TERPENICOL Antifungal Cream (Undecylenic Acid 13%) recall — Blaine Labs Inc (Class II)

Blaine Labs Inc is recorded by the U.S. Food and Drug Administration (FDA) as recalling TERPENICOL Antifungal Cream (Undecylenic Acid 13%) — a Class II recall, initiated 2026-04-08 and posted to the FDA enforcement report on 2026-07-08, under recall number D-0695-2026. Status Ongoing, with no termination date on the record. The reason the FDA record carries is, verbatim: “CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry”. From the product description, the form is cream and the strengths given are 13%, 28 g and 11037 L. 1 National Drug Code number is printed in the record: 63347-601-01. Distribution is recorded as “Nationwide in the USA” — Nationwide (US), with the recalling firm on record in CA, United States. The FDA files it under event ID 98731 together with 7 other recall numbers, all listed and linked below. Within that event this is the strength 13% · 28 g · 11037 L, form Cream and ndc 63347-601-01 configuration; the sibling records differ on strength, package, form and ndc, and 3 more and match on everything else the source states. Values are reproduced from the linked openFDA report; regulatory information, not medical advice.

Regulatory snapshot

Recall number	D-0695-2026
FDA event ID	98731 (8 recall numbers)
Classification	Class II (intermediate regulatory tier)
Status	Ongoing
Recalling firm	Blaine Labs Inc
Recall initiated	2026-04-08
Reported by FDA	2026-07-08
Report lag	91 days from initiation to report
Distribution	Nationwide in the USA — Nationwide (US)
Firm location on record	CA, United States
Product description (source)	TERPENICOL Antifungal Cream (Undecylenic Acid 13%), 1.0 oz (28 g) bottles, Manufactured By: Blaine Labs, Inc., 11037 Lockport Place, Sante Fe Springs, CA 90670, NDC 63347-601-01.

Reason reported by FDA

CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry

16 words from the enforcement report field reason_for_recall, reproduced without edit — the firm's own wording, not an assessment.

Product identifiers in this record

6 identifying values matched by exact pattern in the 26-word product description above; each is a literal substring of it.

Product named	TERPENICOL Antifungal Cream (Undecylenic Acid 13%)
Form	Cream
Strength	13% · 28 g · 11037 L
NDC	63347-601-01
Manufactured by	Blaine Labs, Inc.

Which configuration this record is

8 recall numbers share event 98731. They differ on strength, package, form, ndc, product named, fda tier and reason text and agree on everything else the source states, so those are the values to check a package against.

Attribute	This record (D-0695-2026)	D-0692-2026	D-0693-2026	D-0694-2026	D-0696-2026	D-0697-2026	D-0698-2026	D-0699-2026
Strength	13% · 28 g · 11037 L	0.1% · 37 mL · 11037 L	0.1% · 29.6 mL	25% · 37.5 mL	10% · 15 g · 11037 L	25% · 29.6 mL · 11037 L	25% · 11037 L	0.1% · 16 mL · 85 g · 11037 L
Package	—	1.0 FL OZ (37 mL)	1.0 fl oz	1.25 FL OZ (37.5 mL)	—	1.0 Fl Oz (29.6 mL)	—	1.0 Fl OZ (16 mL) · 3.0 Fl OZ (85 g)
Form	Cream	Gel	Gel	Solution	Cream	Solution	Solution	Gel
NDC	63347-601-01	63347-120-02	73352-520-01	73352-550-01	—	63347-600-01	—	63347-120-02 · 63347-120-01
Product named	TERPENICOL Antifungal Cream (Undecylenic Acid 13%)	Revitaderm Wound Care Gel	TRIFLUENT PHARMA TRIDERGEL Wound Care Gel	TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)	vite20 Antifungal Cream	TERPENICOL Antifungal Solution	Fungal Fusion ERADICATION Solution	Revitaderm Wound Care
FDA tier	Class II	Class I	Class II	Class II	Class II	Class II	Class II	Class II
Reason text	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	Microbial contamination of Non-Sterile Product: samples identified the presence of Lysinibacillus fusiformis and other Bacillus spp	CGMP Deviations: product manufactured in the same facility under the same conditions as the product found to be contaminated	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	CGMP Deviations; the firm discontinued required stability testing for products on the market still within expiry	CGMP Deviations; product manufactured in the same facility under the same conditions as the product found to be contaminated

Shared across all 8 records under this event: recalling firm Blaine Labs Inc; initiated 2026-04-08; reported 2026-07-08.

