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Unrated Drug recall · FDA · Published May 2, 2017

Lupin Famotidine Oral Suspension Recall: CGMP Deviations Risk

Lupin Pharmaceuticals recalls Famotidine oral suspension (40mg/5mL, 50mL bottle) due to CGMP deviations. This medication is prescription-only and may pose safety risks if not handled properly.

🇺🇸 FDA recall #D-1127-2017DrugLupin Pharmaceuticals ›
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Recalling firmLupin Pharmaceuticals Inc.111 S Calvert St Fl 21ST · Baltimore, MD 21202-6174
✎ GovInfoNow plain-language explainer

What happened, in plain English

Lupin Pharmaceuticals is recalling Famotidine oral suspension (40 mg/5 mL, 50 mL bottle) because of manufacturing quality control issues. This prescription medication could pose safety risks if not handled properly. Read more at govinfonow.com/recall/41634-lupin-famotidine-oral-suspension-recall-cgmp-deviations-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/41634-lupin-famotidine-oral-suspension-recall-cgmp-deviations-risk · Updated October 8, 2026 · FDA enforcement record: FDA #D-1127-2017

Cite this page

“Lupin Famotidine Oral Suspension Recall: CGMP Deviations Risk.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/41634-lupin-famotidine-oral-suspension-recall-cgmp-deviations-risk. Based on FDA recall #D-1127-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1127-2017%22&limit=1).

Why it’s dangerous

CGMP deviations refer to manufacturing quality control issues that could affect the safety and effectiveness of the medication. These deviations may lead to potential risks if the medication is not handled properly.

Who’s affected

Prescription patients who received this specific Famotidine oral suspension bottle from Lupin Pharmaceuticals. Those with medical conditions requiring this medication are most at risk.

How to tell if you have this one

Check for the product name 'Famotidine for Oral Suspension USP', strength 40 mg/5 mL, and 50 mL bottle. The prescription-only medication was manufactured by Lupin Pharmaceuticals, Inc. in Baltimore, Maryland with lot number G606950 (expires 07/18).

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

What to do — step by step

  1. Check Product Details

    Identify if you have the Famotidine oral suspension (40 mg/5 mL, 50 mL bottle) with lot number G606950.

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 in the 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 11 months after the firm started it.

1. Firm started the recall: May 2, 201712. FDA classified it Class III: Sep 1, 201723. Published in FDA’s Enforcement Report: Sep 13, 201734. FDA terminated the recall: Mar 28, 2018420172018
  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

Is this medication safe to use?

The recall is due to CGMP deviations, which may affect safety and effectiveness. The manufacturer recommends checking if you have the specific lot number and following the action steps.

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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-1127-2017 (May 2, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1127-2017 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.
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