CLASS II Drug recall · Reported 27 Mar 2013 · FDA Enforcement Report
Zarah¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg recalled
Watson Laboratories is recalling Zarah¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, distributed nationwide in the US. The recall was initiated on 13 Feb 2013 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-205-2013
- FDA event ID
- 64358
- Recalling firm
- Watson Laboratories, Corona, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 13 Feb 2013
- FDA classified
- 19 Mar 2013
- Reported
- 27 Mar 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Hormones & Birth Control
Timeline
| 13 Feb 2013 | Recall initiated by company | |
| 19 Mar 2013 | Classified by FDA | +34 days |
| 27 Mar 2013 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Product as listed by the FDA
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratories, Inc., Corona, CA 92880. USA; Distributed by: Watson Pharma, Inc., Corona, CA 92880 USA. NDC 52544-981-31 Carton; NDC 52544-981-28
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Which lots are affected?
Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A
Where was it sold?
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 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.
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