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Lower risk Drug recall · FDA · Published November 2, 2016

Ascend Metformin Tablets Recall: Foreign Amlodipine Tablets Found

Ascend Laboratories recalls 500mg Metformin tablets due to reports of Amlodipine tablets contaminating the product. This is a prescription-only medication.

🇺🇸 FDA recall #D-0163-2017DrugAscend Laboratories ›
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Recalling firmAscend Laboratories LLC180 Summit Ave Ste 200 · Montvale, NJ 07645-1722
✎ GovInfoNow plain-language explainer

What happened, in plain English

Ascend Laboratories is recalling 500mg Metformin Hydrochloride Tablets because some bottles contain foreign Amlodipine tablets. This could lead to unintended medication intake if taken without knowing the mix-up. Read more at govinfonow.com/recall/42265-ascend-metformin-tablets-recall-foreign-amlodipine-tablets-found.

Source Summary by GovInfoNow · govinfonow.com/recall/42265-ascend-metformin-tablets-recall-foreign-amlodipine-tablets-found · Updated October 9, 2026 · FDA enforcement record: FDA #D-0163-2017

Cite this page

“Ascend Metformin Tablets Recall: Foreign Amlodipine Tablets Found.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42265-ascend-metformin-tablets-recall-foreign-amlodipine-tablets-found. Based on FDA recall #D-0163-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0163-2017%22&limit=1).

Why it’s dangerous

The recall reports that some bottles of Metformin Hydrochloride Tablets contain Amlodipine tablets as foreign material. This could happen during manufacturing or distribution, leading to patients taking an unintended medication.

Who’s affected

Prescription holders of Metformin Hydrochloride Tablets 500mg, 1000 tablets, manufactured by Alkem Laboratories Ltd. in Mumbai, India. Those who have taken the product without noticing the foreign tablets are at risk of unintended medication intake.

How to tell if you have this one

Check for the product name 'Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets' with NDC code 67877-217-10. The lot number is 6121056, expiring May 2019.

  • Brand
    Ascend Laboratories
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Your Product

    Look for the NDC code 67877-217-10 and lot number 6121056 on the packaging.

Where it went and when

Where it was distributed

Distributed in 5 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: not listedPANew Jersey: not listedNJConnecticut: not listedCTCalifornia: not listedCAUtah: 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: yesTNNorth Carolina: not listedNCSouth Carolina: yesSCDistrict of Columbia: not listedDCOklahoma: not listedOKLouisiana: not listedLAMississippi: not listedMSAlabama: yesALGeorgia: yesGAHawaii: not listedHITexas: not listedTXFlorida: yesFL

FDA distribution: “AL, FL, GA, SC & TN” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Florida, Georgia, South Carolina, Tennessee.

Recall timeline

FDA terminated this recall 7 months after the firm started it.

1. Firm started the recall: Nov 2, 201612. FDA classified it Class II: Nov 29, 201623. Published in FDA’s Enforcement Report: Dec 7, 201634. FDA terminated the recall: Jun 7, 2017420162017
  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.

✎ GovInfoNow

Questions people ask

What should I do if I have this product?

Check the NDC code and lot number on the packaging to see if it's affected. If it matches, contact your healthcare provider.

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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-0163-2017 (November 2, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0163-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on October 9, 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