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Unrated Drug recall · FDA · Published January 12, 2017

Actavis Albuterol Inhaler Recall: Impurities May Cause Harm

Actavis recalls Albuterol Sulfate Inhalation Solution vials due to impurities. This medication may cause harm if used as intended. Affected vials have specific lot numbers and expiration dates.

🇺🇸 FDA recall #D-0439-2017DrugActavis ›
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Recalling firmActavis Inc400 Interpace Pkwy · Parsippany, NJ 07054-1120
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What happened, in plain English

Actavis is recalling Albuterol Sulfate Inhalation Solution vials that may contain impurities. Using these vials could lead to health risks, so affected users should stop using them and contact their doctor. Read more at govinfonow.com/recall/42090-actavis-albuterol-inhaler-recall-impurities-may-cause-harm.

Source Summary by GovInfoNow · govinfonow.com/recall/42090-actavis-albuterol-inhaler-recall-impurities-may-cause-harm · Updated October 8, 2026 · FDA enforcement record: FDA #D-0439-2017

Cite this page

“Actavis Albuterol Inhaler Recall: Impurities May Cause Harm.” GovInfoNow, updated October 8, 2026. https://govinfonow.com/recall/42090-actavis-albuterol-inhaler-recall-impurities-may-cause-harm. Based on FDA recall #D-0439-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0439-2017%22&limit=1).

Why it’s dangerous

The product failed impurities and degradation specifications. This means the medication may contain harmful substances that could cause health issues if used as intended.

Who’s affected

People with a prescription for this medication from Watson Laboratories. Those using the product without a prescription are not affected.

How to tell if you have this one

Check for vials labeled 'Albuterol Sulfate Inhalation Solution, USP, 0.021% (0.63 mg / 3 mL), 3mL'. The lot numbers listed are GA51265 through GA51749 with specific expiration dates.

  • Brand
    Actavis
  • Category
    Drug
Based on the official FDA remedy

What to do — step by step

  1. Check Product Details

    Look for the lot numbers GA51265, GA51454, GA51553, GA51583, GA51598, GA51724, GA51725, or GA51749 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 in the US” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 14 months after the firm started it.

1. Firm started the recall: Jan 12, 201712. FDA classified it Class III: Jan 24, 201723. Published in FDA’s Enforcement Report: Feb 1, 201734. FDA terminated the recall: Mar 5, 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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Questions people ask

What should I do if I have the recalled product?

Contact your doctor for advice on what to do next.

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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-0439-2017 (January 12, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0439-2017 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