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Lower risk Drug recall · FDA · Published February 15, 2019

Heritage Pharmaceuticals Etomidate Injection Recall: Subpotent Drug Risk

Heritage Pharmaceuticals recalls Etomidate Injection vials due to subpotent drug content. Affected vials have specific NDC and lot numbers. Consumers should contact the manufacturer for details.

🇺🇸 FDA recall #D-1065-2019DrugHeritage Pharmaceuticals ›
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Recalling firmHeritage Pharmaceuticals, Inc.1 Tower Center Blvd Ste 1700 · East Brunswick, NJ 08816-1145
✎ GovInfoNow plain-language explainer

What happened, in plain English

Heritage Pharmaceuticals is recalling Etomidate Injection vials that may contain less active drug than labeled. This could lead to ineffective treatment if used as prescribed. The recall affects specific vial lots manufactured in India. Read more at govinfonow.com/recall/39189-heritage-pharmaceuticals-etomidate-injection-recall-subpotent-drug-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/39189-heritage-pharmaceuticals-etomidate-injection-recall-subpotent-drug-risk · Updated October 5, 2026 · FDA enforcement record: FDA #D-1065-2019

Cite this page

“Heritage Pharmaceuticals Etomidate Injection Recall: Subpotent Drug Risk.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/39189-heritage-pharmaceuticals-etomidate-injection-recall-subpotent-drug-risk. Based on FDA recall #D-1065-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1065-2019%22&limit=1).

Why it’s dangerous

The vials contain a subpotent drug, meaning they have less active ingredient than labeled. This could result in the medication being less effective than intended during medical procedures. However, the risk of serious harm is not clearly described in the recall.

Who’s affected

Prescribers and patients who have received the recalled Etomidate Injection vials for medical use. Those using the vials for anesthesia or sedation are most at risk.

How to tell if you have this one

Check for NDC 23155-160-31 and lot numbers AMA701 (expiring March 2019) or AMA702/AMA703 (expiring August 2019). The vials are single-dose, 10 mL, for prescription use only.

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

What to do — step by step

  1. Check Vial Details

    Look for NDC 23155-160-31 and lot numbers AMA701, AMA702, or AMA703 on the vial.

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 within the United States” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 2 years after the firm started it.

1. Firm started the recall: Feb 15, 201912. FDA classified it Class II: Mar 27, 201923. Published in FDA’s Enforcement Report: Mar 27, 201934. FDA terminated the recall: Mar 4, 2021420192021
  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-1065-2019 (February 15, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1065-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 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