recalled product in this event

5 official enforcement rows

Product dates, classifications, firms, and source wording remain attached to their individual rows. Opening this dossier never hides products that did not match a prior timeline filter.

drug · product 1 of 5

Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-383-28.

D-013-2013
Recall number
D-013-2013
Initiated
October 19, 2012
Classification
Class II
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
30,267 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

Code information

Lot #: 515622AA, 515623AA, and 515623BA, Exp 09/30/13

Distribution pattern

Nationwide and Puerto Rico

drug · product 2 of 5

Lutera (levonorgestrel and ethinyl estradiol) Tablets USP, 0.1 mg/0.02 mg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Parsippany, NJ 07054 USA; NDC 52544-949-28.

D-014-2013
Recall number
D-014-2013
Initiated
October 19, 2012
Classification
Class II
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
67,860 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

Code information

Lot #: 517921AA, 517921AB, 517922AA, 517922AB, 517923AA, 517923AB, Exp 03/31/14

Distribution pattern

Nationwide and Puerto Rico

drug · product 3 of 5

Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0.035 mg, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA; NDC 52544-953-28.

D-015-2013
Recall number
D-015-2013
Initiated
October 19, 2012
Classification
Class II
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
12,333 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

Code information

Lot #: 514767AA, Exp 03/31/14

Distribution pattern

Nationwide and Puerto Rico

drug · product 4 of 5

Necon 10/11 (norethindrone and ethinyl estradiol) Tablets USP, 0.5 mg/35 mcg, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880 USA; Distributed by: Watson Pharma, Inc.; NDC 52544-554-28.

D-016-2013
Recall number
D-016-2013
Initiated
October 19, 2012
Classification
Class II
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
1,684 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

Code information

Lot # 512642B, Exp 08/31/13

Distribution pattern

Nationwide and Puerto Rico

drug · product 5 of 5

Necon 1/35-28 (norethindrone and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert tablets, 28-count tablets per dispenser packaged in 6 Tablet Dispensers per carton, Rx only, Manufactured by: Watson Pharma, Inc., A subsidiary of Watson Pharmaceuticals, Inc., Corona, CA 92880 USA; NDC 52544-552-28.

D-017-2013
Recall number
D-017-2013
Initiated
October 19, 2012
Classification
Class II
Status
Terminated
Recalling firm
Watson Laboratories Inc
Quantity
6,466 cartons

App-derived interpretation

Unknown reason.no_named_rule · v1.0.0
Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

These labels are deterministic app interpretations, not FDA categories.

Inspect official wording and provenance

Reason for recall

Cross Contamination With Other Products: The firm recalled Zovia, Lutera, Necon, and Zenchent, because certain lots could potentially be contaminated with trace amounts of Hydrochlorothiazide (HCTZ).

Code information

Lot #: 514743AB, Exp 09/30/13

Distribution pattern

Nationwide and Puerto Rico