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Unrated Drug recall · FDA · Published June 21, 2019

Pharma-Natural GENCONTUSS recall: Manufacturing violations risk product safety

Pharma-Natural Inc. recalls GENCONTUSS cough syrup due to manufacturing process failures. Products may not be safe as they were made without proper quality checks. Consumers should check their bottles for the NDC number 52083-650-16.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-1497-2019DrugPharma-Natural ›
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Contact the company

Recalling firmPharma-Natural Inc.14500 Nw 60th Ave Bldg 7f · Miami Lakes, FL 33014
✎ GovInfoNow plain-language explainer

Pharma-Natural Inc. is recalling GENCONTUSS cough syrup because it was made without proper quality checks. This could mean the product is unsafe and might cause health problems if used. Read more at govinfonow.com/recall/38510-pharma-natural-gencontuss-recall-manufacturing-violations-risk-product-safety.

Source Summary by GovInfoNow · govinfonow.com/recall/38510-pharma-natural-gencontuss-recall-manufacturing-violations-risk-product-safety · Updated October 5, 2026 · FDA enforcement record: FDA #D-1497-2019

Cite this page

“Pharma-Natural GENCONTUSS recall: Manufacturing violations risk product safety.” GovInfoNow, updated October 5, 2026. https://govinfonow.com/recall/38510-pharma-natural-gencontuss-recall-manufacturing-violations-risk-product-safety. Based on FDA recall #D-1497-2019 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-1497-2019%22&limit=1).

The FDA announced on June 21, 2019, that Pharma-Natural Inc. voluntarily recalled GENCONTUSS due to current good manufacturing practice violations. The agency classified the recall as Class II.

How to tell if you have it

  • Brand: Pharma-Natural
  • Product: GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp
  • Flavor: Cherry Flavor
  • Size: 16 fl oz (474 mL) bottle
  • NDC: 52083-650-16
  • Quantity: 3000 bottles

The hazard

According to the FDA, the products were manufactured with a lack of process validation, cleaning validation, stability studies, and other current good manufacturing practice violations.

Context

GovInfoNow's records show Pharma-Natural Inc. has one other recall on record since August 15, 2023. Other recent recalls of similar products include Xiamen Kang Zhongyuan Biotechnology Cough Drops Recall (March 20, 2026), Wells Pharma Fentanyl Citrate Injectable Solution Recall (April 1, 2026), and QC Quality Choice Cough Drops Recall (March 20, 2026).

How to tell if you have this one

Check for the NDC number 52083-650-16 on the bottle label. The product is a 16 fl oz (474 mL) cherry-flavored cough syrup with the manufacturer's address in San Juan, PR.

  • Brand
    Pharma-Natural
  • Category
    Drug
FDA recall event · 16 products

All 16 products in this recall

FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.

