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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Critical RiskFDA Drug
Medications & Supplements/Prescription Drugs

Enoxaparin Sodium Injection Recalled for Temperature Shipping Excursions

Agency Publication Date: November 30, 2021
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Summary

Sandoz Inc. has recalled 45,036 cartons of Enoxaparin Sodium Injection, USP (40 mg/0.4 mL), a medication used to prevent blood clots. The product was exposed to improper temperatures during shipping (temperature excursion), which could affect its quality. This recall affects single-dose syringes with an automatic safety device distributed nationwide to hospitals and pharmacies. No injuries or incidents have been reported to date.

Risk

Exposure to temperatures outside of the approved storage range can cause the medication to lose its effectiveness or degrade. If the medication is less effective, patients may not receive the intended protection against dangerous blood clots.

What You Should Do

  1. This recall affects Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, sold in cartons of 10 single-dose syringes (NDC 00781-3246-64) or individual syringes (NDC 00781-3246-02).
  2. Check your medication for lot number SAB06761A with an expiration date of 04/2023.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact the manufacturer for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional information regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Enoxaparin Sodium Injection, USP (40 mg/0.4 mL)
Variants: 40 mg/0.4 mL, Single-Dose Syringes, Automatic Safety Device, Subcutaneous Injection
Lot Numbers:
SAB06761A (Exp 04/2023)
NDC:
00781-3246-02
00781-3246-64

Manufactured by Shenzhen Techdow Pharmaceutical Co., Ltd. for Sandoz Inc.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89033
Status: Resolved
Manufacturer: Sandoz Inc
Sold By: pharmacies; hospitals
Manufactured In: China, United States
Units Affected: 45,036 cartons
Distributed To: Nationwide
Agency Last Updated: December 16, 2021

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.