Filler import refusal lines hit a 12-year high

Summary

FDA’s legacy Import Refusal Report files record 476 refused import lines under dermal-filler product code 79LMH in FY2026. That is the highest annual total in the available FY2015–FY2026 series and 2.51 times the previous high of 190 in FY2024. The FY2026 comparison uses records dated through September 24, 2026.

The historical record remains when records with literal “XXX-” entry identifiers are excluded. That sensitivity check produces 351 refused import lines in FY2026, compared with the previous high of 177 in FY2024—approximately double.

These are counts of refused import lines within a defined public-record series. They do not establish how much filler entered the market, the prevalence of counterfeiting, or a rate of patient harm.

The practical value is understanding what public records can verify, what purchasing documentation can establish, and where those checks stop.

Key findings

• A historical high under the primary rule: The FY2026 total of 476 refused import lines exceeds every earlier annual total in the available FY2015–FY2026 legacy series.
• A substantial gap above the previous high: The previous peak was 190 refused import lines in FY2024. The latest total is 2.51 times that level.
• The finding survives the alternative counting rule: Excluding literal “XXX-” entries leaves 351 refused import lines versus the previous high of 177.
• The previous year was below the previous peak: FY2025 recorded 178 refused import lines, compared with 190 in FY2024. The historical comparison therefore provides a stronger benchmark than the preceding year alone.
• Separate dashboard context points to documentation questions: In the distinct FY2026 dashboard cohort, the most common individual charge was “NOT LISTED,” recorded on 232 of 365 dashboard-listed refused import lines. This charge concerns required listing, notification or other information.

The historical FY2026 findings above use records dated through September 24, 2026. The dashboard findings use a separate snapshot and denominator.

The historical comparison

Annual refused import lines in FDA’s legacy files

Source: Independent reproduction of FDA’s legacy Import Refusal Report files, retrieved October 27, 2026. Exact product code: 79LMH. FY2026 includes records dated through September 24, 2026.

The series does not show a continuous annual increase. It includes an earlier rise in FY2018, a higher peak in FY2024, and a lower total in FY2025 before the latest record.

The primary previous-peak comparison is:

476 ÷ 190 = 2.505263…, reported as 2.51 times the previous high.

The sensitivity comparison is:

351 ÷ 177 = 1.983051…, reported as 1.98 times the previous high, or roughly double.

“Roughly double” describes the sensitivity comparison. The primary comparison is approximately two and a half times the previous high.

What a refused import line means

The analysis counts administrative records of refused import lines. A qualifying record is identified by its entry number, reference-document identifier, line number and line suffix. FDA’s dashboard field definitions use the same components for its full line identifier.

The historical dataset is restricted to exact import product code 79LMH. Its legacy description is “IMPLANT, DERMAL, COLLAGEN FOR AESTHETIC USE.” FDA’s current LMH device classification uses the broader description “implant, dermal, for aesthetic use” and identifies PMA as its submission pathway. The analysis follows the recorded code; it does not assume that every included record concerns collagen filler.

The cohort does not represent every possible filler classification or all FDA import-refusal activity.

An appearance in the refusal records also does not establish the authenticity of a physical item, identify the complete distribution chain, or support a general judgment about a listed establishment.

Separate dashboard findings: charges and concentration

This section uses dashboard-listed refused import lines, not the historical legacy-file series.

The dashboard cohort contains 151 refused import lines in FY2025 and 365 in FY2026. These figures were retrieved October 27, 2026, using exact product code 79LMH and separate fiscal-year filters. They are not substituted into the historical comparison.

The leading individual charge concerned listing or required information

Source: FDA Import Refusals Dashboard analysis. Establishments are counted by distinct FDA Establishment Identifier, or FEI. Charges overlap; the rows must not be added.

The leading individual charge, “NOT LISTED,” includes an apparent absence of required listing, notification or other information. It is broader than a finding that a particular device lacks approval.

“FRNMFGREG” concerns apparent manufacture or processing at an establishment that was not duly registered.

“NO PMA” concerns an apparent absence of applicable premarket approval or exemption. Its statutory wording should not be interpreted as a finding of physical contamination.

