Medications & Supplements/Topical Products

Eosera, Inc.: Ear Pain and Itch Relief Drops Recalled for Manufacturing Process Deviations

Agency Publication Date: August 13, 2020

Summary

Approximately 230,200 bottles of Eosera ear care products, including Ear Pain MD, Ear Pain MD For Kids, and Ear Itch MD, are being recalled due to deviations from Current Good Manufacturing Practice (cGMP) regulations. These deviations mean the products were not manufactured under the required quality control standards to ensure their safety and consistency. Consumers who have purchased these lidocaine or pramoxine-based drops and sprays should check their packaging for specific lot numbers and expiration dates ranging from 2020 through late 2021. You should contact a healthcare provider or pharmacist for guidance regarding the use of these products.

Risk

Failure to follow Good Manufacturing Practice regulations can lead to products that do not meet quality specifications, potentially resulting in contamination or incorrect ingredient concentrations. While no specific injuries were reported, using medications produced under substandard conditions poses a risk of ineffective treatment or unexpected adverse reactions.

What You Should Do

Check your medicine cabinet for Ear Pain MD (0.5 FL OZ), Ear Pain MD For Kids (0.5 FL OZ), Ear Itch MD Anti-Itch Spray (0.5 FL OZ), or the Day & Night Pack including Nighttime Intensive Soothing Spray.
Verify your lot numbers for Ear Pain MD For Kids (NDC 72429-0070-8): P203093 (Exp DEC 21), P203026 (Exp JUN 21), P193084, P193044 (Exp APR 21), P193073, P193072, P193071, P193070 (Exp FEB 21), P192050 (Exp MAY 21), P193042 (Exp MAR 21), P193013 (Exp JAN 21), or P193012 (Exp DEC 20).
Verify your lot numbers for Ear Pain MD (NDC 72429-0072-2): P203076, P203075 (Exp NOV 21); P203061, P203057 (Exp AUG 21); P203047, P203044, P203040 (Exp JUL 21); P203033, P203030, P203016, P203015, P203002, P203001, P193053 (Exp JUN 21); P203024, P193097 (Exp MAY 21); P203017 (Exp JUL 20); P193091, P193089, P193088, P193087 (Exp APR 21); P193068, P193067 (Exp FEB 21); P193064, P193063, P193062, P193059, P193014 (Exp JAN 21); P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001 (Exp DEC 20); or P183018, P183017 (Exp SEP 20).
Verify your lot numbers for Ear Itch MD (NDC 72429-0071-5, UPC 851722007125): F203071 (Exp SEP 21), F203059 (Exp OCT 21), F193095, F193094 (Exp MAY 21), F193093 (Exp APR 21), F193082 (Exp MAR 21), F193069 (Exp FEB 21), F193061 (Exp JAN 21), F193058, F193054 (Exp DEC 20), or F193032 through F193024 (Exp AUG 20).
Verify your lot numbers for Day & Night Pack Ear Itch MD (NDC 72429-0071-5): TP203073 (Exp SEP 21), TP203055 (Exp OCT 21), TP203012, TP203009, or TP203006 (Exp JUN 21).
Contact your healthcare provider or pharmacist for guidance regarding these products and return any unused portions to the pharmacy or place of purchase for a refund.
Contact Eosera, Inc. directly for further instructions at their Fort Worth, Texas location at 5000 South Fwy Ste 106, Fort Worth, Texas, 76115-3902.
For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Your Remedy Options

Full Refund

Healthcare provider consultation and pharmacy refund

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

Affected Products

Product: Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0070-8

Lot Numbers:

P203093 (Exp. DEC 21)

P203026 (Exp. JUN 21)

P193084 (Exp. APR 21)

P193044 (Exp. APR 21)

P193073 (Exp. FEB 21)

P193072 (Exp. FEB 21)

P193071 (Exp. FEB 21)

P193070 (Exp. FEB 21)

P192050 (Exp. MAY 21)

P193042 (Exp. MAR 21)

P193013 (Exp. JAN 21)

P193012 (Exp. DEC 20)

Date Ranges: December 2020 - December 2021

Product: Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0072-2

Lot Numbers:

P203076 (Exp. NOV 21)

P203075 (Exp. NOV 21)

P203061 (Exp. AUG 21)

P203057 (Exp. AUG 21)

P203047 (Exp. JUL 21)

P203044 (Exp. JUL 21)

P203040 (Exp. JUL 21)

P203033 (Exp. JUN 21)

P203030 (Exp. JUN 21)

P203016 (Exp. JUN 21)

