Adenosine Injection Recalled for Lack of Sterility Assurance
Teva Pharmaceuticals USA is recalling Adenosine Injection (60 mg/20 mL vials) nationwide due to lack of assurance of sterility, which could pose a serious health risk if the product is not sterile.
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: This is an FDA Class II recall of an injectable pharmaceutical product with a sterility defect. Injectable products administered intravenously carry inherent risk of serious infection if contaminated, meeting the criteria for a Severe rating even without reported illnesses, because the hazard directly threatens patient safety in a high-risk route of administration.
Plain-English summary
Teva Pharmaceuticals USA is recalling Adenosine Injection, USP, 60 mg/20 mL (3 mg/mL) single-dose vials (NDC 16714-180-01) nationwide, including Puerto Rico. Lot #100022401 with expiration date 04/2023 is affected. Approximately 20,800 vials were distributed.
The recall was initiated because the manufacturer cannot assure that the product meets sterility requirements. Adenosine Injection is administered intravenously to patients; use of a non-sterile injectable product could result in serious infection or other adverse health consequences.
Healthcare providers, pharmacists, and patients should discontinue use of affected vials. Vials should not be dispensed or administered. Customers in possession of affected product should contact Teva Pharmaceuticals USA or their pharmaceutical supplier for instructions on return or destruction. Patients who may have received this product should consult their healthcare provider.
The recalled product
- Product
- Adenosine Injection, USP, 60mg/20 mL (3 mg/mL), 20 mL single-dose vial, Rx only, Mfd in the USA for: NorthStar Rx LLC Memphis, TN 38141, NDC 16714-180-01
- Manufacturer
- Teva Pharmaceuticals USA
- Category
- Drug — Injectable / Intravenous
- Hazard
- sterility-defect
- infection-risk
- contamination
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 #: 100022401
- exp. date 04/2023
Distribution
Distributed nationwide across the United States.
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