CLASS II Drug recall · Reported 1 Mar 2023 · FDA Enforcement Report
Warfarin Sodium Tablets, USP 1 mg recalled by Rising Pharmaceuticals
Rising Pharmaceuticals is recalling Warfarin Sodium Tablets, USP 1 mg, distributed nationwide in the US. The recall was initiated on 15 Feb 2023 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-0348-2023
- FDA event ID
- 91713
- Recalling firm
- Rising Pharmaceuticals, East Brunswick, NJ
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 15 Feb 2023
- FDA classified
- 23 Feb 2023
- Reported
- 1 Mar 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Thinners
Timeline
| 15 Feb 2023 | Recall initiated by company | |
| 23 Feb 2023 | Classified by FDA | +8 days |
| 1 Mar 2023 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Failed Impurities/Degradation Specifications
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Warfarin Sodium Tablets, USP 1 mg, 100-count bottle, Rx Only, Distributed by: Rising Health, LLC, Saddle Brook, NJ 07663, NDC# 57237-119-01
Where it was distributed
Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
Questions about this recall
Is Warfarin Sodium Tablets, USP 1 mg recalled?
Yes. Rising Pharmaceuticals recalled Warfarin Sodium Tablets, USP 1 mg on 15 Feb 2023. The recall is Class II and its status is Terminated. Recall number D-0348-2023.
Why was it recalled?
Failed Impurities/Degradation Specifications
Which lots are affected?
Batch #: NB101596, Exp. 04/30/2023
Where was it sold?
Product was distributed to 16 distributors and 8 wholesalers who may have further distributed the product nationwide.
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 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.
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|---|---|---|---|---|---|
| Drug | CLASS II | Methylphenidate Hydrochloride Chewable Tablets, 5 mg recalledMethylphenidate Hydrochloride | Rising Pharmaceuticals | Packaging Defects | Nationwide |
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| Drug | CLASS III | Timolol Maleate Sterile Opthalmic Solution recalledTimolol Maleate | Rising Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS III | Timolol Maleate USP, 5%, Sterile Opthalmic Solution recalledTimolol Maleate | Rising Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Valsartan Tablets 160 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Nitrosamine Impurity | Nationwide |
Other Warfarin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Warfarin Sodium Tablets, USP, 5 mg recalled by Cardinal HealthcareWarfarin Sodium | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Warfarin Sodium Tablets, USP, 5 mg recalled by Cardinal HealthcareWarfarin Sodium | Cardinal Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS III | Warfarin Sodium Tablets, USP Crystalline, 2 mg recalledWarfarin Sodium | Taro Pharmaceuticals U.S.A | Other | 7 states |
| Drug | CLASS II | Warfarin Sodium Tablet, 5 mg (1/2 of 1 mg) recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Warfarin Sodium Tablet, 5 mg (1/2 of 1 mg) recalled by Aidapak Services | Aidapak Services | Labeling Errors | 4 states |