P203015 (Exp. JUN 21)

P203002 (Exp. JUN 21)

P203001 (Exp. JUN 21)

P193053 (Exp. JUN 21)

P203024 (Exp. MAY 21)

P193097 (Exp. MAY 21)

P203017 (Exp. JUL 20)

P193091 (Exp. APR 21)

P193089 (Exp. APR 21)

P193088 (Exp. APR 21)

P193087 (Exp. APR 21)

P193068 (Exp. FEB 21)

P193067 (Exp. FEB 21)

P193064 (Exp. JAN 21)

P193063 (Exp. JAN 21)

P193062 (Exp. JAN 21)

P193059 (Exp. JAN 21)

P193014 (Exp. JAN 21)

P193057 (Exp. DEC 20)

P193056 (Exp. DEC 20)

P193055 (Exp. DEC 20)

P193011 (Exp. DEC 20)

P193010 (Exp. DEC 20)

P193009 (Exp. DEC 20)

P193008 (Exp. DEC 20)

P193007 (Exp. DEC 20)

P193006 (Exp. DEC 20)

P192005 (Exp. DEC 20)

P193003 (Exp. DEC 20)

P193002 (Exp. DEC 20)

P193001 (Exp. DEC 20)

P183018 (Exp. SEP 20)

P183017 (Exp. SEP 20)

Date Ranges: September 2020 - November 2021

Product: Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0071-5

UPC Codes:

851722007125

Lot Numbers:

F203071 (Exp. SEP 21)

F203059 (Exp. OCT 21)

F193095 (Exp. MAY 21)

F193094 (Exp. MAY 21)

F193093 (Exp. APR 21)

F193082 (Exp. MAR 21)

F193069 (Exp. FEB 21)

F193061 (Exp. JAN 21)

F193058 (Exp. DEC 20)

F193054 (Exp. DEC 20)

F193032 (Exp. AUG 20)

F193030 (Exp. AUG 20)

F193029 (Exp. AUG 20)

F193028 (Exp. AUG 20)

F193027 (Exp. AUG 20)

F193026 (Exp. AUG 20)

F193025 (Exp. AUG 20)

F193024 (Exp. AUG 20)

Date Ranges: August 2020 - October 2021

Product: Day & Night Pack Ear Itch MD Anti-Itch Spray / Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0071-5

Lot Numbers:

TP203073 (Exp. SEP 21)

TP203055 (Exp. OCT 21)

TP203012 (Exp. JUN 21)

TP203009 (Exp. JUN 21)

TP203006 (Exp. JUN 21)

Date Ranges: June 2021 - October 2021

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 86171

Status: Resolved

Manufacturer: Eosera, Inc.

Sold By: authorized retailers; specialty retailers

Manufactured In: United States

Units Affected: 4 products (45,673 bottles; 125,874 bottles; 43,424 bottles; 15229 bottles)

Distributed To: Nationwide

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 · 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.

Summary

Risk

What You Should Do

Check your medicine cabinet for Ear Pain MD (0.5 FL OZ), Ear Pain MD For Kids (0.5 FL OZ), Ear Itch MD Anti-Itch Spray (0.5 FL OZ), or the Day & Night Pack including Nighttime Intensive Soothing Spray.

Verify your lot numbers for Ear Pain MD For Kids (NDC 72429-0070-8): P203093 (Exp DEC 21), P203026 (Exp JUN 21), P193084, P193044 (Exp APR 21), P193073, P193072, P193071, P193070 (Exp FEB 21), P192050 (Exp MAY 21), P193042 (Exp MAR 21), P193013 (Exp JAN 21), or P193012 (Exp DEC 20).

Verify your lot numbers for Ear Pain MD (NDC 72429-0072-2): P203076, P203075 (Exp NOV 21); P203061, P203057 (Exp AUG 21); P203047, P203044, P203040 (Exp JUL 21); P203033, P203030, P203016, P203015, P203002, P203001, P193053 (Exp JUN 21); P203024, P193097 (Exp MAY 21); P203017 (Exp JUL 20); P193091, P193089, P193088, P193087 (Exp APR 21); P193068, P193067 (Exp FEB 21); P193064, P193063, P193062, P193059, P193014 (Exp JAN 21); P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001 (Exp DEC 20); or P183018, P183017 (Exp SEP 20).

Verify your lot numbers for Ear Itch MD (NDC 72429-0071-5, UPC 851722007125): F203071 (Exp SEP 21), F203059 (Exp OCT 21), F193095, F193094 (Exp MAY 21), F193093 (Exp APR 21), F193082 (Exp MAR 21), F193069 (Exp FEB 21), F193061 (Exp JAN 21), F193058, F193054 (Exp DEC 20), or F193032 through F193024 (Exp AUG 20).

