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Stop using now Drug recall · FDA · Published December 22, 2017

Hetero Recalls Simvastatin 40mg Due to Razor Blade Hazard

Hetero Labs recalls Simvastatin Tablets USP 40 mg (1000-count) due to a metallic razor blade found in one bottle. Check your lot number.

🇺🇸 FDA recall #D-0223-2018DrugHetero Labs ›
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Recalling firmHetero Labs, Ltd. - Unit IIIPlot 22-110, Part Ii, Ida, Rangareddy, Jeedimetla · Hyderabad, India
✎ GovInfoNow plain-language explainer

What happened, in plain English

Hetero Labs, Ltd. - Unit III is recalling Simvastatin Tablets, USP, 40 mg, specifically the 1000-count bottles manufactured for Camber Pharmaceuticals, Inc. The recall was initiated because a metallic razor blade was discovered inside one of the bottles. This poses a serious physical injury risk if ingested. Read more at govinfonow.com/recall/41002-hetero-recalls-simvastatin-40mg-due-to-razor-blade-hazard.

Source Summary by GovInfoNow · govinfonow.com/recall/41002-hetero-recalls-simvastatin-40mg-due-to-razor-blade-hazard · Updated October 11, 2026 · FDA enforcement record: FDA #D-0223-2018

Cite this page

“Hetero Recalls Simvastatin 40mg Due to Razor Blade Hazard.” GovInfoNow, updated October 11, 2026. https://govinfonow.com/recall/41002-hetero-recalls-simvastatin-40mg-due-to-razor-blade-hazard. Based on FDA recall #D-0223-2018 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0223-2018%22&limit=1).

Why it’s dangerous

The presence of a metallic razor blade within the medication bottle creates a severe risk of internal injury or choking if the contaminated tablets are consumed.

Who’s affected

Individuals who have purchased Simvastatin Tablets USP 40 mg in 1000-count bottles from Camber Pharmaceuticals, Inc., distributed nationwide in the U.S. before December 22, 2017.

How to tell if you have this one

Check your bottle for the following details: Product is Simvastatin Tablets, USP, 40 mg, in a 1000-count bottle. Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ. NDC 31722-513-10. Lot Number E171280 with an expiration date of 06/19.

  • Brand
    Hetero Labs
  • 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 affected bottle due to the risk of injury from the foreign object.

  2. Contact your pharmacy or doctor

    Reach out to your healthcare provider or pharmacist immediately for guidance on replacing the medication and next steps.

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: “U.S.A. 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 3 months after the firm started it.

1. Firm started the recall: Dec 22, 201712. FDA classified it Class III: Jan 16, 201823. Published in FDA’s Enforcement Report: Jan 24, 201834. FDA terminated the recall: Mar 23, 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.

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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-0223-2018 (December 22, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0223-2018 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