Mylan Norethindrone Tablets Recall: Chemical Contamination Risk
Mylan recalls 1 mg/0.02 mg norethindrone tablets due to chemical contamination from paint thinner vapors during manufacturing. This may pose health risks. Consumers should contact Mylan for details.
Recall notice
Chemical Contamination: out of specification results for impurities were found to be the result of contamination of product from vapors associated with paint thinner used in repair of the manufacturing room.
Contact the company
What happened, in plain English
Mylan is recalling norethindrone tablets that were contaminated during manufacturing. This contamination could pose health risks to users, though the specific risk level isn't clearly stated in the recall. Read more at govinfonow.com/recall/42061-mylan-norethindrone-tablets-recall-chemical-contamination-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/42061-mylan-norethindrone-tablets-recall-chemical-contamination-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-0861-2017
Cite this page
“Mylan Norethindrone Tablets Recall: Chemical Contamination Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42061-mylan-norethindrone-tablets-recall-chemical-contamination-risk. Based on FDA recall #D-0861-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0861-2017%22&limit=1).
Why it’s dangerous
The tablets were contaminated with chemicals from paint thinner vapors used in the manufacturing facility. This contamination could lead to health issues if the tablets are ingested.
Who’s affected
People who have the specific Mylan norethindrone tablets with lot number 6327A006, manufactured in India, are affected. Those using these tablets for birth control are at risk.
How to tell if you have this one
Check for the product name 'Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg' and lot number 6327A006 on the packaging. The tablets are packaged in 3 pouches, each containing one blister pack of 21 tablets.
- Brand
Mylan- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class III- Status
Terminated- Distribution
Nationwide in USA
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0860-2017 | Tarina Fe 1/20 (Norethindrone Acetate and Ethinyl Estradiol Tablets, USP and Ferrous Fumarate Tablets), 1 blister pack containing 28 tablets (NDC 50102-128-01), packaged in 3 pouches, each pouch contains one blister pack of 28 tablets (NDC 50102-128-03), Rx only, Manufactured for: Afaxys, Inc., Charleston, SC 29403, USA, Product of India.; Lot #: 6843F002D, Exp 02/18 | 43,848 cartons | — |
| D-0861-2017 | Norethindrone Acetate and Ethinyl Estradiol Tablets, USP, 1 mg/0.02 mg, 1 blister pack containing 21 tablets (NDC 0378-7280-85), packaged in 3 pouches, each contains one blister pack of 21 tablets (NDC 0378-7280-53), Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., Made in India.; Lot #: 6327A006, Exp 02/18 | 8,605 cartons | 0378-7280-85, 0378-7280-53 |
What to do — step by step
Check Product Details
Look for the lot number 6327A006 on the packaging to confirm if the product is recalled.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in USA” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 4 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.
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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-0861-2017 (January 30, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0861-2017 to see it in context.
- Plain-language summary written by qwen3:4b on October 8, 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.