Enoxaparin Sodium Injection, USP 120 mg/ 0.8 mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 0.8 mL Single Dose Syringes Rx Only,Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0796-4 UPC 360505079543 (carton) NDC 60505-0796-0 UPC (01)10360505079602 (label)
Drug Recall
Official source record
- Recall number
- D-0262-2021
- Event ID
- 87269
- Classification
- Class I
- Status
- Ongoing
- Recalling company
- Apotex Corp.
- Reason for recall
- Labeling; Label Mixup; syringe barrels may contain markings for 100 mg/mL (corresponding to 100 mg/mL strength) instead of 150 mg/mL (corresponding to 120 mg/0.8mL strength)
- Report date
- February 17, 2021
- Recall initiation date
- February 2, 2021
- Termination date
- Not terminated as of this source record
- Distribution pattern
- Nationwide
Where this information comes from
View FDA enforcement record -- the specific openFDA drug enforcement record this summary was built from.
This record comes from FDA's Enforcement Report database. Not every Enforcement Report record has a separate FDA.gov recall-announcement page.
FDA Enforcement Reports -- FDA's general, official recall and enforcement information.
Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for details, or FDA Enforcement Reports versus recall announcements for why that gap exists. New to reading a recall record? See how to read an FDA recall record and what recall statuses mean.
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Frequently asked questions
What does a Class I mean?
FDA classifies this recall as Class I. See how to read an FDA recall record for what each classification level means.
Is this recall still active?
According to the FDA, this recall's status is "Ongoing." Always confirm the current status using the source links below, since status can change after Public Health Trace last retrieved this record.
What should I do if I have this medication?
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Official guidance and record verification
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Public Health Trace last retrieved this record on July 28, 2026.
Public Health Trace republishes FDA's drug recall record and does not provide medical or medication instructions -- review the official FDA record and FDA's general drug recall guidance (linked below) for what to do.
View the official FDA record · General drug recall guidance from FDA
Public Health Trace republishes official FDA drug recall information -- it is not affiliated with the FDA, does not verify or supplement what the source has published, and does not provide medical advice. Never start, stop, or change a medication based on this page. Always follow the guidance of your pharmacist or physician, and consult the official source links above for the most current information. Read the full medical disclaimer.