  • Classification
    Class II
  • Status
    Terminated
  • Distribution
    Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.
Recall numberProduct, codes & lotsQuantityNDC
D-1492-2019Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief (Capsaicin 0.2%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63788-120-04.; All lots remaining within expiry.998 bottles—
D-1493-2019AbeeMed cream (Menthol 1.48% and Histamine DHCL 0.05%), 2 OZ jar, Manufactured exclusively for: Cas, P.O. Box 520248, Miami, FL 33152, UPC 8 50993 00402 4.; All lots remaining within expiry.19422 jars—
D-1494-2019ARMY HEALTH With CURCUMIN (Menthol 3.00%) Pain Reliever Roll-On, 2.5 FL OZ (73ML) roll on bottle, Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00408 6.; All lots remaining within expiry.4981 roll on bottles—
D-1495-2019Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief (Lidocaine HCL 4%) Topical Analgesic Cream, 4 OZ (113.4 g) bottle with pump, Distributed by: Coast to Coast Natural, Inc., Wellington, FL 33414, NDC 63766-119-04.; All lots remaining within expiry.1000 bottles—
D-1496-2019ARMY HEALTH Pain Reliever Gel With CURCUMIN (Menthol 3.00%), 0.5 OZ jar, Manufactured exclusively for: Manufactured exclusively for: Crossover Telecom, LLC., P.O. Box 520248, Miami, FL 33122, UPC 8 50993 00461 1.; All lots remaining within expiry.1508 jars—
D-1497-2019GENCONTUSS (Chlorpheniramine Maleate, 2mg; Dextromethorphan HBr, 10 mg; Phenylephrine HCl, 5 mg) in each 5 mL tsp, Cherry Flavor, 16 fl oz (474 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-650-16.; All lots remaining within expiry.3000 bottles52083-650-16
D-1498-2019DOUBLE TUSSIN DM (Dextromethorphan Hbr 20 mg, Guaifenesin 300 mg) in each 5ml teaspoon, 4 FL OZ (120 mL) bottle, Distributed by: Pamby Dist., Miami, FL 33414, NDC 63708-121-04.; All lots remaining within expiry.500 bottles—
D-1499-2019LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL, 0.17 Oz (4 g) roll on bottle, Distributed by: Diabetic Supply of Suncoast, Inc., dba Advocate Diabetes, PO Box 2102, Vega Alta, PR 00692, NDC 63788-114-04.; All lots remaining within expiry.2000 roll on bottles—
D-1500-2019Dermanak original crema blanqueador (Hydroquinone 2%) Skin Fade Cream, 2 OZ. (56.7 g) jar, Manufactured by: Pamby Distributors, Inc., Miami, FL 33126, NDC 63788-108-02.; All lots remaining within expiry.1032 jars—
D-1501-2019Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream, 4 oz (113 g) jar, Distributed by Diabetic Supply of Suncoast, Inc., P.O. Box 2102, Vega Alta, PR 00692, NDC 63788-115-04.; All lots remaining within expiry.1070 jars—
D-1502-2019Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream, 2.5 Oz (71 g) roll on bottle, Manufactured & Distributed by: Pharma Natural, Inc. Hialeah, FL 33016, NDC 63788-111-25.; All lots remaining within expiry.310 roll on bottles—
D-1503-2019Dayma SUPER FORTE XL10 (Camphor 0.5%, Menthol 2%, Methyl Salicylate 2%) Pain Relieving Topical Analgesic Gel, 4 Oz (113.4 g) jar, Distributed by: Biosfera International Distribution, LLC., Miami Lakes, FL 33016, NDC 63788-118-04.; All lots remaining within expiry.1000 jars—
D-1504-2019TUSSLIN (Dextromethorphan HBr, 28 mg; Guaifenesin, 388 mg; Phenylephrine HCl, 10 mg) in each 5 mL tsp, Grape Flavor, 16 Fl.oz. (474 mL) bottle, Kramer Novis, San Juan, PR 00917, NDC 52083-622-16.; All lots remaining within expiry.8340 bottles—
D-1505-2019SORBUGEN NR (Dextromethorphan HBr, 15 mg; Glyceryl Guaiacolate (Guaifenesin), 150 mg) in each 7.5 mL 1 1/2 tsp), GRAPE FLAVOR, 16 Fl.oz. (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-660-16.; All lots remaining within expiry.7392 bottles52083-660-16
D-1506-2019NEOGEN-D (Dextromethorphan HBr, 30 mg; Guaifenesin, 200 mg; Phenylephrine HCl, 7.5 mg) in each 5 mL tsp, Raspberry Flavor, 16 fl oz (473 mL) bottle, Manufactured in the USA for Kramer Novis, San Juan, PR 00917, NDC 52083-699-16.; All lots remaining within expiry.2052 bottles—
D-1507-2019Workvie Instant Pain Relieving Roll On (Lidocaine HCL 4% + Menthol 1% & Arnica), 2.5oz (71 g) roll on bottle, Exclusively Distributed by: Marketite, LLC., Coral Gables, FL 33134, NDC 72393-201-25.; All lots remaining within expiry.5273 roll on bottles—
Based on the official FDA remedy

What to do — step by step

  1. Check Product Label

    Look for the NDC number 52083-650-16 on the bottle to confirm it's the recalled product.

Where it went and when

Where it was distributed

Distributed nationwide; the notice names 2 states.

Alaska: nationwideAKMaine: nationwideMEVermont: nationwideVTNew Hampshire: nationwideNHWashington: nationwideWAIdaho: nationwideIDMontana: nationwideMTNorth Dakota: nationwideNDMinnesota: nationwideMNIllinois: nationwideILWisconsin: nationwideWIMichigan: nationwideMINew York: nationwideNYRhode Island: nationwideRIMassachusetts: nationwideMAOregon: nationwideORNevada: nationwideNVWyoming: nationwideWYSouth Dakota: nationwideSDIowa: nationwideIAIndiana: nationwideINOhio: nationwideOHPennsylvania: nationwidePANew Jersey: nationwideNJConnecticut: nationwideCTCalifornia: nationwideCAUtah: nationwideUTColorado: nationwideCONebraska: nationwideNEMissouri: nationwideMOKentucky: nationwideKYWest Virginia: nationwideWVVirginia: nationwideVAMaryland: nationwideMDDelaware: nationwideDEArizona: nationwideAZNew Mexico: nationwideNMKansas: nationwideKSArkansas: nationwideARTennessee: nationwideTNNorth Carolina: nationwideNCSouth Carolina: nationwideSCDistrict of Columbia: nationwideDCOklahoma: nationwideOKLouisiana: nationwideLAMississippi: nationwideMSAlabama: nationwideALGeorgia: nationwideGAHawaii: nationwideHITexas: named in the noticeTXFlorida: named in the noticeFLPuerto Rico: named in the noticePR

FDA distribution: “Consignees in FL and TX who may have further distributed Nationwide in the USA and Puerto Rico.” States read from FDA’s own wording; “not listed” means the notice does not name it.

Named in the notice: Florida, Puerto Rico, Texas.

Recall timeline

FDA terminated this recall 2.4 years after the firm started it.

1. Firm started the recall: Jun 21, 201912. FDA classified it Class II: Jul 23, 201923. Published in FDA’s Enforcement Report: Jul 31, 201934. FDA terminated the recall: Oct 27, 2021420192021
  1. Firm started the recall
  2. FDA classified it Class II
  3. Published in FDA’s Enforcement Report
  4. FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Keep exploring

Where this comes from

The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.

  • Official source: FDA Recall #D-1497-2019 (June 21, 2019) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-1497-2019 to see it in context.
  • Plain-language summary written by qwen3:4b on October 5, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
  • GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.
GovInfoNow is an independent guide. We are not FDA or any government agency. Always confirm details with the official recall.Data: CPSC · FDA · NHTSA · USDA