Teva Amethyst Birth Control Pills: Incorrect Instructions Risk
Teva recalls Amethyst birth control pills due to incorrect labeling that says some tablets are inactive when all are active. This could lead to unintended pregnancy if users skip doses.
Lower-risk recall
Labeling: Incorrect Instructions. "TABLETS IN WEEK 4 ARE INACTIVE" printed on the blister foil and package insert, however,all tablets are active.
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What happened, in plain English
Teva is recalling Amethyst birth control pills because the labeling incorrectly states that tablets in week 4 are inactive, when all tablets are actually active. This could cause unintended pregnancy if users follow the incorrect instructions. Read more at govinfonow.com/recall/41046-teva-amethyst-birth-control-pills-incorrect-instructions-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/41046-teva-amethyst-birth-control-pills-incorrect-instructions-risk · Updated October 7, 2026 · FDA enforcement record: FDA #D-0125-2018
Cite this page
“Teva Amethyst Birth Control Pills: Incorrect Instructions Risk.” GovInfoNow, updated October 7, 2026. https://govinfonow.com/recall/41046-teva-amethyst-birth-control-pills-incorrect-instructions-risk. Based on FDA recall #D-0125-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0125-2018%22&limit=1).
Why it’s dangerous
The product label states that tablets in week 4 are inactive, but all tablets are active. If users believe only some tablets are active and skip doses, they could become pregnant.
Who’s affected
Women who have been prescribed Amethyst birth control pills by a doctor are affected. Those who follow the incorrect labeling instructions may risk unintended pregnancy.
How to tell if you have this one
Check for Amethyst birth control pills with 28 tablets in a blister foil pack. The product was distributed by Actavis Pharma, Inc. in the US with NDC-52544-295-28 and lot number 544637A.
- Brand
Teva Pharmaceuticals USA- Category
Drug
What to do — step by step
Check Label Instructions
Review the product label to confirm all tablets are active, not just those in week 4.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- 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-0125-2018 (November 20, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0125-2018 to see it in context.
- Plain-language summary written by qwen3:4b on October 7, 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.