---
title: Nivagen Pharmaceuticals Inc — FDA recall record
license: CC0-1.0
source: openFDA drug & device recall enforcement records — U.S. FDA
---

# Nivagen Pharmaceuticals Inc — FDA recall record

The FDA recall enforcement history of Nivagen Pharmaceuticals Inc: 1 recalls (0 Class I), drug/device split, severity mix, recurring reasons, and ongoing count. RECORDED openFDA records, keyed by the exact firm name. Not a quality verdict or medical advice. CC0.

## Claims

### Nivagen Pharmaceuticals Inc has 1 FDA recalls on record (2024–2024)

**DERIVED.** Nivagen Pharmaceuticals Inc has 1 FDA recall enforcement records (1 drug, 0 device), of which 0 are Class I (the FDA's most-serious tier), 1 Class II, 0 Class III; 1 are ongoing. An AGGREGATED count of openFDA enforcement records keyed by firm name (occurred=true; adjudged=FALSE — the Atlas counted them, the FDA published the records).

Source: openFDA drug & device recall enforcement records — U.S. FDA — https://open.fda.gov/
Falsifier: occurred=TRUE: a faithful COUNT/SUM/total over the named record set that introduces NO modeling choice — it IS the case in the record. adjudged=FALSE: Atlas Commons computed the aggregate; openFDA drug & device recall enforcement records — U.S. FDA published the underlying records, NOT this figure. Re-count it from the named source to verify. Distinct from a median/ratio/index (which picks a population, weighting, denominator, or threshold — a constructed statistic → 'derived', occurred=FALSE) and from an authority-published total (→ 'recorded', adjudged=TRUE).

### A recall count is not a quality verdict

**INTERPRETATION.** A recall count is not a quality verdict — large firms recall more by volume and most recalls are voluntary; the Class I count and ongoing status are the signal, not the raw total. Keyed by the exact firm-name string (a large firm may file under variants; see the FDA recall database for the complete cross-variant record). Not medical advice.

Source: Drug & Device Safety Atlas L5 boundary (recall count ≠ quality verdict) — https://drug-device-safety-atlas.ryanjhunter.workers.dev/
Falsifier: occurred=FALSE (a framing, not an event) and adjudged=FALSE (an in-house reading, not an authority's verdict) — the LOWEST-warrant claim here. A flat representation would render this identically to the official facts; the four-status does not.

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Every claim above carries a four-status warrant (RECORDED / MODELED / DERIVED / INTERPRETATION) and a named source you can re-fetch — this is a research object, not a flat fact. Structured: `https://drug-device-safety-atlas.ryanjhunter.workers.dev/recalls/firm/nivagen-pharmaceuticals-inc.jsonld`

## Data

### FDA recall summary — Nivagen Pharmaceuticals Inc

Aggregated counts of openFDA enforcement records keyed by firm name (occurred=true, adjudged=false — Atlas counted; FDA published the records). Source: openFDA.

| Metric | Value | Status |
| --- | --- | --- |
| Total recalls | 1 | aggregated |
| Drug recalls | 1 | aggregated |
| Device recalls | 0 | aggregated |
| Class I (most serious) | 0 | aggregated |
| Class II | 1 | aggregated |
| Class III | 0 | aggregated |
| Ongoing | 1 | aggregated |
| Year span | 2024–2024 | aggregated |
| Top reason #1 | Presence of Foreign Tablets/Capsules: A Carbamazepine Extended-Release 400 mg tablet was found in a 1000-count bottle of (1×) | aggregated |