Apotex Drospirenone-Ethinyl Estradiol Tablets Recall: Missing Tablet Placement Risk
Apotex recalls 3 mg/0.03 mg contraceptive tablets due to missing or incorrect tablet placement in the blister pack. Consumers should check their packaging for NDC 60505-4183-1 or 60505-4183-3 and contact Apotex for details.
Lower-risk recall
Contraceptive Tablets Out of Sequence: Missing or incorrect tablet placement.
Contact the company
What happened, in plain English
Apotex is recalling contraceptive tablets that may have missing or incorrect tablet placement in the blister pack. This could lead to incorrect hormone dosing if the user takes the wrong tablet at the wrong time. Read more at govinfonow.com/recall/39140-apotex-drospirenone-ethinyl-estradiol-tablets-recall-missing-tablet-placement-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/39140-apotex-drospirenone-ethinyl-estradiol-tablets-recall-missing-tablet-placement-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-0992-2019
Cite this page
“Apotex Drospirenone-Ethinyl Estradiol Tablets Recall: Missing Tablet Placement Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39140-apotex-drospirenone-ethinyl-estradiol-tablets-recall-missing-tablet-placement-risk. Based on FDA recall #D-0992-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0992-2019%22&limit=1).
Why it’s dangerous
The tablets may be out of sequence, meaning the user might take the wrong tablet at the wrong time. This could cause incorrect hormone dosing, potentially leading to unintended pregnancy or hormonal side effects.
Who’s affected
Women who have purchased the recalled contraceptive tablets for birth control are affected. Those using the product as directed are at the lowest risk if they check the tablet placement.
How to tell if you have this one
Check for the NDC code 60505-4183-1 or 60505-4183-3 on the blister pack. The product was manufactured for Apotex Corp. in Weston, Florida, and shipped with specific lot numbers from Oman Pharmaceutical Products Co. L.L.C.
- Brand
Apotex- Category
Drug
What to do — step by step
Check Tablet Placement
Ensure the tablets are in the correct sequence as per the package instructions before use.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 12 days after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0992-2019 (March 1, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0992-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.