Severity
Moderate
ModerateClass IITerminated
FDA Drug recall · Reported August 8, 2012
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
West-ward Pharmaceutical Corp. recalled Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dos… - a moderate-severity action.
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dos… was recalled by West-ward Pharmaceutical Corp. in August 8, 2012. Reason: Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stabi…. Check the official notice for the remedy. Verify recall #D-1437-2012 with the FDA Drug before acting.
The recall
West-ward Pharmaceutical Corp. issued this moderate-severity FDA Drug recall-Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stabi….
- Moderate
- severity level
- Class II
- classification
- August 8, 2012
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-1437-2012 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-1437-2012) was formally reported on August 8, 2012, with the manufacturer initiating the action on April 13, 2012. It is classified under Moderate severity (Class II), with a current status of Terminated. West-ward Pharmaceutical Corp. is listed as the recalling firm, operating out of Eatontown, NJ. Federal records list the affected scope as a) 308,275 vials; b) 2,008,850 vials.
The documented reason for this recall is: Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples. Distribution data in the federal record shows the product reached: All lots were distributed throughout the US.. 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 moderate severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
a) 308,275 vials; b) 2,008,850 vials
Related Recalls
6
5 from same agency
Product description
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).
Reason for recall
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Moderate (Class II) |
| Status | Terminated |
| Recall number | D-1437-2012 |
| Date reported | August 8, 2012 |
| Date initiated | April 13, 2012 |
| Recalling firm | West-ward Pharmaceutical Corp. |
| Firm location | Eatontown, NJ |
| Affected scope | a) 308,275 vials; b) 2,008,850 vials |
| Distribution | All lots were distributed throughout the US. |
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-1437-2012) 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.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. 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? ▼
Fosphenytoin Sodium Injection, USP, 100 mg PE per 2 mL (50 mg PE per mL), 2 mL Single Dose Vial, packaged in 25-count x 2 mL Single Dose Vials per carton, Rx only, Mfd. By: Hikma Farmaceutica (Portugal), S.A.; Dist. By: West-Ward Pharmaceutical Corp., Eatontown, NJ 07724 USA under the labels a) NOVAPLUS (NDC 0143-9704-25), b) West-Ward (NDC 0143-9788-25).. Recalled by West-ward Pharmaceutical Corp.. Units affected: a) 308,275 vials; b) 2,008,850 vials.
Why was this product recalled? ▼
Presence of Particulate Matter: This product is being recalled due to the discovery of particles in the stability samples and retain samples.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 8, 2012. Severity: Moderate. Recall number: D-1437-2012.
Where was the recalled product distributed? ▼
Distribution: All lots were distributed throughout the US..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-1437-2012) 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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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 8, 2012. 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.