Drospirenone and Ethinyl Estradiol Tablets — Class II drug recall D-0992-2019
Completed recall by Apotex Inc., reported 2019-03-13, distributed nationwide. Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
| Recall number | D-0992-2019 |
|---|---|
| Product type | Drug |
| Classification | Class II |
| Status | Completed |
| Voluntary or mandated | Voluntary |
| Recalling firm | Apotex Inc., North York, N/A, Canada |
| Recall initiated | 2019-03-01 |
| Classified | 2019-03-11 |
| Reported by FDA | 2019-03-13 |
| Distributed | Nationwide (US) |
| Quantity | 82,705 cartons |
| NDC | 60505-4183-01, 60505-4183-03 |
| Lot numbers | 7DY008A, 7DY009A, 7DY010A, 7DY011A |
| Expiration dates | 2020-08 |
Product
Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg, 28 Tablets Blister, 1 Unit (NDC 60505-4183-1) packaged as 84 Tablets Blister, 3x1 Unit per carton (NDC 60505-4183-3), Rx Only, Manufactured for: Apotex Corp., Weston, FL 33326; Manufactured by: Oman Pharmaceutical Products Co. L.L.C., P.O. Box 1885, Postal Code 111, Seeb.
Reason for recall
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
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-0992-2019. 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.