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Use caution Drug recall · FDA · Published June 22, 2016

Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles

Teva North America is recalling specific lots of Albuterol Sulfate Syrup due to the presence of black particles. Check your bottle's lot number and expiration date.

🇺🇸 FDA recall #D-1455-2016DrugTeva ›
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Recalling firmTeva North America425 Privet Rd · Horsham, PA 19044-1220
✎ GovInfoNow plain-language explainer

What happened, in plain English

Teva North America has recalled one lot of Albuterol Sulfate Syrup because it may contain foreign substances described as brown fibrous material. The affected product is a prescription-only syrup manufactured by Contract Pharmaceuticals in Canada. This recall involves 8,052 bottles distributed nationwide. Read more at govinfonow.com/recall/42577-teva-recalls-albuterol-sulfate-syrup-due-to-foreign-particles.

Source Summary by GovInfoNow · govinfonow.com/recall/42577-teva-recalls-albuterol-sulfate-syrup-due-to-foreign-particles · Updated October 9, 2026 · FDA enforcement record: FDA #D-1455-2016

Cite this page

“Teva Recalls Albuterol Sulfate Syrup Due to Foreign Particles.” GovInfoNow, updated October 9, 2026. https://govinfonow.com/recall/42577-teva-recalls-albuterol-sulfate-syrup-due-to-foreign-particles. Based on FDA recall #D-1455-2016 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1455-2016%22&limit=1).

Why it’s dangerous

The syrup contains black particles, which are described generically as cellulose-based bundles of brown fibrous material. Ingesting these foreign substances could pose a health risk to the user.

Who’s affected

Consumers who purchased Albuterol Sulfate Syrup from the specific lot listed below are affected. Individuals using this medication for respiratory conditions may be at risk of ingesting foreign particles.

How to tell if you have this one

Check if you have Albuterol Sulfate Syrup, 2 mg/ 5 mL in a 473 mL bottle with NDC 0093-0661-16. Verify that the lot number is 95113 and the expiration date is 01/2017.

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

What to do — step by step

  1. Check Your Bottle

    Verify if your Albuterol Sulfate Syrup matches NDC 0093-0661-16, Lot # 95113, and expires in 01/2017.

  2. Contact Your Pharmacist

    Reach out to your pharmacy or healthcare provider for instructions on how to return the product or obtain a replacement.

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

Distributed nationwide.

Recall timeline

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

1. Firm started the recall: Jun 22, 201612. FDA classified it Class II: Aug 9, 201623. Published in FDA’s Enforcement Report: Aug 17, 201634. FDA terminated the recall: Jan 26, 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.

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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-1455-2016 (June 22, 2016) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1455-2016 to see it in context.
  • Plain-language summary written by qwen3.6:35b-a3b 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