Verify your lot numbers for Day & Night Pack Ear Itch MD (NDC 72429-0071-5): TP203073 (Exp SEP 21), TP203055 (Exp OCT 21), TP203012, TP203009, or TP203006 (Exp JUN 21).

Contact your healthcare provider or pharmacist for guidance regarding these products and return any unused portions to the pharmacy or place of purchase for a refund.

Contact Eosera, Inc. directly for further instructions at their Fort Worth, Texas location at 5000 South Fwy Ste 106, Fort Worth, Texas, 76115-3902.

For additional questions, contact the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls.

Affected Products

Product: Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0070-8

Lot Numbers:

P203093 (Exp. DEC 21)

P203026 (Exp. JUN 21)

P193084 (Exp. APR 21)

P193044 (Exp. APR 21)

P193073 (Exp. FEB 21)

P193072 (Exp. FEB 21)

P193071 (Exp. FEB 21)

P193070 (Exp. FEB 21)

P192050 (Exp. MAY 21)

P193042 (Exp. MAR 21)

P193013 (Exp. JAN 21)

P193012 (Exp. DEC 20)

Date Ranges: December 2020 - December 2021

Product: Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0072-2

Lot Numbers:

P203076 (Exp. NOV 21)

P203075 (Exp. NOV 21)

P203061 (Exp. AUG 21)

P203057 (Exp. AUG 21)

P203047 (Exp. JUL 21)

P203044 (Exp. JUL 21)

P203040 (Exp. JUL 21)

P203033 (Exp. JUN 21)

P203030 (Exp. JUN 21)

P203016 (Exp. JUN 21)

P203015 (Exp. JUN 21)

P203002 (Exp. JUN 21)

P203001 (Exp. JUN 21)

P193053 (Exp. JUN 21)

P203024 (Exp. MAY 21)

P193097 (Exp. MAY 21)

P203017 (Exp. JUL 20)

P193091 (Exp. APR 21)

P193089 (Exp. APR 21)

P193088 (Exp. APR 21)

P193087 (Exp. APR 21)

P193068 (Exp. FEB 21)

P193067 (Exp. FEB 21)

P193064 (Exp. JAN 21)

P193063 (Exp. JAN 21)

P193062 (Exp. JAN 21)

P193059 (Exp. JAN 21)

P193014 (Exp. JAN 21)

P193057 (Exp. DEC 20)

P193056 (Exp. DEC 20)

P193055 (Exp. DEC 20)

P193011 (Exp. DEC 20)

P193010 (Exp. DEC 20)

P193009 (Exp. DEC 20)

P193008 (Exp. DEC 20)

P193007 (Exp. DEC 20)

P193006 (Exp. DEC 20)

P192005 (Exp. DEC 20)

P193003 (Exp. DEC 20)

P193002 (Exp. DEC 20)

P193001 (Exp. DEC 20)

P183018 (Exp. SEP 20)

P183017 (Exp. SEP 20)

Date Ranges: September 2020 - November 2021

Product: Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0071-5

UPC Codes:

851722007125

Lot Numbers:

F203071 (Exp. SEP 21)

F203059 (Exp. OCT 21)

F193095 (Exp. MAY 21)

F193094 (Exp. MAY 21)

F193093 (Exp. APR 21)

F193082 (Exp. MAR 21)

F193069 (Exp. FEB 21)

F193061 (Exp. JAN 21)

F193058 (Exp. DEC 20)

F193054 (Exp. DEC 20)

F193032 (Exp. AUG 20)

F193030 (Exp. AUG 20)

F193029 (Exp. AUG 20)

F193028 (Exp. AUG 20)

F193027 (Exp. AUG 20)

F193026 (Exp. AUG 20)

F193025 (Exp. AUG 20)

F193024 (Exp. AUG 20)

Date Ranges: August 2020 - October 2021

Product: Day & Night Pack Ear Itch MD Anti-Itch Spray / Ear Itch MD Nighttime Intensive Soothing Spray (pramoxine HCL 1%) 0.5 FL OZ (15 mL)

Model:

NDC 72429-0071-5

Lot Numbers:

TP203073 (Exp. SEP 21)

TP203055 (Exp. OCT 21)

TP203012 (Exp. JUN 21)

TP203009 (Exp. JUN 21)

TP203006 (Exp. JUN 21)

Date Ranges: June 2021 - October 2021