CLASS III Drug recall · Reported 24 Sep 2014 · FDA Enforcement Report
Warfarin Sodium Tablets, USP Crystalline, 2 mg recalled
Taro Pharmaceuticals U is recalling Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100, distributed in 7 states. The recall was initiated on 25 Aug 2014 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-1584-2014
- FDA event ID
- 69075
- Recalling firm
- Taro Pharmaceuticals U, Hawthorne, NY
- Brand
- Warfarin Sodium
- Manufacturer
- Sun Pharmaceutical Industries, Inc.
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 25 Aug 2014
- FDA classified
- 12 Sep 2014
- Reported
- 24 Sep 2014
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Thinners
Timeline
| 25 Aug 2014 | Recall initiated by company | |
| 12 Sep 2014 | Classified by FDA | +18 days |
| 24 Sep 2014 | 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 Content Uniformity Specifications.
Product as listed by the FDA
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3.
Where it was distributed
United States including: OH, HI, NH, MS, IL, TX, CA.
Questions about this recall
Why was it recalled?
Failed Content Uniformity Specifications.
Which lots are affected?
Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
Where was it sold?
United States including: OH, HI, NH, MS, IL, TX, CA.
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 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.
More recalls from Taro Pharmaceuticals U
All 36| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Hydrocortisone 1% & Acetic Acid 2% Otic Solution recalled | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS III | Clotrimazole and Betamethasone Dipropionate Cream recalledClotrimazole And Betamethasone Dipropionate | Taro Pharmaceuticals U | Potency & Assay | NY |
| Drug | CLASS I | Clobetasol Propionate Ointment USP, 0.05% tubes recalledClobetasol Propionate | Taro Pharmaceuticals U | Sterility | Nationwide |
| Drug | CLASS II | Nortriptyline HCl Capsules, USP equivalent to 10mg base recalledNortriptyline Hydrochloride | Taro Pharmaceuticals U | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | H-e-b - Athlete's Foot Cream Clotrimazole Cream USP, 1% Anitfungal recalledHEB | Taro Pharmaceuticals U | Potency & Assay | Nationwide |
Other Warfarin recalls
All 7| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Warfarin Sodium Tablets, USP, 2.5 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 II | Warfarin Sodium Tablets, USP 1 mg recalled by Rising Pharmaceuticals | Rising Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Warfarin Sodium Tablet, 0.5 mg (1/2 of 1 mg) recalled | Aidapak Services | Labeling Errors | 4 states |
| Drug | CLASS II | Warfarin Sodium Tablet, 0.5 mg (1/2 of 1 mg) recalled | Aidapak Services | Labeling Errors | 4 states |