Agency classClass IIOur severity:Severe FDA (Drugs)·D-0737-2021·Announced 2021-08-25

Leucovorin Calcium Injection Recalled Due to Sterility Concerns

Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection (350 mg/vial) distributed nationwide because the manufacturer cannot assure the product meets sterility standards.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

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 4/5 (Severe).

The hazard poses a serious risk of illness, injury, or structural failure. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: This is an FDA Class II recall involving a parenteral (injectable) pharmaceutical product. Loss of sterility assurance in injectable medications poses serious risk of infection and potential hospitalization, meeting the Severe classification criterion.

Plain-English summary

Teva Pharmaceuticals USA is recalling Leucovorin Calcium for Injection, USP 350 mg/vial in 17.5 mL single-use vials. The recall affects approximately 434,229 vials that were distributed nationwide, including Puerto Rico. The recall is due to a lack of assurance of sterility.

The affected lot numbers are: 31325852B, 31325985B (exp. 10/2021); 31326349B (exp. 01/2022); 31326873B (exp. 03/2022); 31326995B (exp. 05/2022); 31327158B (exp. 06/2022); and 31328946B and 31329180B (exp. 05/2023). The product is distributed under the manufacturer Teva Parenteral Medicines, Inc., Irvine, CA 92618.

Patients and healthcare providers in possession of affected lots should consult with a healthcare professional regarding appropriate next steps. The product is prescription-only and is identified by NDC 0703-5145-01.

The recalled product

Product: Leucovorin Calcium for Injection, USP 350 mg/vial, 17.5 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5145-01
Manufacturer: Teva Pharmaceuticals USA
Category: Drug — Injectable / Parenteral
Hazard: lack-of-sterility
contamination-risk
Affected units: 434,229

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 (13)

Lot #: 31325852B
31325985B
exp. date 10/2021
31326349B
exp. date 01/2022
31326873B
exp. date 03/2022
31326995B
exp. date 05/2022 31327158B
exp. date 06/2022
31328946B
31329180B
exp. date 05/2023.

Distribution

Distributed nationwide across the United States.

The notice also names 1 state specifically:

Part of a larger recall action

This product is one of 19 recalled by Teva Pharmaceuticals USA 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 19 products in this recall →

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · lack of sterility