FDA Drug recall D-205-2013
ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratori…
- FDA Drug
- Class II
- terminated
- Published 2013-03-27
On 2013-03-27 the FDA classified a Class II recall of ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets, 3.0 mg/0.03 mg, Rx only, 3 tablet dispensers, 28 tablets each, Manuf. by: Watson Laboratori… by Watson Laboratories, citing failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Read the official FDA Drug notice
| Agency | FDA Drug |
|---|---|
| Recall number | D-205-2013 |
| Classification | Class II |
| Status | terminated |
| Initiated | 2013-02-13 |
| Published | 2013-03-27 |
| Last updated | 2026-09-13 11:51 UTC |
| Company | Watson Laboratories |
| Distribution | US |
Product
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
Reason
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Identifiers
| code_info | Lot #s: 401536AA/401536A; 401537AA/401537/A; 401538AA/401538/A; 406985AA/406985A; 432058AA/432058A; 512685AA/512685A |
|---|
Status history
No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:51 UTC. Current status: terminated.
Source
Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-205-2013%22
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