CLASS II Drug recall · Reported 31 Oct 2012 · FDA Enforcement Report
Zovia (ethynodiol diacetate recalled by Watson Laboratories
Watson Laboratories is recalling Zovia (ethynodiol diacetate and ethinyl estradiol) Tablets USP, 1 mg/35 mcg, inert, distributed nationwide in the US. The recall was initiated on 19 Oct 2012 and the FDA has classified it as Class II.
Check your package
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-013-2013
- FDA event ID
- 63509
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 19 Oct 2012
- FDA classified
- 24 Oct 2012
- Reported
- 31 Oct 2012
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 19 Oct 2012 | Recall initiated by company | |
| 24 Oct 2012 | Classified by FDA | +5 days |
| 31 Oct 2012 | Published in enforcement report | +7 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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).
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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.
Where it was distributed
Nationwide and Puerto Rico
Questions about this recall
Why was it recalled?
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).
Which lots are affected?
Lot #: 515622AA, 515623AA, and 515623BA, Exp 09/30/13
Where was it sold?
Nationwide and Puerto Rico
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
4 other products · FDA event 63509This product is part of a recall event; the main page for the event is Necon 10/11 (norethindrone and ethinyl estradiol) Tablets recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Necon 10/11 (norethindrone and ethinyl estradiol) Tablets recalled | Watson Laboratories | Packaging Defects | Nationwide | |
| CLASS II | Lutera (levonorgestrel and ethinyl estradiol) Tablets recalled | Watson Laboratories | Packaging Defects | Nationwide | |
| CLASS II | Necon 1/35-28 (norethindrone recalled by Watson Laboratories | Watson Laboratories | Packaging Defects | Nationwide | |
| CLASS II | Zenchent (norethindrone and ethinyl estradiol) Tablets USP, 0.4 mg/0 recalled | Watson Laboratories | Packaging Defects | Nationwide |
More recalls from Watson Laboratories
All 22| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Hydrocodone Bitartrate and Acetaminophen Tablets USP, CIII recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Carisoprodol Tablets, USP, CIV, 350 mg recalled by Watson Laboratories | Watson Laboratories | Particulate Matter | Nationwide |
| Drug | CLASS II | Next Choice" One Dose Emergency Contraceptive recalled | Watson Laboratories | Other | Nationwide |
| Drug | CLASS II | Oxycodone and Acetaminophen Tablets, USP 10 mg/650 mg, CII recalled | Watson Laboratories | Packaging Defects | Nationwide |
| Drug | CLASS III | Hydrocodone Bitartrate and Acetaminophen Tablets, 7.5 mg recalled | Watson Laboratories | Packaging Defects | Nationwide |