CLASS I Drug recall · Reported 14 Aug 2013 · FDA Enforcement Report
Warfarin Sodium Tablets, USP 2 mg recalled by Zydus Pharmaceuticals USA
Zydus Pharmaceuticals USA is recalling Warfarin Sodium Tablets, USP 2 mg, distributed nationwide in the US. The recall was initiated on 13 May 2013 and the FDA has classified it as Class I.
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-838-2013
- FDA event ID
- 65394
- Recalling firm
- Zydus Pharmaceuticals USA, Pennington, NJ
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 13 May 2013
- FDA classified
- 2 Aug 2013
- Reported
- 14 Aug 2013
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Other Reasons
- Drug class
- Blood Thinners
Timeline
| 13 May 2013 | Recall initiated by company | |
| 2 Aug 2013 | Classified by FDA | +81 days |
| 14 Aug 2013 | 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: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Product as listed by the FDA
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc., Pennington, NJ 08534, NDC 68382-053-10
Where it was distributed
Nationwide
Questions about this recall
Why was it recalled?
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Which lots are affected?
Lot MM5767
Where was it sold?
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
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 Zydus Pharmaceuticals USA
All 41| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ethacrynate Sodium for Injection, USP, 50mg/vial, Single Dose Vial recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 1 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | MethylPREDNISolone Tablets, USP 32 mg recalledMethylprednisolone | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.25 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pramipexole Dihydrochloride Tablets 0.125 mg recalled | Zydus Pharmaceuticals USA | Manufacturing (CGMP) Deviations | 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 III | Warfarin Sodium Tablets, USP Crystalline, 2 mg recalledWarfarin Sodium | Taro Pharmaceuticals U | Other | 7 states |
| Drug | CLASS II | Warfarin Sodium Tablet, 0.5 mg (1/2 of 1 mg) recalled | Aidapak Services | Labeling Errors | 4 states |