GlaxoSmithKline Recalls Sumatriptan Injection Cartridges Due to Sterility Concerns
GlaxoSmithKline is recalling 9,743 cartridges of Sumatriptan Succinate Injection because some may have needles protruding through the shield, compromising sterility.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classified this as an FDA Class II recall. Per the rubric, an FDA Class II recall involving a significant safety defect (sterility compromise) is categorized as Severe.
Plain-English summary
GlaxoSmithKline, LLC. is recalling 9,743 cartridges of Sumatriptan Succinate Injection, 6 mg, 0.5 mL. The product is intended for subcutaneous injection and is distributed nationwide. The specific lot number is C636242, with an expiration date of 06/15.
The recall was initiated due to a lack of assurance of sterility. A small number of the pre-filled syringes may contain needles that protrude through the needle shield. This defect poses a risk to the sterility of the injection.
Consumers and healthcare providers should stop using the affected product and contact their healthcare provider or the recalling firm for further instructions.
The recalled product
- Product
- Sumatriptan Succinate Injection, 6 mg, 0.5 mL For subcutaneous injection only, Rx only, 2 Single-Dose Syringe Cartridges for use with sumatriptan Autoinjector Pen, Manufactured by GlaxoSmithKline, Research Triangle Park, NC 27709 for Sandoz Inc., Princeton, NJ 08540, Made in Sing
- Manufacturer
- GlaxoSmithKline, LLC.
- Category
- Drug — Injectable Medication
- Affected units
- 9,743
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 (2)
- Lot#: C636242
- Exp: 06/15
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 2 recalled by GlaxoSmithKline, LLC. 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 · GlaxoSmithKline, LLC.
See all →- ModerateTIVICAY HIV medication carton mislabeled with incorrect expiration date
FDA (Drugs) · 2024-06-12
- ModerateAnoro Ellipta inhalation powder recalled for failed release testing defect
FDA (Drugs) · 2024-01-03
- ModerateDrug Recall: Tivicay Tablets with Incorrect Expiration Date on Label
FDA (Drugs) · 2022-06-01
- HighGlaxoSmithKline Recalls Ventolin HFA Inhalers Due to Defective Delivery System
FDA (Drugs) · 2017-05-31
- ModerateGlaxoSmithKline Recalls Ventolin Inhalers Due to Defective Delivery System
FDA (Drugs) · 2017-04-12
Same hazard · sterility compromise
See all →- SevereSpectra Medical Devices Recalls Sodium Chloride Injection Ampules Due to Sterility Concerns
FDA (Devices) · 2026-08-19
- HighStryker Recalls Ahto Dual Spike Tube Set Due to Leaking Handpiece
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- ModerateIntramedullary Bone Saw Blade Assembly Recalled Due to Potential Sterile Barrier Damage
FDA (Devices) · 2026-08-12
- HighIntramedullary Bone Saw Blade Assemblies Recalled Due to Potential Packaging Damage
FDA (Devices) · 2026-08-12