Mylan recalls birth control pills: Incorrect labeling on blister packs
Mylan Pharmaceuticals recalls 3 extended-cycle birth control pill packs with incorrect labeling on blister packs. This affects prescription-only pills sold in India with specific NDC and lot numbers.
Lower-risk recall
Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs.
Contact the company
What happened, in plain English
Mylan is recalling prescription birth control pills that have incorrect labeling on the blister packs. This means the product name and NDC number are wrong, which could lead to confusion about the correct medication. Read more at govinfonow.com/recall/39675-mylan-recalls-birth-control-pills-incorrect-labeling-on-blister-packs.
Source Summary by GovInfoNow · govinfonow.com/recall/39675-mylan-recalls-birth-control-pills-incorrect-labeling-on-blister-packs · Updated October 6, 2026 · FDA enforcement record: FDA #D-0025-2019
Cite this page
“Mylan recalls birth control pills: Incorrect labeling on blister packs.” GovInfoNow, updated October 6, 2026. https://govinfonow.com/recall/39675-mylan-recalls-birth-control-pills-incorrect-labeling-on-blister-packs. Based on FDA recall #D-0025-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0025-2019%22&limit=1).
Why it’s dangerous
The blister packs have incorrect product names and NDC numbers, which could cause confusion about the medication. This might lead to using the wrong pill if someone misidentifies it, but it does not pose a direct health risk.
Who’s affected
Prescription holders of these specific birth control pills in the U.S. who received the recalled packs. Those with the NDC 0378-7281-53 and lot number 8508F004A are most at risk.
How to tell if you have this one
Check for the NDC number 0378-7281-53 and lot number 8508F004A on the blister packs. The pills are prescription-only birth control tablets sold in India with an expiration date of February 2020.
- Brand
Mylan- Category
Drug
What to do — step by step
Check Labeling
Verify the NDC number and product name on the blister packs to ensure they match the correct information.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Product was distributed throughout the United States.” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 11 months after the firm started it.
- Firm started the recall
- FDA classified it Class III
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
Questions people ask
Are these pills safe to use?
The recall is due to incorrect labeling, not safety issues. The pills themselves are safe but may be misidentified if the labels are wrong.
Do I need to stop using these pills?
No, the recall does not require stopping use. You can continue using them but should check the labeling to avoid confusion.
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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-0025-2019 (August 27, 2018) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0025-2019 to see it in context.
- Plain-language summary written by qwen3:4b on October 6, 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.