Analyst-grouped charges

Some FDA charge codes describe a similar underlying issue but include different administrative wording. The grouped analysis below combines the specified codes, counting each refused import line and each listed establishment only once within each group.

These are analyst-defined groups, not additional FDA charges.

Source: FDA Import Refusals Dashboard analysis and FDA’s charge-code dictionary.

The grouped listing/notification total is a deduplicated union. It must not be added to the individual “NOT LISTED” total. Likewise, the groups overlap with one another.

Codes containing administrative-destruction wording do not establish that physical destruction occurred. The grouping also keeps foreign-manufacturer registration separate from initial-distributor registration.

Does the dashboard increase persist without its largest contributor?

Yes, on the observed establishment dimension.

Source: FDA Import Refusals Dashboard, retrieved October 27, 2026. “Largest listed establishment” refers to the establishment with the largest FY2026 total, which was also the largest contributor to the dashboard increase. Each exclusion uses the same identities in both years.

These tests show that the dashboard increase persisted after those establishments’ recorded refused import lines were excluded. They do not establish the concentration of the historical 476-versus-190 comparison.

An FEI identifies an establishment and is not necessarily a corporate group. Shipper identities were not available, so shipper concentration remains unverified. No establishment is named or assessed for overall safety performance.

Why the legacy and dashboard totals differ

Source: FDA Import Refusals Dashboard and FDA legacy files. The legacy FY2026 figures use records dated through September 24, 2026.

In FY2026, 351 refused import lines appear in both sources. The legacy file contains 125 additional refused import lines with literal “XXX-” entry identifiers. The dashboard contains 14 additional refused import lines dated September 25 or September 28, after the latest date in the legacy extract.

The records can therefore be reconciled without treating the sources as interchangeable. The meaning of literal “XXX-” identifiers and the reason for their different treatment remain unresolved.

The sources are not added together, and the dashboard total is not used to calculate the historical record.

What practices can verify before buying

The purchasing questions below are a documentation workflow, not a physical-authentication procedure.

FDA provides public resources for checking approval, labeling, registration and listing. Distributor confirmation and keeping linked purchasing records are practical documentation recommendations; this study does not establish a new legal requirement.

Questions patients can ask before booking

• What is the exact name of the filler proposed?
• Can I read its patient labeling and discuss the intended use?
• How does the practice verify and document its U.S. source?
• Does the practice retain the relevant lot and purchasing records?

FDA advises patients to work with an appropriately licensed and experienced health professional and to review the labeling for the proposed filler. Asking about sourcing documentation complements that discussion; it does not independently authenticate a physical item.

Expert commentary

Dr. Hardik Soni, MD, MBA, co-founder and CTO of Face Med Store

“Before ordering a filler, a practice should check the exact product’s FDA premarket approval, or PMA, and its labeling, then check establishment registration and device listing separately. Confirm that the U.S. distributor is authorized by the manufacturer, and keep the lot details and invoice together. Registration is not product approval, and a database match does not authenticate the physical unit.”

Disclosure: The spokesperson’s company is a medical aesthetics supplier and does not sell dermal fillers. The quote was approved by the client on October 29, 2026.

Geographic scope

This is a national analysis of FDA import-refusal records.

The available country fields describe an establishment’s address, not verified product origin. The retrieved data do not establish U.S. destinations. There is therefore no country-of-origin ranking, state ranking or New York finding.

Methodology

Historical source files and inclusion rule

The historical series combines these FDA Import Refusal Report archives:

• Import_Refusal_2014-2018.zip
• Import_Refusal_2019-2023.zip
• Import_Refusal_2024-present.zip

The files were independently downloaded and reproduced on October 27, 2026. The inclusion rule is exact PRODUCT_CODE = 79LMH. There is no charge, establishment or country filter.

Counting and fiscal years

A refused import line is a distinct combination of:

ENTRY_NUM + RFRNC_DOC_ID + LINE_NUM + LINE_SFX_ID

Each combination is counted once across the combined archive records.

Fiscal years begin in October and end in September, labeled by the ending year. The historical comparison covers FY2015–FY2026. FY2014 is excluded because the available archive begins on January 2, 2014, during that fiscal year. The FY2026 extract contains records dated through September 24, 2026.

