Class II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications
Phenytoin Sodium Injection
Class III — Low risk. Unlikely to cause harm, but violates FDA regulations.
Why it was recalled
Labeling: Not elsewhere classified; the product is being recalled because of customer complaints that the primary vial label was missing a barcode.
Cause type: Labeling / mix-up
Wrong label, wrong strength, mixed-up products, or packaging errors. One of the most dangerous causes - you can end up taking the wrong drug or the wrong dose. All labeling / mix-up recalls.
What was recalled
Phenytoin Sodium Injection, USP, 250 mg/5 mL, NDC 42192-614-05, packaged in 10 x 5 mL vials per carton, NDC 42192-614-30, Rx only, Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30005
Affected NDCs
42192-0614-05
42192-0614-30
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 |
|---|---|---|---|---|
| Phenytoin Sodium NDC 42192-0614 |
50 mg/mL | Injection Intramuscular|intravenous |
Acella Pharmaceuticals, LLC | Rx |
- Recalling firm
- Acella Pharmaceuticals, LLC
- NDC code
- 42192-614-05
- Origin
- GA, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0070-2023 · FDA notice
Low risk, still worth a check. Class III means the product is unlikely to cause harm but breaks an FDA rule (often labeling). If your lot matches, your pharmacy will normally swap it; there is no need for alarm. 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 II · Moderate risk
Extended Phenytoin Sodium Capsules
Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)
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 Acella Pharmaceuticals, LLC
All 2022 recalls
Class II · Moderate risk
Naproxen Oral Suspension
Chemical contamination; presence of lead and lithium above specification
Class II · Moderate risk
Doxycycline Hyclate Tablets
Failed dissolution specifications: Stability testing found that the lot did not meet dissolution specifications.
Class III · Low risk
Sodium Sulfacetamide 10% - Sulfur 5% Cleanser
Subpotent drug
Class III · Low risk
Sodium Sulfacetamide 10% Sulfur 4% Cleansing Pads
Subpotent drug: Out of specification for assay at the end-of-shelf-life 24-month period.
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