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Stop using now Drug recall · FDA · Published November 19, 2021

Lupin Tydemy: Subpotent Drug Recall - Stop Using Now

Lupin Pharmaceuticals recalls Tydemy birth control tablets due to subpotent drug levels. Affected lots expire May 2022. Stop using immediately to avoid potential ineffective contraception.

🇺🇸 FDA recall #D-0264-2022DrugLupin Pharmaceuticals ›
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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 that may not contain enough active ingredients. This could lead to ineffective contraception if used without replacement. Read more at govinfonow.com/recall/35529-lupin-tydemy-subpotent-drug-recall-stop-using-now.

Source Summary by GovInfoNow · govinfonow.com/recall/35529-lupin-tydemy-subpotent-drug-recall-stop-using-now · Updated August 18, 2026 · FDA enforcement record: FDA #D-0264-2022

Cite this page

“Lupin Tydemy: Subpotent Drug Recall - Stop Using Now.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35529-lupin-tydemy-subpotent-drug-recall-stop-using-now. Based on FDA recall #D-0264-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0264-2022%22&limit=1).

Lupin Pharmaceuticals Inc. recalled Tydemy tablets nationwide due to subpotent drug risks, the Food and Drug Administration said on Nov. 19, 2021. The voluntary Class III recall involved 4,113 cartons distributed across the United States.

How to tell if you have it

  • Brand: Lupin Pharmaceuticals
  • Product: Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets)
  • Lot codes: L000784 and L000785
  • Expiration date: May 2022
  • NDCs: Individual wallet NDC 68180-904-11; Carton NDC 68180-904-13

The hazard

The recall addresses the hazard of subpotent drug, meaning the medication may not contain the expected potency of active ingredients. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Lupin Pharmaceuticals Inc. has 90 other recalls on record since Jan. 31, 2013. Other recent recalls include the Lupin Clobetasol Cream Recall (Aug. 3, 2026), the Lupin Glucagon Emergency Kit Recall (June 23, 2026), and the Lupin prednisolone acetate ophthalmic suspension recall (June 4, 2026). Other recent recalls of similar products include the Unichem busPIRone 5mg Tablets Recall (April 13, 2026), the Major Pharmaceuticals Levothyroxine Tablets Recall (July 13, 2026), and the Accord Healthcare Levothyroxine Tablets Recall (Aug. 6, 2026).

How to tell if you have this one

Check the individual wallet NDC 68180-904-11 and carton NDC 68180-904-13. The lot numbers L000784 or L000785 with expiration date May 2022 indicate the recalled product.

  • Brand
    Lupin Pharmaceuticals
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop Using Now

    Immediately stop using the recalled Tydemy tablets to prevent potential ineffective contraception.

Where it went and when

Where it was distributed

Distributed nationwide.

Alaska: yesAKMaine: yesMEVermont: yesVTNew Hampshire: yesNHWashington: yesWAIdaho: yesIDMontana: yesMTNorth Dakota: yesNDMinnesota: yesMNIllinois: yesILWisconsin: yesWIMichigan: yesMINew York: yesNYRhode Island: yesRIMassachusetts: yesMAOregon: yesORNevada: yesNVWyoming: yesWYSouth Dakota: yesSDIowa: yesIAIndiana: yesINOhio: yesOHPennsylvania: yesPANew Jersey: yesNJConnecticut: yesCTCalifornia: yesCAUtah: yesUTColorado: yesCONebraska: yesNEMissouri: yesMOKentucky: yesKYWest Virginia: yesWVVirginia: yesVAMaryland: yesMDDelaware: yesDEArizona: yesAZNew Mexico: yesNMKansas: yesKSArkansas: yesARTennessee: yesTNNorth Carolina: yesNCSouth Carolina: yesSCDistrict of Columbia: yesDCOklahoma: yesOKLouisiana: yesLAMississippi: yesMSAlabama: yesALGeorgia: yesGAHawaii: yesHITexas: yesTXFlorida: yesFL

FDA distribution: “nationwide within 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 12 months after the firm started it.

1. Firm started the recall: Nov 19, 202112. FDA classified it Class III: Dec 1, 202123. Published in FDA’s Enforcement Report: Dec 8, 202134. FDA terminated the recall: Nov 15, 2022420212022
  1. Firm started the recall
  2. FDA classified it Class III
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

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

✎ GovInfoNow

Questions people ask

What should I do if I have the recalled product?

Stop using the tablets immediately and contact your healthcare provider for alternative contraception options.

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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-0264-2022 (November 19, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0264-2022 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.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA