ZARAH¿ Drospirenone/ Ethinyl Estradiol Tablets — Class II drug recall D-205-2013
Terminated recall by Watson Laboratories Inc, reported 2013-03-27, distributed nationwide. Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
| Recall number | D-205-2013 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Terminated |
| Voluntary or mandated | Voluntary |
| Recalling firm | Watson Laboratories Inc, Corona, CA, United States |
| Recall initiated | 2013-02-13 |
| Classified | 2013-03-19 |
| Reported by FDA | 2013-03-27 |
| Terminated | 2014-01-31 |
| Distributed | Nationwide (US) |
| Quantity | 136,720 cartons |
| Reason classes | device malfunction |
| NDC | 52544-0981-28, 52544-0981-31 |
| Lot numbers | 401536AA/401536A, 401537AA/401537/A, 401538AA/401538/A, 406985AA/406985A, 432058AA/432058A, 512685AA/512685A |
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 for recall
Failed Tablet/Capsule Specification; tablet breakage while pushing through the blister pack (dispenser) .
Machine access
This record, with every extracted code, the verbatim FDA record and provenance, is available from the recall API: GET https://api.data.aroqon.com/v1/recalls/D-205-2013. Look up any UPC, UDI, NDC or lot with /v1/recalls/lookup?code=…. API docs · free and paid keys.
Source: U.S. Food and Drug Administration enforcement report via openFDA (CC0). Structured by Data Foundry (recall-structuring@2); last changed 2026-09-26. Not affiliated with or endorsed by FDA. Not medical or legal advice.