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Lower risk Drug recall · FDA · Published March 24, 2016

Lupin Recalls Escitalopram 20 mg Due to Labeling Errors

Lupin Limited recalls 3,192 bottles of Escitalopram Tablets USP 20 mg because labels have incorrect or missing lot and expiration dates.

🇺🇸 FDA recall #D-1516-201DrugLupin ›
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Recalling firmLupin Limited15-B, Phase 1A, Verna Industrial Area · Verna, Salcette, Goa, India
✎ GovInfoNow plain-language explainer

What happened, in plain English

Lupin Limited is recalling 3,192 bottles of Escitalopram Tablets USP 20 mg manufactured in India. The recall addresses labeling issues where the lot number and/or expiration date are incorrect or missing from the packaging. This affects specific bottles distributed nationwide before March 24, 2016. Read more at govinfonow.com/recall/43098-lupin-recalls-escitalopram-20-mg-due-to-labeling-errors.

Source Summary by GovInfoNow · govinfonow.com/recall/43098-lupin-recalls-escitalopram-20-mg-due-to-labeling-errors · Updated October 11, 2026 · FDA enforcement record: FDA #D-1516-201

Cite this page

“Lupin Recalls Escitalopram 20 mg Due to Labeling Errors.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/43098-lupin-recalls-escitalopram-20-mg-due-to-labeling-errors. Based on FDA recall #D-1516-201 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1516-201%22&limit=1).

Why it’s dangerous

The hazard stems from labeling errors where the lot number and/or expiration date are incorrect or missing. This can make it difficult for patients and pharmacists to verify the medication's freshness and traceability, potentially leading to the use of expired drugs or confusion about product authenticity.

Who’s affected

Consumers who purchased 100-count bottles of prescription Escitalopram Tablets USP 20 mg manufactured by Lupin Limited. The risk is primarily related to medication management confusion due to unclear expiration dates rather than immediate physical harm.

How to tell if you have this one

Check your bottle of Escitalopram Tablets USP 20 mg (Rx Only) for NDC 68180-136-01. Look specifically at the label for Lot # G510086 and an expiration date of 11/17. Verify that the manufacturer is listed as Lupin Limited, Goa 403 722, India.

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

What to do — step by step

  1. Check Your Bottle

    Verify if your bottle matches NDC 68180-136-01 with Lot # G510086 and Exp. 11/17.

  2. Contact Your Pharmacist

    If you have the recalled product, speak with your pharmacist or healthcare provider for guidance on replacement or disposal.

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” 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: Mar 24, 201612. FDA classified it Class III: Sep 21, 201623. Published in FDA’s Enforcement Report: Sep 28, 201634. FDA terminated the recall: Mar 15, 2017420162017
  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

How many bottles are affected by this recall?

The recall involves 3,192 bottles, containing a total of 319,200 tablets.

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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-1516-201 (March 24, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1516-201 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b on October 11, 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