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Stop using now Drug recall · FDA · Published January 20, 2021

Aurobindo Famotidine 40mg Recall: Foreign Tablets Found

Aurobindo Pharma recalls 1,296 bottles of Famotidine 40mg due to contamination with Famotidine 20mg and ibuprofen 400mg tablets.

🇺🇸 FDA recall #D-0290-2021DrugAurobindo Pharma ›
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Recalling firmAurobindo Pharma USA Inc.279 Princeton Hightstown Rd · East Windsor, NJ 08520-1401
✎ GovInfoNow plain-language explainer

Aurobindo Pharma USA Inc. is recalling Famotidine Tablets USP 40mg in 1,000-count bottles because the product was contaminated with foreign tablets. Specifically, Famotidine 20mg and ibuprofen 400mg tablets were found mixed into the lot of Famotidine 40mg. This recall affects 1,296 bottles distributed to Texas, California, Georgia, and Pennsylvania. Read more at govinfonow.com/recall/36549-aurobindo-famotidine-40mg-recall-foreign-tablets-found.

Source Summary by GovInfoNow · govinfonow.com/recall/36549-aurobindo-famotidine-40mg-recall-foreign-tablets-found · Updated October 11, 2026 · FDA enforcement record: FDA #D-0290-2021

Cite this page

“Aurobindo Famotidine 40mg Recall: Foreign Tablets Found.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/36549-aurobindo-famotidine-40mg-recall-foreign-tablets-found. Based on FDA recall #D-0290-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0290-2021%22&limit=1).

Aurobindo Pharma USA Inc. recalled Famotidine Tablets USP 40mg in 1,000-count bottles due to the presence of foreign tablets, according to the FDA on Jan. 20, 2021. The agency announced the voluntary Class II recall after ibuprofen and lower-dose famotidine tablets were found in the product.

How to tell if you have it

  • Brand: Aurobindo Pharma
  • Product: Famotidine Tablets USP 40mg
  • Packaging: 1,000-count bottles, Rx only
  • NDC: 65862-860-99
  • Lot #: P2000467
  • Expiration: 7/2022
  • Distribution: TX, CA, GA, PA
  • Units affected: 1,296 bottles

The hazard

The recall was issued because Famotidine 20mg and ibuprofen 400mg tablets were found in a lot of famotidine 40mg. The FDA classified the hazard as Class II.

Context

GovInfoNow's records show Aurobindo Pharma USA Inc. has 32 other recalls on record since April 9, 2013. Recent brand recalls include Dicyclomine Capsules due to empty capsules on July 23, 2026, and Acetaminophen Tablets recalled for brown tablet discoloration risk on May 22, 2025. Other recent recalls of similar products include Taro's Children's Ibuprofen recall due to foreign substance on March 2, 2026, Golden State Medical's Primidone Tablets recall due to contamination on April 27, 2026, and Amneal's Primidone Tablets recall due to cross-contamination risk on June 3, 2026.

How to tell if you have this one

Check your bottle for the label 'Famotidine Tablets USP 40mg' distributed by Aurobindo Pharma USA Inc. Look for NDC 65862-860-99 and Lot # P2000467 with an expiration date of 7/2022. The bottles contain 1,000 tablets.

  • Brand
    Aurobindo Pharma
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Stop using the medication

    Do not consume any tablets from the recalled bottles due to the risk of ingesting foreign substances like ibuprofen.

  2. Contact your pharmacist or doctor

    Speak with your healthcare provider about alternative treatments and whether you need to adjust your current medication regimen.

Where it went and when

Where it was distributed

Distributed in 4 states.

Alaska: not listedAKMaine: not listedMEVermont: not listedVTNew Hampshire: not listedNHWashington: not listedWAIdaho: not listedIDMontana: not listedMTNorth Dakota: not listedNDMinnesota: not listedMNIllinois: not listedILWisconsin: not listedWIMichigan: not listedMINew York: not listedNYRhode Island: not listedRIMassachusetts: not listedMAOregon: not listedORNevada: not listedNVWyoming: not listedWYSouth Dakota: not listedSDIowa: not listedIAIndiana: not listedINOhio: not listedOHPennsylvania: yesPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: yesCAUtah: not listedUTColorado: not listedCONebraska: not listedNEMissouri: not listedMOKentucky: not listedKYWest Virginia: not listedWVVirginia: not listedVAMaryland: not listedMDDelaware: not listedDEArizona: not listedAZNew Mexico: not listedNMKansas: not listedKSArkansas: not listedARTennessee: not listedTNNorth Carolina: not listedNCSouth Carolina: not listedSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: not listedALGeorgia: yesGAHawaii: not listedHITexas: yesTXFlorida: not listedFL

FDA distribution: “TX, CA, GA, PA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: California, Georgia, Pennsylvania, Texas.

Recall timeline

FDA terminated this recall 2.7 years after the firm started it.

1. Firm started the recall: Jan 20, 202112. FDA classified it Class II: Feb 26, 202123. Published in FDA’s Enforcement Report: Mar 10, 202134. FDA terminated the recall: Oct 12, 2023420212023
  1. Firm started the recall
  2. FDA classified it Class II
  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.

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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-0290-2021 (January 20, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0290-2021 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