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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Topical Products

Pharma-Natural Inc.: Various Pain Relief and Cold Medications Recalled for Manufacturing Defects

Agency Publication Date: July 23, 2019
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Summary

Pharma-Natural Inc. is recalling approximately 59,878 units of various over-the-counter medications, including topical pain relief creams (such as Oliver's Harvest, AbeeMed, and LidoAID) and liquid cold medicines (such as Tusslin and Gencontuss). These products were manufactured without proper process validation, cleaning verification, or stability studies, which means the company cannot guarantee the drugs' safety, strength, or purity. While no specific injuries have been reported, using medications that do not meet manufacturing standards could lead to ineffective treatment or exposure to unexpected contaminants.

Risk

The lack of manufacturing controls and cleaning validation creates a risk that the products could be contaminated or contain incorrect amounts of active ingredients. This could result in patients receiving too little or too much medication, or potentially harmful substances being introduced during the manufacturing process.

What You Should Do

  1. Check your medicine cabinet for the following affected products: Oliver's Harvest (CBD+Capsaicin or CBD+Lidocaine), AbeeMed cream, ARMY HEALTH (Roll-On or Gel), GENCONTUSS, DOUBLE TUSSIN DM, LidoAID, Dermanak original, Lido E.R., Lid O Creme, Dayma SUPER FORTE XL10, TUSSLIN, SORBUGEN NR, NEOGEN-D, and Workvie Instant Pain Relieving Roll On.
  2. Verify the NDC and UPC codes on the packaging. For example, check for AbeeMed cream (UPC 8 50993 00402 4), GENCONTUSS (NDC 52083-650-16), and Workvie Roll On (NDC 72393-201-25).
  3. Immediately stop using any of these recalled products, especially if they are currently within their expiration dates.
  4. Contact your healthcare provider or pharmacist for guidance regarding alternative treatments and to discuss any health concerns you may have after using these products.
  5. Return any unused product to the pharmacy or place of purchase for a refund and contact Pharma-Natural Inc. at their corporate location in Miami Lakes, Florida, for further instructions.
  6. For additional questions or to report a problem, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

๐Ÿ’ฐFull Refund

Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

How to: Contact your healthcare provider or pharmacist for guidance. Return any unused product to the pharmacy for a refund

Affected Products

Product: Oliver's Harvest CBD+Capsaicin 0.2% Pain Relief Topical Analgesic Cream (4 OZ / 113.4 g)
Model:
NDC 63788-120-04
Recall #: D-1492-2019
Date Ranges: All lots remaining within expiry
Product: AbeeMed cream (2 OZ)
Model:
Recall #: D-1493-2019
UPC Codes:
850993004024
Date Ranges: All lots remaining within expiry
Product: ARMY HEALTH With CURCUMIN Pain Reliever Roll-On (2.5 FL OZ / 73ML)
Model:
Recall #: D-1494-2019
UPC Codes:
850993004086
Date Ranges: All lots remaining within expiry
Product: Oliver's Harvest CBD+Lidocaine HCL 4% Pain Relief Topical Analgesic Cream (4 OZ / 113.4 g)
Model:
NDC 63766-119-04
Recall #: D-1495-2019
Date Ranges: All lots remaining within expiry
Product: ARMY HEALTH Pain Reliever Gel With CURCUMIN (0.5 OZ)
Model:
Recall #: D-1496-2019
UPC Codes:
850993004611
Date Ranges: All lots remaining within expiry
Product: GENCONTUSS (Cherry Flavor, 16 fl oz / 474 mL)
Model:
NDC 52083-650-16
Recall #: D-1497-2019
Date Ranges: All lots remaining within expiry
Product: DOUBLE TUSSIN DM (4 FL OZ / 120 mL)
Model:
NDC 63708-121-04
Recall #: D-1498-2019
Date Ranges: All lots remaining within expiry
Product: LidoAID (Lidocaine HCL 4%) portable pain relieving TOPICAL ANALGESIC GEL (0.17 Oz / 4 g)
Model:
NDC 63788-114-04
Recall #: D-1499-2019
Date Ranges: All lots remaining within expiry
Product: Dermanak original crema blanqueador Skin Fade Cream (2 OZ / 56.7 g)
Model:
NDC 63788-108-02
Recall #: D-1500-2019
Date Ranges: All lots remaining within expiry
Product: Lido E.R. (Lidocaine HCL 4%) Pain Relieving Topical Analgesic Cream (4 oz / 113 g)
Model:
NDC 63788-115-04
Recall #: D-1501-2019
Date Ranges: All lots remaining within expiry
Product: Lid O Creme (Lidocaine HCL 4% and Menthol 1%) Topical Analgesic Cream (2.5 Oz / 71 g)
Model:
NDC 63788-111-25
Recall #: D-1502-2019
Date Ranges: All lots remaining within expiry
Product: Dayma SUPER FORTE XL10 Pain Relieving Topical Analgesic Gel (4 Oz / 113.4 g)
Model:
NDC 63788-118-04
Recall #: D-1503-2019
Date Ranges: All lots remaining within expiry
Product: TUSSLIN (Grape Flavor, 16 Fl.oz. / 474 mL)
Model:
NDC 52083-622-16
Recall #: D-1504-2019
Date Ranges: All lots remaining within expiry
Product: SORBUGEN NR (GRAPE FLAVOR, 16 Fl.oz. / 473 mL)
Model:
NDC 52083-660-16
Recall #: D-1505-2019
Date Ranges: All lots remaining within expiry
Product: NEOGEN-D (Raspberry Flavor, 16 fl oz / 473 mL)
Model:
NDC 52083-699-16
Recall #: D-1506-2019
Date Ranges: All lots remaining within expiry
Product: Workvie Instant Pain Relieving Roll On (2.5oz / 71 g)
Model:
NDC 72393-201-25
Recall #: D-1507-2019
Date Ranges: All lots remaining within expiry

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 83190
Status: Resolved
Manufacturer: Pharma-Natural Inc.
Sold By: Coast to Coast Natural, Inc.; Cas; Crossover Telecom, LLC.; Kramer Novis; Pamby Dist.; Diabetic Supply of Suncoast, Inc.; dba Advocate Diabetes; Biosfera International Distribution, LLC.; Marketite, LLC.
Manufactured In: United States
Units Affected: 16 products (998 bottles; 19422 jars; 4981 roll on bottles; 1000 bottles; 1508 jars; 3000 bottles; 500 bottles; 2000 roll on bottles; 1032 jars; 1070 jars; 310 roll on bottles; 1000 jars; 8340 bottles; 7392 bottles; 2052 bottles; 5273 roll on bottles)
Distributed To: Nationwide
Agency Last Updated: July 31, 2019

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.