CLASS II Drug recall · Reported 3 Mar 2021 · FDA Enforcement Report
Leucovorin Calcium for Injection, USP, 350 mg/vial recalled
Teva Pharmaceuticals USA is recalling Leucovorin Calcium for Injection, USP, 350 mg/vial, distributed nationwide in the US. The recall was initiated on 10 Feb 2021 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0285-2021
- FDA event ID
- 87298
- Recalling firm
- Teva Pharmaceuticals USA, Parsippany, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 10 Feb 2021
- FDA classified
- 21 Feb 2021
- Reported
- 3 Mar 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Sterility
- Drug class
- Injectable & IV Drugs
Timeline
| 10 Feb 2021 | Recall initiated by company | |
| 21 Feb 2021 | Classified by FDA | +11 days |
| 3 Mar 2021 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
A sterility recall means a product that must be sterile, such as an injection or eye drop, may be contaminated. Using a non-sterile product can cause serious infection.
Product as listed by the FDA
Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Teva Parenteral Medicines, Inc., Irvine, CA 92618, and b) Manufactured By: Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, novaplus+, NDC 0703-5145-01.
Where it was distributed
Product was distributed nationwide in the USA and Puerto Rico.
Questions about this recall
Why was it recalled?
Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance levels for microbial recovery leading to a lack of sterility assurance for these sterile injectable products.
Which lots are affected?
Lot # a) 31324653B, exp. date 03/2021; 31326066B, exp. date 11/2021; 31326428B, exp. date 02/2022; 31327949B, exp. date 10/2022; 31327995B, exp. date 10/2022; 31328031B, exp. date 11/2022; 31328217B, exp. date 12/2022; 31328325B, exp. date 12/2022; 31328425B, exp. date 07/2021; Lot # b) 31324480B, exp. date 02/2021; Lot # 31327396B, exp. date 08/2022
Where was it sold?
Product was distributed nationwide in the USA and Puerto Rico.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
14 other products · FDA event 87298This product is part of a recall event; the main page for the event is Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng) vial recalled.
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|---|---|---|---|---|---|
| Drug | CLASS II | traZODone Hydrochloride Tablets, USP, 50 mg recalledTrazodone Hydrochloride | Teva Pharmaceuticals USA | Other | Nationwide |
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| Drug | CLASS II | Isotretinoin Capsules, USP, 30 mg recalled by Teva Pharmaceuticals USAIsotretinoin | Teva Pharmaceuticals USA | Potency & Assay | 4 states |
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Other Leucovorin recalls
All 13| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 100 mg/vial single-use vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals USA | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial recalled | Teva Pharmaceuticals USA | Sterility | Nationwide |