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Lower risk Drug recall · FDA · Published September 25, 2017

Sandoz Ampicillin Injections: Missing Labels in Some Packs

Sandoz recalls 10-count packs of Ampicillin injections (500mg/vial) due to missing labels on some vials. This could lead to incorrect dosing if used without proper labeling.

🇺🇸 FDA recall #D-1179-2017DrugSandoz ›
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Recalling firmSandoz Inc100 College Rd W · Princeton, NJ 08540-6604
✎ GovInfoNow plain-language explainer

Sandoz is recalling 10-count packs of Ampicillin injections (500mg per vial) because some vials in the shrink wrap packs have missing labels. This could cause incorrect dosing if the vials are used without proper labeling. Read more at govinfonow.com/recall/41172-sandoz-ampicillin-injections-missing-labels-in-some-packs.

Source Summary by GovInfoNow · govinfonow.com/recall/41172-sandoz-ampicillin-injections-missing-labels-in-some-packs · Updated August 19, 2026 · FDA enforcement record: FDA #D-1179-2017

Cite this page

“Sandoz Ampicillin Injections: Missing Labels in Some Packs.” GovInfoNow, updated August 19, 2026. https://govinfonow.com/recall/41172-sandoz-ampicillin-injections-missing-labels-in-some-packs. Based on FDA recall #D-1179-2017 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1179-2017%22&limit=1).

The FDA announced on September 25, 2017, that Sandoz Inc is recalling Ampicillin for Injection, USP, 500 mg per vial due to missing labels on some vials within shrink wrap packs. The recall affects 13,435 units distributed nationwide in the USA and Puerto Rico.

How to tell if you have it

  • Brand: Sandoz
  • Product: Ampicillin for Injection, USP, 500 mg per vial
  • NDC: 0781-3407-78 (single vial), 0781-3407-95 (10-count shrink wrap packs)
  • Lot code: GH8254
  • Expiration date: 06/19
  • Quantity: 13,435 shrink wrap packs

The hazard

The hazard involves missing labels on some vials of ampicillin within the shrink wrap pack, according to a customer complaint. The FDA classified this as a Class III recall.

Context

GovInfoNow's records show Sandoz Inc has 29 other recalls on record since October 9, 2013. Recent Sandoz recalls include Focalin XR 5mg Capsules with missing lot/exp dates on June 1, 2026, Cyclophosphamide Injection due to temperature excursion risk on September 5, 2025, and Ciprofloxacin Otic Suspension for temperature abuse risk on August 13, 2025. Other recent recalls of similar products include American Regent Levocarnitine Injection (April 16, 2026), Winder Morphine Sulfate Oral Solution (November 26, 2025), and Greenstone Methylprednisolone Tablets (January 15, 2026).

How to tell if you have this one

Check for 10-count shrink wrap packs of Ampicillin injections (500mg/vial) with NDC 0781-3407-95. The product was manufactured in Austria by Sandoz GmbH or Sandoz Inc. in Princeton, NJ.

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

What to do — step by step

  1. Check Labels

    Inspect vials for missing labels; if labels are missing, do not use 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: yesFLPuerto Rico: yesPR

FDA distribution: “Nationwide in the USA and Puerto Rico” States read from FDA’s own wording; “not listed” means the notice does not name it.

Distributed nationwide.

Recall timeline

FDA terminated this recall 18 months after the firm started it.

1. Firm started the recall: Sep 25, 201712. FDA classified it Class III: Sep 28, 201723. Published in FDA’s Enforcement Report: Oct 4, 201734. FDA terminated the recall: Apr 8, 2019420172019
  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-1179-2017 (September 25, 2017) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1179-2017 to see it in context.
  • Plain-language summary written by qwen3:4b on August 19, 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