Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
Extended Phenytoin Sodium Capsules
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
Cause type: Dissolution failure
The tablet or capsule did not dissolve within specification. Dissolution controls how much drug the body absorbs; a failure can change the effective dose. All dissolution failure recalls.
What was recalled
Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distributed by: Amneal Pharmaceuticals LLC., Bridgewater, NJ 08807, NDC 65162-212-10.
Affected NDC
65162-0212-10
Compare with the code on your package — it is the most precise check available.
Drug: Phenytoin
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Extended Phenytoin Sodium Phenytoin Sodium NDC 65162-0212 |
100 mg/1 | Capsule Oral |
Amneal Pharmaceuticals LLC | Rx |
- Recalling firm
- Amneal Pharmaceuticals of New York, LLC
- NDC code
- 65162-212-10
- Origin
- NY, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0876-2023 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Phenytoin recalls
See all
Class I · High risk
Phenytoin Oral Suspension
Failed Content Uniformity Specifications
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class III · Low risk
Phenytoin Sodium Injection
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Class I · High risk
Phenytoin Oral Suspension USP
Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may not resuspend as per the label copy instructions.
Other recalls by Amneal Pharmaceuticals of New York, LLC
All 2023 recalls
Class II · Moderate risk
Exenatide Injection
Defective Delivery System: Possibility of no medication in the prefilled pen.
Class II · Moderate risk
Methylergonovine Maleate Tablets
Failed Dissolution Specifications
Class I · High risk
Vancomycin Hydrochloride for Oral Solution
Superpotent Drug: Due to overfilling of drug powder
Class II · Moderate risk
Oseltamivir Phosphate for Oral Suspension 6mg/ml
Failed Impurities/Degradation Specifications: Out-of-specification test results.
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