Event context: 8 recall numbers under event 98731

One enforcement action, 8 recall numbers: the FDA filed 7 further configurations of this action under event 98731. Each keeps its own recall number and dates.

Recall record	Recall number	FDA tier	Strength / form	NDC	Reported
Revitaderm Wound Care Gel, 0.1%	D-0692-2026	Class I	0.1% · Gel	63347-120-02	2026-07-08
TRIFLUENT PHARMA TRIDERGEL Wound Care Gel, 0.1%	D-0693-2026	Class II	0.1% · Gel	73352-520-01	2026-07-08
TRIPENICOL S Antifungal Solution (Undecylenic Acid 25%)	D-0694-2026	Class II	25% · Solution	73352-550-01	2026-07-08
vite20 Antifungal Cream, 10%	D-0696-2026	Class II	10% · Cream	—	2026-07-08
TERPENICOL Antifungal Solution, 25%	D-0697-2026	Class II	25% · Solution	63347-600-01	2026-07-08
Fungal Fusion ERADICATION Solution, 25%	D-0698-2026	Class II	25% · Solution	—	2026-07-08
Revitaderm Wound Care, 0.1%	D-0699-2026	Class II	0.1% · Gel	63347-120-02	2026-07-08

Reported in the same month (2026-07)

111 enforcement reports carry a report date in 2026-07; these 8 are the Class II ones nearest this record.

Recall record	Recall number	Recalling firm	FDA tier	Reported
BD ChloraPrep Hi-Lite Orange, 2%	D-0643-2026	Carefusion 213, LLC	Class II	2026-07-08
BD PurPrep, 8.3%	D-0644-2026	Carefusion 213, LLC	Class II	2026-07-08
BD ChloraPrep Clear, 2%	D-0645-2026	Carefusion 213, LLC	Class II	2026-07-08
ChloraPrep FREPP, 2%	D-0646-2026	Carefusion 213, LLC	Class II	2026-07-08
BD ChloraPrep Hi-Lite Orange, 2%	D-0647-2026	Carefusion 213, LLC	Class II	2026-07-08
BD ChloraPrep Hi-Lite Orange, 2%	D-0648-2026	Carefusion 213, LLC	Class II	2026-07-08
BD ChloraPrep Scrub Teal, 2%	D-0649-2026	Carefusion 213, LLC	Class II	2026-07-08
BD ChloraPrep Scrub Teal, 2%	D-0650-2026	Carefusion 213, LLC	Class II	2026-07-08

Nearest Class II recalls by date

213 of 250 indexed records share the Class II tier; the 1 nearest to 2026-07-08 by report date are listed here.

Recall record	Recall number	Recalling firm	Strength / form	Reported
BD ChloraPrep CLear, 2%	D-0651-2026	Carefusion 213, LLC	2% · Solution	2026-07-08

Reading this record

Class II is the FDA's own severity tier for the recall action — 213 of the 250 indexed records carry it — and it describes the agency's assessment of the action, not a risk statement about any individual. A search on event 98731 returns all 8 of these recall numbers; a search on D-0695-2026 returns only this configuration. Match a package against 63347-601-01 at the FDA source to confirm it is covered.

Namespace context: the Class II index (213 records) and the recall hub (250 records, 118 FDA events); Blaine Labs Inc (8 indexed records) aggregates this firm across datasets.

Coverage and limits of this record

This page reflects the openFDA enforcement report for D-0695-2026 as ingested on 2026-08-22, which can lag the live FDA record and omits detail held only in primary documents. It offers no clinical assessment, no advice about whether to use any product, and no substitute. For any health question consult a qualified healthcare professional.

Source & provenance

Official source: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0695-2026%22
Source dataset: openFDA Drug Enforcement API
Publication date: 2026-07-08
Ingested: 2026-08-22
Record hash: 05ae1e2464a440ab

Verify every value against the official FDA source above. This site links to the regulator's record rather than replacing it.