Unrated Drug recall · FDA · Published June 23, 2023

Lupin Tydemy Tablets Recall: Stability and Impurity Issues

Lupin Pharmaceuticals recalls Tydemy tablets due to stability and impurity failures. Affected lots may have inactive content and impurities that could pose risks. Contact for details.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1081-2023Drug Lupin ›

Recall notice

Failed Stability Specification and Failed Impurities/Degradation Specifications: out of specification for inactive content ascorbic acid and MTHFRC-7impurity test

Take action

Contact the company

Recalling firmLupin Pharmaceuticals Inc.Harborplace Tower, 111 S Calvert St Fl 21st · Baltimore, MD 21202-6174

✎ GovInfoNow plain-language explainer

Lupin Pharmaceuticals is recalling Tydemy birth control tablets because they failed stability and impurity tests. This means the tablets might contain unsafe levels of inactive ingredients or impurities that could affect safety. Read more at govinfonow.com/recall/33400-lupin-tydemy-tablets-recall-stability-and-impurity-issues.

Source Summary by GovInfoNow · govinfonow.com/recall/33400-lupin-tydemy-tablets-recall-stability-and-impurity-issues · Updated August 18, 2026 · FDA enforcement record: FDA #D-1081-2023

Cite this page

“Lupin Tydemy Tablets Recall: Stability and Impurity Issues.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/33400-lupin-tydemy-tablets-recall-stability-and-impurity-issues. Based on FDA recall #D-1081-2023 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1081-2023%22&limit=1).

Lupin Pharmaceuticals Inc. recalled Tydemy tablets nationwide on June 23, 2023, after they failed stability and impurity specifications, the FDA said in a Class I recall announcement.

How to tell if you have it

Brand: Lupin
Product: Tydemy (drospirenone, ethinyl estradiol and levomefolate calcium tablets, 3 mg/0.03 mg/0.451 mg and levomefolate calcium tablets 0.451 mg)
NDC: 68180-904-71 (blister), 68180-904-73 (carton)
Lot codes: L200183 (Exp 1/2024), L201560 (Exp 9/2024)

The hazard

The tablets were out of specification for inactive content ascorbic acid and MTHFRC-7impurity test, according to the FDA.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since 2013-01-31. Other recent recalls of similar products include Lupin Clobetasol Cream Recall (2026-08-03), Lupin Glucagon Emergency Kit Recall (2026-06-23), and Lupin prednisolone acetate ophthalmic suspension recall (2026-06-04).

How to tell if you have this one

Check the product label for the lot numbers L200183 (expires 1/2024) or L201560 (expires 9/2024). The tablets come in blister packs of 28 tablets per blister, with a carton of 3 blisters.

Brand
Lupin
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the lot numbers L200183 or L201560 on the packaging to confirm if your tablets are affected.

Where it went and when

Where it was distributed

Distributed nationwide.

FDA distribution: “USA nationwide.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 19 months after the firm started it.

Jun 23, 2023Firm started the recall
Aug 4, 2023FDA classified it Class I
Aug 9, 2023Published in FDA’s Enforcement Report
Jan 28, 2025FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

Similar recalls

Other Lupin recalls

Latest drug recalls

Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/33400-lupin-tydemy-tablets-recall-stability-and-impurity-issues">Lupin Tydemy Tablets Recall: Stability and Impurity Issues (GovInfoNow)</a>

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-1081-2023 (June 23, 2023) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1081-2023 to see it in context.
Plain-language summary written by qwen3:4b on August 18, 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.