Primary and sensitivity rules

The primary series retains all qualifying refused import lines.

The sensitivity series excludes records where the entry identifier begins with literal XXX-. It does not infer why that prefix was assigned or identify those records as a particular distribution channel.

For each series, the previous peak is the largest annual count before FY2026 within the stated comparison period. Ratios divide the FY2026 total by that previous peak and are rounded to two decimal places.

Separate dashboard method

The dashboard analysis applies exact product code 79LMH and separate FY2025 and FY2026 filters, with no additional geographic or charge filter. All displayed records were captured from the public data table, and distinct identifiers were checked against the dashboard totals. This was not an API retrieval.

Charge tokens are mapped to FDA’s numeric ASC_ID dictionary. Repeated instances of the same charge on a refused import line are counted once. Grouped charges use the published codebook above and deduplicated unions. Establishment totals use distinct FEIs associated with at least one qualifying refused import line.

The concentration checks remove the same establishment identities from both fiscal years. Both alternatives are retained where the next-largest growth contribution is tied.

Limitations

• Available-record coverage: The finding is a record within the stated public series, not a claim about all historical FDA activity. FY2026 includes records dated through September 24, 2026.
• Incomplete final-year extract: The fiscal year had ended by retrieval, but the legacy file does not demonstrate complete coverage through the fiscal-year end.
• Source differences: Legacy and dashboard totals differ. The older overlapping years have not been reconciled against the dashboard line by line. FDA’s dashboard begins with records dated October 1, 2016.
• Changes in import review: ImportShield and SERIO+ changed the review process during the comparison period. Their contribution to the recorded totals cannot be isolated.
• No market denominator: The study does not calculate a refusal rate against all imported fillers or measure counterfeit prevalence.
• Unresolved distribution concentration: Shipper identities and physical distribution relationships were unavailable. Dashboard establishment tests do not resolve concentration across the historical legacy series.
• Geography: Establishment-address country is not product origin, and no destination ranking is supported.
• Charge interpretation: Charges can overlap. Cross-domain charge anomalies were retained and flagged rather than silently reclassified. A recorded charge does not establish a general judgment about an establishment.

Caveat for journalists

“These counts cover refused import lines for FDA product code 79LMH and do not measure counterfeit prevalence. The historical comparison uses FDA’s legacy files, whose coverage differs from its dashboard; FY2026 includes records dated through September 24, 2026. ImportShield and SERIO+ changed import review during the comparison period, and their contribution cannot be isolated. Shipper concentration remains unverified.”

Sources

Historical findings

Historical series, independently reproduced October 27, 2026.

Source files:

• FDA Import Refusal Report, 2014–2018
• FDA Import Refusal Report, 2019–2023
• FDA Import Refusal Report, 2024–present

Separate dashboard analysis

All entries below concern exact product code 79LMH in the FDA Import Refusals Dashboard, retrieved October 27, 2026.

• Annual dashboard counts and cohort denominators; FY2025 returned 151 refused import lines and FY2026 returned 365.
• Listed-establishment concentration and same-identity exclusion calculations.
• Individual charge counts and distinct-establishment counts.
• Analyst-grouped charge counts and codebook.
• Dashboard-to-legacy reconciliation.
• Charge-quality flags and missing-field limitations.

FDA definitions and practical resources

• FDA-CHARGES: ACT_SECTION_CHARGES.csv inside the FDA legacy download. This contains the full official charge wording.
• FDA-FIELDS: Import Refusals field definitions.
• FDA-LMH: LMH product classification.
• FDA-DASHBOARD: Import Refusals Dashboard and coverage caveats.
• FDA-REVIEW: Entry Review, including ImportShield and SERIO+.
• FDA-PMA: Premarket Approval database.
• FDA-FILLERS: FDA-approved dermal fillers and labeling resources.
• FDA-REGISTRATION: Establishment Registration & Device Listing.
• FDA-PATIENTS: Dermal Filler Do’s and Don’ts.

Update policy

This version uses the stated retrieval date and source snapshots. A later refresh should preserve the earlier table, identify any revised records, and publish a dated explanation of changes. The primary legacy series and the separate dashboard analysis should remain distinguishable in every update.