Apotex Enoxaparin Syringes: Label Mixup Risk
Apotex recalls 10x1mL Enoxaparin syringes with incorrect labeling that may cause dosing errors. Affected units have 150mg/mL markings instead of 100mg/mL. Contact for return instructions.
Lower-risk recall
Labeling; Label Mixup; syringe barrels may containing markings for 150 mg/mL (corresponding to 120 mg/0.8mL strength) instead of 100 mg/mL markings (corresponding to 100 mg/mL strength)
Contact the company
What happened, in plain English
Apotex is recalling 10 single-dose syringes of Enoxaparin injection due to labeling errors. The syringes may show markings for 150 mg/mL instead of 100 mg/mL, which could lead to incorrect dosing if used without checking the label. Read more at govinfonow.com/recall/36533-apotex-enoxaparin-syringes-label-mixup-risk.
Source Summary by GovInfoNow · govinfonow.com/recall/36533-apotex-enoxaparin-syringes-label-mixup-risk · Updated October 4, 2026 · FDA enforcement record: FDA #D-0261-2021
Cite this page
“Apotex Enoxaparin Syringes: Label Mixup Risk.” GovInfoNow, updated October 4, 2026. https://govinfonow.com/recall/36533-apotex-enoxaparin-syringes-label-mixup-risk. Based on FDA recall #D-0261-2021 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0261-2021%22&limit=1).
Why it’s dangerous
The syringes may have markings indicating 150 mg/mL strength instead of the correct 100 mg/mL. This could lead to incorrect dosing if the user misreads the label, potentially causing treatment errors.
Who’s affected
Patients using Enoxaparin injections for blood thinning may be affected. Those with specific medical conditions requiring precise dosing are at higher risk.
How to tell if you have this one
Check for syringes with 150 mg/mL markings on the barrel instead of 100 mg/mL. The product was sold with NDC 60505-0795-4 and batch CS008 (expiring April 2022).
- Brand
Apotex- Product
Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection- Category
Drug
All 2 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class I- Status
Ongoing- Distribution
Nationwide
| Recall number | Product, codes & lots | Quantity |
|---|---|---|
| D-0261-2021 | Enoxaparin Sodium Injection, USP 100 mg/mL Single Dose Syringes with Automatic Safety Device For Subcutaneous Injection 10 x 1 mL Single Dose Syringes Rx Only, Manufactured by: Gland Pharma Ltd. Hyderabad, India Manufactured for: Apotex Corp. Weston, FL 33326 NDC 60505-0795-4 UPC 360505079544 (carton) NDC 60505-0795-1 UPC (01)10360505079510 (label); Batch: CS008 Exp. 04/2022 | 6670 cartons |
| D-0262-2021 | 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); Batch: CT003 Exp. 05/2022 | 6832 cartons |
What to do — step by step
Check Label Markings
Look for 150 mg/mL markings on the syringe barrel instead of 100 mg/mL.
Where it went and when
Where it was distributed
Distributed nationwide.
FDA distribution: “Nationwide” States read from FDA’s own wording; “not listed” means the notice does not name it.
Distributed nationwide.
Recall timeline
FDA published this recall 15 days after the firm started it.
- Firm started the recall
- FDA classified it Class I
- Published in FDA’s Enforcement Report
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-0261-2021 (February 2, 2021) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0261-2021 to see it in context.
- Plain-language summary written by qwen3:4b on October 4, 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.