Apotex Recalls Enoxaparin Syringes Due to Labeling Mixup
Apotex Corp. is recalling Enoxaparin Sodium Injection syringes because some barrels may display incorrect concentration markings, posing a risk of dosing errors.
The agency’s classification
FDA (Drugs): Class I
Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 5/5 (Critical).
Highest-severity recall. The hazard can cause serious injury or death. Stop using the product now and follow the agency's instructions.
Our severity reasoning: The agency classification is FDA Class I, which per the rubric mandates a score of 5 (Critical) regardless of other factors, as it indicates a reasonable probability of serious adverse health consequences or death.
Plain-English summary
Apotex Corp. is recalling Enoxaparin Sodium Injection, USP 120 mg/0.8 mL Single Dose Syringes with Automatic Safety Device. The recall involves 6,832 cartons of the product, which was distributed nationwide. The specific batch affected is CT003 with an expiration date of 05/2022.
The recall was initiated due to a labeling mixup. Some syringe barrels may contain markings for 100 mg/mL strength instead of the correct 150 mg/mL strength (which corresponds to the 120 mg/0.8 mL dose). This discrepancy could lead to incorrect dosing if the markings are relied upon for administration.
Healthcare providers and patients should check their inventory for the affected NDC 60505-0796-4 and batch CT003. If found, the product should be quarantined and not used. Patients should consult their healthcare provider for alternative treatment options if they have been using the affected product.
The recalled product
- Product
- 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…
- Manufacturer
- Apotex Corp.
- Category
- Drug — Injectable Medication
- Hazard
- Affected units
- 6,832
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Batch: CT003 Exp. 05/2022
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by Apotex Corp. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 2 products in this recall →Related recalls
Same manufacturer · Apotex Corp.
See all →- ModerateApotex Recalls Paroxetine Hydrochloride Extended-Release Tablets for Dissolution Failure
FDA (Drugs) · 2026-10-07
- ModerateApotex Recalls Paxil Tablets for Failed Dissolution and Stability Testing
FDA (Drugs) · 2026-09-02
- ModerateApotek desmopressin nasal spray recalled over dislodged or missing cap liners
FDA (Drugs) · 2026-04-22
- HighBrimonidine and timolol eye drops recalled over sterility assurance failure
FDA (Drugs) · 2026-03-25
- HighGlaucoma eye drops recalled over sterility assurance and bottle sealing concerns
FDA (Drugs) · 2025-10-08
Same hazard · mis labeling
See all →- High
- ModerateRecall of MPR Single Use Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModeratePercussionaire Recalls Intrapulmonary Percussive Ventilation Devices Due to Labeling Warning
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
- ModerateASP Global Recalls Disposable Tourniquet Cuffs Due to Incorrect Expiration Dates
FDA (Devices) · 2026-10-07
Similar recalls
- LowEnoxaparin Sodium Injection Recalled for Labeling Error on Declared Strength
FDA (Drugs) · 2018-01-17
- HighEnoxaparin syringe bags recalled after being labeled with the wrong strength
FDA (Drugs) · 2025-09-03
- HighEnoxaparin Sodium Injection recalled due to improper storage conditions
FDA (Drugs) · 2024-01-03
- ModerateFosinopril Sodium Tablets Recalled for Potential Labeling Error
FDA (Drugs) · 2014-01-22
- SevereSandoz Enoxaparin Sodium Injection Recalled Due to Temperature Excursion
FDA (Drugs) · 2021-12-08
- CriticalPharmakon Recalls Atropine Sulfate Syringes Due to Undeclared Benzyl Alcohol
FDA (Drugs) · 2014-09-03