Severity
Critical
CriticalClass ITerminated
FDA Drug recall · Reported August 14, 2013
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
Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Zydus Pharmaceuticals USA Inc recalled Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: C… - a critical-severity action.
Warfarin Sodium Tablets, USP 2 mg, Rx Only, 1000 Tablets per bottle, Manufactured by: C… was recalled by Zydus Pharmaceuticals USA Inc in August 14, 2013. Reason: Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that …. Check the official notice for the remedy. Verify recall #D-838-2013 with the FDA Drug before acting.
The recall
Zydus Pharmaceuticals USA Inc issued this critical-severity FDA Drug recall-Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that ….
- Critical
- severity level
- Class I
- classification
- August 14, 2013
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-838-2013 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-838-2013) was formally reported on August 14, 2013, with the manufacturer initiating the action on May 13, 2013. It is classified under Critical severity (Class I), with a current status of Terminated. Zydus Pharmaceuticals USA Inc is listed as the recalling firm, operating out of Pennington, NJ. Federal records list the affected scope as 960 Bottles.
The documented reason for this recall is: Failed Tablet/Capsule Specifications: A product complaint was received from a pharmacist who discovered that 3 tablets in a 1000-count bottle were oversized. Distribution data in the federal record shows the product reached: Nationwide. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
960 Bottles
Related Recalls
6
5 from same agency
Product description
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
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.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Terminated |
| Recall number | D-838-2013 |
| Date reported | August 14, 2013 |
| Date initiated | May 13, 2013 |
| Recalling firm | Zydus Pharmaceuticals USA Inc |
| Firm location | Pennington, NJ |
| Affected scope | 960 Bottles |
| Distribution | Nationwide |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-838-2013) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Zydus Pharmaceuticals USA Inc. Units affected: 960 Bottles.
Why was this product 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 agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2013. Severity: Critical. Recall number: D-838-2013.
Where was the recalled product distributed? ▼
Distribution: Nationwide.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-838-2013) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported August 14, 2013. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.