Pfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns
Pfizer is recalling 12,416 vials of Elelyso (taliglucerase alfa) because loose metal ferrule crimps may compromise 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 recall is classified as FDA Class II and involves a lack of assurance of sterility for an injectable drug, which poses a significant risk of serious injury or infection.
Plain-English summary
Pfizer Inc. is recalling 12,416 vials of Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, NDC 0069-0106-01. The recall is limited to Lot S91616. The product is distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017.
The recall was initiated due to reports of loose metal ferrule crimps on the vials for injection. Specifically, the entire cap either lifted or dislodged while attempting to flip off the orange color plastic button. This defect raises a lack of assurance of sterility for the affected product.
The product was distributed nationwide in the U.S.A. Additionally, product from Lot S91616 was distributed to Albania, South Africa, Israel, Afghanistan, Rwanda, Botswana, Zimbabwe, and Iraq as part of the Compassionate Use Program. Patients and healthcare providers should stop using the affected vials and contact Pfizer or their healthcare provider for further instructions.
The recalled product
- Product
- ELELYSO (TALIGLUCERASE ALFA)
- Brand
- ELELYSO
- Manufacturer
- Pfizer Inc.
- Category
- Drug — Prescription Injectable
- Affected units
- 12,416
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)
- Lot S91616
Distribution
Distributed nationwide across the United States.
Related recalls
Same brand · ELELYSO
- SeverePfizer Recalls Elelyso Vials Due to Sterility Assurance Concerns
FDA (Drugs) · 2020-03-11
Same manufacturer · Pfizer Inc.
See all →- HighSodium bicarbonate injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighEpinephrine injection vials recalled for lack of assurance of sterility
FDA (Drugs) · 2025-08-27
- HighBicillin L-A 2.4 million unit vials recalled after particulates found
FDA (Drugs) · 2025-08-06
- HighBicillin L-A penicillin vials recalled after particulates found during visual inspection
FDA (Drugs) · 2025-08-06
- ModerateDobutamine Injection Recall Due to Discoloration and Cracked Vials
FDA (Drugs) · 2025-07-02
Same hazard · sterility
See all →- SevereRegeneron Recalls Libtayo Injection Due to Sterility Assurance Concerns
FDA (Drugs) · 2026-08-26
- SeverePrestige Recalls Clear Eyes Maximum Itchy Eye Relief Due to Sterility Concerns
FDA (Drugs) · 2026-08-19
- SevereROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- HighROHTO Cooling Eye Drops Recalled Over Sterility Assurance Concerns
FDA (Drugs) · 2026-07-29
- SevereFDA Recalls ROHTO OPTIC GLOW Eye Drops Over Sterility Concerns
FDA (Drugs) · 2026-07-29