The Recall Desk
SevereFDA (Drugs)·D-0746-2021·Announced 2021-08-25

Leucovorin Calcium for Injection Recalled Due to Sterility Assurance Concerns

Teva Pharmaceuticals is recalling Leucovorin Calcium for Injection in 100 mg/vial 10 mL single-use vials due to lack of assurance of sterility. The recall affects approximately 476,275 vials distributed nationwide, including Puerto Rico.

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 a parenteral injection with sterility assurance defects. Parenteral products lacking sterility assurance pose significant risk of serious infection or harm; this meets the Class II criterion for severe severity even without reported hospitalizations explicitly documented in the notice.

Plain-English summary

Teva Pharmaceuticals USA is recalling Leucovorin Calcium for Injection, USP 100 mg/vial in 10 mL single-use vials (NDC 0703-5140-01) due to lack of assurance of sterility. The product is a prescription injectable medication manufactured by Teva Parenteral Medicines, Inc. in Irvine, California.

Approximately 476,275 vials have been distributed nationwide, including Puerto Rico. The affected lots are: 31325596B (expiration date 08/2021), 31328129B (expiration date 11/2022), 31328356B (expiration date 01/2023), 31329297B (expiration date 06/2023), and 31329569B and 31329821B (expiration date 08/2023).

Patients who have received this product should contact their healthcare provider. Healthcare providers should quarantine remaining product and return it to Teva Pharmaceuticals according to the company's recall instructions.

The recalled product

Product
Leucovorin Calcium for Injection, USP 100 mg/vial, 10 mL single-use vials, Rx only, Teva Parenteral Medicines, Inc. Irvine, CA 92618, NDC 0703-5140-01
Manufacturer
Teva Pharmaceuticals USA
Category
Drug — Injectable / Parenteral
Hazard
Affected units
476,275

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 (11)

  • Lot #: 31325596B
  • exp. date 08/2021
  • 31328129B
  • exp. date 11/2022
  • 31328356B
  • exp. date 01/2023
  • 31329297B
  • exp. date 06/2023
  • 31329569B
  • 31329821B
  • exp. date 08/2023

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 →

Related recalls

Same manufacturer · Teva Pharmaceuticals USA

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Same hazard · sterility assurance

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