Pharma-Natural Inc.

FDA Regulatory Profile

Pharma-Natural Inc. has 17 FDA recalls, 3 inspections, 0 510(k) clearances and 0 compliance actions on record.

Latest recall
F-1615-2023 · Class III · Aug 15, 2023
Latest inspection
Jun 23, 2023 · VAI

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Summary

Record counts and when each FDA source was last refreshed
RecordsCountLast refreshedSource as ofStatus
Recalls17Nov 4, 2026 (checked Nov 8, 2026, unchanged)File dated Nov 3, 2026Current
510(k) clearances0Nov 8, 2026File dated Nov 2, 2026Current
Inspections3Nov 9, 2026Newest record Oct 28, 2026Current
Compliance actions0Nov 2, 2026Newest record Oct 29, 2026Current

Recent Recalls

NumberClassProductDate
F-1615-2023Class IIIPharma Natural, Biotin 5000 mcg, Maximum Strength, Dietary Supplement, 30 TabletsAug 15, 2023
D-1502-2019Class IILid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle…Jun 21, 2019
D-1498-2019Class IIDOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120…Jun 21, 2019
D-1494-2019Class IIARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle…Jun 21, 2019
D-1503-2019Class IIDayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical…Jun 21, 2019
D-1507-2019Class IIWorkvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll…Jun 21, 2019
D-1501-2019Class IILido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed…Jun 21, 2019
D-1492-2019Class IIOliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ…Jun 21, 2019
D-1499-2019Class IILidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on…Jun 21, 2019
D-1496-2019Class IIARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively…Jun 21, 2019
D-1506-2019Class IINEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL…Jun 21, 2019
D-1493-2019Class IIAbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas…Jun 21, 2019
D-1495-2019Class IIOliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ…Jun 21, 2019
D-1504-2019Class IITUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL…Jun 21, 2019
D-1505-2019Class IISORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL…Jun 21, 2019
D-1497-2019Class IIGENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in…Jun 21, 2019
D-1500-2019Class IIDermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar…Jun 21, 2019

Recent FDA Inspections

DateSiteProductClassificationFEI
Jun 23, 2023Miami Lakes, FLFood/CosmeticsVoluntary Action Indicated (VAI)3010636005
Mar 29, 2019Miami Lakes, FLDrugsOfficial Action Indicated (OAI)3010636005
Aug 17, 2016Miami Lakes, FLFood/CosmeticsVoluntary Action Indicated (VAI)3010636005

NAI means no objectionable conditions or practices were found during the inspection. VAI means objectionable conditions or practices were found, but the agency is not prepared to take or recommend any administrative or regulatory action. OAI means regulatory and/or administrative actions are recommended.

FDA-Inspected Facilities

FacilityLocationInspectionsLatest
FEI 3010636005Miami Lakes, FL3Jun 23, 2023

Sources: openFDA, FDA Data Dashboard, FDA.gov. Report a data issue: hello@regdatalab.com.