CLASS II Drug recall · Reported 13 Mar 2019 · FDA Enforcement Report
Drospirenone and Ethinyl Estradiol Tablets recalled by Apotex
Apotex is recalling Drospirenone and Ethinyl Estradiol Tablets, USP, 3 mg/0.03 mg Blister (, distributed nationwide in the US. The recall was initiated on 1 Mar 2019 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-0992-2019
- FDA event ID
- 82288
- Recalling firm
- Apotex, North York, N/A
- Classification
- Class II
- Status
- Completed
- Recall initiated
- 1 Mar 2019
- FDA classified
- 11 Mar 2019
- Reported
- 13 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Packaging Defects
- Drug class
- Hormones & Birth Control
Timeline
| 1 Mar 2019 | Recall initiated by company | |
| 11 Mar 2019 | Classified by FDA | +10 days |
| 13 Mar 2019 | Published in enforcement report | +2 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
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
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.
Where it was distributed
Nationwide in the USA.
Questions about this recall
Why was it recalled?
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Which lots are affected?
Lots: 7DY008A, 7DY009A, 7DY010A, 7DY011A, Exp. 08/2020
Where was it sold?
Nationwide in the USA.
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.
More recalls from Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Desmopressin Nasal Spray, USP, 10 mcg/ bottle (50 doses) recalled | Apotex | Other | Nationwide |
| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
Other Drospirenone recalls
All 3| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Tydemy (drospirenone, ethinyl estradiol recalledTydemy | Lupin Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Drospirenone and Ethinyl Estradiol Tablets recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |