CLASS I ONGOING Drug recall · Reported 17 Feb 2021 · FDA Enforcement Report
Enoxaparin Sodium Injection recalled by Apotex
Apotex is recalling Enoxaparin Sodium Injection, USP 120 mg/ Single Dose Syringes with Automatic Safety, distributed nationwide in the US. The recall was initiated on 2 Feb 2021 and the FDA has classified it as Class I.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0262-2021
- FDA event ID
- 87269
- Recalling firm
- Apotex, Weston, FL
- Classification
- Class I
- Status
- Ongoing
- Recall initiated
- 2 Feb 2021
- FDA classified
- 17 Feb 2021
- Reported
- 17 Feb 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Two or more of the following: Email, Fax, Letter, Press Release, Telephone, Visit
- Reason category
- Packaging Defects
- Drug class
- Blood Thinners
Timeline
| 2 Feb 2021 | Recall initiated by company | |
| 17 Feb 2021 | Classified by FDA | +15 days |
| 17 Feb 2021 | Published in enforcement report | +0 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
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)
Packaging recalls include wrong labels, wrong products in the wrong bottle, missing leaflets, short-filled or empty capsules and seals that fail.
Product as listed by the FDA
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)
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
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)
Which lots are affected?
Batch: CT003 Exp. 05/2022
Where was it sold?
Nationwide
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
1 other product · FDA event 87269This product is part of a recall event; the main page for the event is Enoxaparin Sodium Injection recalled by Apotex.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |
More recalls from Apotex
All 76| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Paroxetine Extended-Release Tablets, 37.5mg recalled by ApotexParoxetine Hydrochloride | Apotex | Potency & Assay | Nationwide |
| Drug | CLASS II | Paxil CR, Paroxetine, Extended-Release Tablets, 37.5mg recalled | Apotex | Potency & Assay | Nationwide |
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| Drug | CLASS II | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution 0.2%/0.5%* recalledBrimonidine Tartrate/timolol Maleate Ophthalmic Solution | Apotex | Sterility | Nationwide |
| Drug | CLASS II | Ketorolac Tromethamine Ophthalmic Solution recalled by ApotexKetorolac Tromethamine | Apotex | Sterility | Nationwide |
Other Enoxaparin recalls
All 6| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Enoxaparin Sodium Injection, USP, 30 mg recalled by Cardinal HealthEnoxaparin Sodium | Cardinal Health | Packaging Defects | KS |
| Drug | CLASS II | Enoxaparin Sodium Injection recalled by Cardinal HealthcareEnoxaparin Sodium | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection, USP, 40 mg recalled by Sandoz | Sandoz | Temperature Abuse | Nationwide |
| Drug | CLASS I | Enoxaparin Sodium Injection recalled by Apotex | Apotex | Packaging Defects | Nationwide |
| Drug | CLASS III | Enoxaparin Sodium, Injection 120 mg/, pre-filled recalled | Sanofi-Aventis U.S | Packaging Defects | Nationwide |