# FDA enforcement report D-0541-2026

> FDA's dated enforcement report D-0541-2026 lists Class II and source status Ongoing for Lupin Pharmaceuticals Inc. PeptideScanner connects the report to reviewed application ANDA215421 through exact openFDA application-number annotations.

- Evidence object: `story:fda-enforcement-d-0541-2026:v1`
- Evidence domain: Safety
- Date in source: 2026-05-27
- Source checked: 2026-08-25
- Published by PeptideScanner: 2026-08-25
- Story landing page: https://peptidescanner.com/stories/fda-enforcement-d-0541-2026/
- JSON record: https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-0541-2026-v1.json
- Content SHA-256: `ab99086cf26a4665a6098a2c81143f71a64b082ff4781b35d04bbf36c1942f4a`

## Claims and source pins

### Headline

FDA enforcement report D-0541-2026 ([`fda-enforcement-d-0541-2026-bc599cdc32eb`](#source-fda-enforcement-d-0541-2026-bc599cdc32eb))

### Summary

FDA's dated enforcement report D-0541-2026 lists Class II and source status Ongoing for Lupin Pharmaceuticals Inc. PeptideScanner connects the report to reviewed application ANDA215421 through exact openFDA application-number annotations. ([`fda-enforcement-d-0541-2026-bc599cdc32eb`](#source-fda-enforcement-d-0541-2026-bc599cdc32eb))

### Paragraph 1

FDA's dated enforcement report D-0541-2026 lists Class II and source status Ongoing for Lupin Pharmaceuticals Inc. PeptideScanner connects the report to reviewed application ANDA215421 through exact openFDA application-number annotations. ([`fda-enforcement-d-0541-2026-bc599cdc32eb`](#source-fda-enforcement-d-0541-2026-bc599cdc32eb))

### Paragraph 2

FDA's source-reported reason is: Presence of particulate matter: a white thread-like structure in the cartridge ([`fda-enforcement-d-0541-2026-bc599cdc32eb`](#source-fda-enforcement-d-0541-2026-bc599cdc32eb))

### Paragraph 3

This PeptideScanner lane is a bounded, dated FDA enforcement-report snapshot connected through an exact openFDA application-number annotation. It is not a medical alert or complete recall-lifecycle tracker, does not establish current product or recall status, does not identify affected lots, and does not provide medical guidance. ([`fda-enforcement-d-0541-2026-bc599cdc32eb`](#source-fda-enforcement-d-0541-2026-bc599cdc32eb))

## Sources

<a id="source-fda-enforcement-d-0541-2026-bc599cdc32eb"></a>
- **FDA enforcement report D-0541-2026 · Class II · report date 2026-05-27 · source status Ongoing** — FDA enforcement reports via openFDA; class A. [Open source](https://api.fda.gov/drug/enforcement.json?search=recall_number%3A%22D-0541-2026%22&limit=1) (`fda-enforcement-d-0541-2026-bc599cdc32eb`)

## Correction lineage

No correction is recorded for this version.

## Reporting boundaries and unknowns

PeptideScanner reports the cited safety or enforcement record. It is not an individualized risk assessment or medical recommendation.

- Sources outside the selected public PeptideScanner bundle may exist and are not represented by this object.
- This object does not determine whether cited records agree, corroborate one another, or establish scientific truth.
- This object does not determine safety, efficacy, causality, or suitability for any person.

Methodology: https://peptidescanner.com/methodology/
Medical disclaimer: https://peptidescanner.com/medical-disclaimer/

## Suggested citation

PeptideScanner. "FDA enforcement report D-0541-2026." Version 1, published 2026-08-25. https://peptidescanner.com/evidence/v1/objects/fda-enforcement-d-0541-2026-v1.json SHA-256: ab99086cf26a4665a6098a2c81143f71a64b082ff4781b35d04bbf36c1942f4a.