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Lower risk Drug recall · FDA · Published November 17, 2021

Sandoz Enoxaparin 40mg Syringes Risk from Temperature Abuse During Shipping

Sandoz recalls 40mg enoxaparin syringes due to temperature issues during shipping that could affect safety. Learn if your product is affected and what to do.

🇺🇸 FDA recall #D-0286-2022DrugSandoz ›
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Recalling firmSandoz Inc100 College Rd W · Princeton, NJ 08540-6604
✎ GovInfoNow plain-language explainer

Sandoz is recalling enoxaparin sodium injection syringes because they may have been exposed to incorrect temperatures during shipping. This could lead to the medication being unsafe for use. Read more at govinfonow.com/recall/35533-sandoz-enoxaparin-40mg-syringes-risk-from-temperature-abuse-during-shipping.

Source Summary by GovInfoNow · govinfonow.com/recall/35533-sandoz-enoxaparin-40mg-syringes-risk-from-temperature-abuse-during-shipping · Updated August 18, 2026 · FDA enforcement record: FDA #D-0286-2022

Cite this page

“Sandoz Enoxaparin 40mg Syringes Risk from Temperature Abuse During Shipping.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/35533-sandoz-enoxaparin-40mg-syringes-risk-from-temperature-abuse-during-shipping. Based on FDA recall #D-0286-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0286-2022%22&limit=1).

The FDA announced on 2021-11-17 that Sandoz Inc is recalling Enoxaparin Sodium Injection, USP due to temperature abuse during shipping. The agency classified the recall as Class I.

How to tell if you have it

  • Brand: Sandoz
  • Product: Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection
  • NDC: 00781-3246-02 (Syringes), 00781-3246-64 (Carton)
  • Lot #: SAB06761A
  • Expiration: 04/2023
  • Quantity: 45,036 cartons
  • Distribution: Nationwide in the US

The hazard

The recall addresses temperature excursion during shipping that may compromise the product. The FDA classified this as a Class I recall.

Context

GovInfoNow's records show Sandoz Inc has 29 other recalls on record since 2013-10-09. Recent Sandoz recalls include Focalin XR 5mg Capsules (2026-06-01), Cyclophosphamide Injection (2025-09-05), and Ciprofloxacin Otic Suspension (2025-08-13). Other recent recalls of similar products include UDENYCA Injection (2026-01-16), Zoladex Implants (2026-08-31), and Gemcitabine Injection (2026-06-10).

How to tell if you have this one

Check for the product name 'Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Automatic Safety Device'. Look for the lot number SAB06761A or the expiration date of 04/2023.

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

What to do — step by step

  1. Check Product Details

    Look for the lot number SAB06761A or expiration date 04/2023 on the syringe packaging.

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 published this recall 21 days after the firm started it.

1. Firm started the recall: Nov 17, 202112. Published in FDA’s Enforcement Report: Dec 8, 202123. FDA classified it Class I: Dec 16, 202132021
  1. Firm started the recall
  2. Published in FDA’s Enforcement Report
  3. FDA classified it Class I

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-0286-2022 (November 17, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0286-2022 to see it in context.
  • Plain-language summary written by qwen3:4b on August 18, 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