CLASS III Drug recall · Reported 19 Aug 2020 · FDA Enforcement Report
Leucovorin Calcium Tablets USP, 10 mg recalled by West-Ward Columbus
West-Ward Columbus is recalling Leucovorin Calcium Tablets USP, 10 mg, distributed in Mississippi, Ohio. The recall was initiated on 22 Jul 2020 and the FDA has classified it as Class III.
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-1490-2020
- FDA event ID
- 86079
- Recalling firm
- West-Ward Columbus, Columbus, OH
- Brand
- Leucovorin Calcium
- Manufacturer
- Hikma Pharmaceuticals USA Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 22 Jul 2020
- FDA classified
- 7 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
Timeline
| 22 Jul 2020 | Recall initiated by company | |
| 7 Aug 2020 | Classified by FDA | +16 days |
| 19 Aug 2020 | Published in enforcement report | +12 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Product as listed by the FDA
Leucovorin Calcium Tablets USP, 10 mg, Rx only, 24 Tablets per bottle, Distr. by: West-Ward Pharmaceuticals Corp. Eatontown, NJ 07724, NDC 0054-4497-10
Where it was distributed
OH and MS
Questions about this recall
Is Leucovorin Calcium Tablets USP, 10 mg recalled?
Yes. West-Ward Columbus recalled Leucovorin Calcium Tablets USP, 10 mg on 22 Jul 2020. The recall is Class III and its status is Terminated. Recall number D-1490-2020.
Why was it recalled?
Failed Tablet/Capsule Specifications: Tablets are imprinted with the incorrect identification code.
Which lots are affected?
Lot: #064046A, Exp. 03/2022
Where was it sold?
OH and MS
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 III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from West-Ward Columbus
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|---|---|---|---|---|---|
| Drug | CLASS III | Methadone Hydrochloride Tablets, USP, 5mg, Unit-Dose Tablets recalledMethadone Hydrochloride | West-Ward Columbus | Other | Nationwide |
| Drug | CLASS III | Methotrexate Tablets, USP, 5 mg, Unit-Dose Tablets recalledMethotrexate Sodium | West-Ward Columbus | Other | MS, OH |
| Drug | CLASS II | Doxycycline Hyclate Tablets USP, 100 mg recalled by West-Ward ColumbusDoxycycline Hyclate | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS III | Ethacrynic Acid Tablets USP, 25 mg recalled by West-Ward Columbus | West-Ward Columbus | Potency & Assay | Nationwide |
| Drug | CLASS II | Oxcarbazepine Oral Suspension, USP, 300 mg recalled | West-Ward Columbus | Potency & Assay | Nationwide |
Other Leucovorin recalls
All 11| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 100 mg/vial single-use vials recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP 350 mg/vial single-use vials recalled | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection recalled by Teva Pharmaceuticals U | Teva Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial recalled | Teva Pharmaceuticals U | Sterility | Nationwide |