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.

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Recall #: D-0876-2023
Affected scope: 9,056 bottles
Initiated: May 30, 2023

Compiled from official public sources by the publisher. · Updated September 2026

Amneal Pharmaceuticals of New York, LLC recalled Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distri… - a moderate-severity action.

Extended Phenytoin Sodium Capsules, USP, 100 mg, Rx Only, 100 capsules per bottle, Distri… was recalled by Amneal Pharmaceuticals of New York, LLC in June 21, 2023. Reason: Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification). Check the official notice for the remedy. Verify recall #D-0876-2023 with the FDA Drug before acting.

The recall

Amneal Pharmaceuticals of New York, LLC issued this moderate-severity FDA Drug recall-Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification).

Moderate
severity level: Class II
classification: June 21, 2023
reported

Sourced from official FDA Drug enforcement records. Verify recall #D-0876-2023 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.

Recall Insight

This recall's affected scope, documented in the Recall Profile below, stays within a single-region or limited-distribution footprint. Distribution scope (see Distribution below) 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, 1 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.

Where this agency-classified recall sits among FDA Class I/II/III notices

Of 88,244 recalls with an agency hazard classification, 19,068 are high severity, 64,652 moderate, and 4,524 low. A further 16,179 CPSC/NHTSA recalls have no agency class and are excluded from this split. 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.

Product description

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.

Reason for recall

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Recall Profile

Structured summary of the FDA Drug recall record
Attribute	Value
Agency	U.S. Food and Drug Administration
Severity class	Moderate (Class II)
Status	Terminated
Recall number	D-0876-2023
Date reported	June 21, 2023
Date initiated	May 30, 2023
Recalling firm	Amneal Pharmaceuticals of New York, LLC
Firm location	Brookhaven, NY
Affected scope	9,056 bottles
Distribution	LA, PA and OH.

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-0876-2023) 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? ▼

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.. Recalled by Amneal Pharmaceuticals of New York, LLC. Units affected: 9,056 bottles.

Why was this product recalled? ▼

Failed Dissolution Specifications: Out-of-specification results for dissolution (above specification)

Which agency issued this recall? ▼

This recall was issued by the FDA Drug on June 21, 2023. Severity: Moderate. Recall number: D-0876-2023.

Where was the recalled product distributed? ▼

Distribution: LA, PA and OH..

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.

Nationwide recalls with similar severity or category timing

Drug and device notices outside this firm and state, matched by severity timing and product category.

Similar severity · nearest report date

Same archive severity grade (Moderate), closest by report date among other firms and states.

Isopropyl Alcohol Antiseptic 75%, Topical… 2023-06-21 Texas Pete BUFFALO Wing Sauce 12 FL OZ - … 2023-06-21 Recalled product has the carton labeled a… 2023-06-21 p-Chip Wand Reader 2023-06-21

Similar Children & Baby Products · nearest report date

Same product category, closest by report date among other firms and states (deduped against the severity set).

Lysteda (tranexamic acid) USP Tablets, 65… 2023-06-21 Alcohol Antiseptic 80%, Topical Solution,… 2023-06-21 SOFT HANDS Alcohol Antiseptic 80%, Topica… 2023-06-21 Zuru Recalls 7.5 Million Baby Shark and M… 2023-06-22

Compare this recall with CLEAR EYES Maximum Itchy Eye Relief, 0.5 fl oz (15 mL) per … → · All Children & Baby Products recalls

This recall: FDA Drug, reported June 21, 2023. Severity classes follow each agency's own taxonomy; related-recall context is computed across the full archive.

Methodology · Corrections · Archive as of August 2026