Milbar Laboratories, Inc.: Coal Tar and Zinc Pyrithione Shampoos Recalled for Being Subpotent

Agency Publication Date: May 22, 2018

Summary

Approximately 2,300 bottles of T Shampoo For Hair and Body (0.6% coal tar) and Zoma Shampoo (Zinc Pyrithione 1.92%) have been voluntarily recalled because they are subpotent, meaning they contain less of the active ingredient than required. Using subpotent medicated shampoos can result in the product being less effective at treating scalp conditions like dandruff, seborrheic dermatitis, or psoriasis. These products were sold through physicians and online sales across the United States and internationally, including Central America and several countries in the Middle East and Asia.

Risk

The affected shampoos contain lower-than-intended levels of active medications, which may fail to provide the therapeutic relief expected for the skin or scalp conditions they are intended to treat.

What You Should Do

Check your bottle of T Shampoo For Hair and Body (300 ml/10.1 fl. oz.) for lot number MT390-8 (expiration date 12/01/2020) or lot number GU925-4 (expiration date 07/05/2020).
Check your bottle of Zoma Shampoo (300 ml/10.01 fl. oz.) for lot number HT659-6 (expiration date 08/11/2019) or lot number LT168-7 (expiration date 11/10/2019).
If you have an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and the effectiveness of the medication.
Return any unused product to the pharmacy or place of purchase for a refund and contact Milbar Laboratories, Inc. at 20 Commerce St, East Haven, CT 06512 for further instructions.
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

Full Refund

Drug product refund and consultation

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

Affected Products

Product: T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar) (300 ml / 10.1 fl. oz.)

Model:

Recall #: D-0832-2018

Lot Numbers:

MT390-8 (Exp 12/01/2020)

GU925-4 (Exp 07/05/2020)

Date Ranges: 12/01/2020, 07/05/2020

Product: Zoma Shampoo, Zinc Pyrithione 1.92% (300 ml / 10.01 fl. oz.)

Model:

Recall #: D-0833-2018

Lot Numbers:

HT659-6 (Exp 08/11/2019)

LT168-7 (Exp 11/10/2019)

Date Ranges: 08/11/2019, 11/10/2019

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 80045

Status: Resolved

Manufacturer: Milbar Laboratories, Inc.

Sold By: physicians; internet sales

Manufactured In: United States

Units Affected: 2 products (952 bottles; 1,348 bottles)

Distributed To: Nationwide

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

What You Should Do

Check your bottle of T Shampoo For Hair and Body (300 ml/10.1 fl. oz.) for lot number MT390-8 (expiration date 12/01/2020) or lot number GU925-4 (expiration date 07/05/2020).

Check your bottle of Zoma Shampoo (300 ml/10.01 fl. oz.) for lot number HT659-6 (expiration date 08/11/2019) or lot number LT168-7 (expiration date 11/10/2019).

If you have an affected product, contact your healthcare provider or pharmacist for guidance regarding your treatment and the effectiveness of the medication.

Return any unused product to the pharmacy or place of purchase for a refund and contact Milbar Laboratories, Inc. at 20 Commerce St, East Haven, CT 06512 for further instructions.

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.

Affected Products

Product: T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar) (300 ml / 10.1 fl. oz.)

Model:

Recall #: D-0832-2018

Lot Numbers:

MT390-8 (Exp 12/01/2020)

GU925-4 (Exp 07/05/2020)

Date Ranges: 12/01/2020, 07/05/2020

Product: Zoma Shampoo, Zinc Pyrithione 1.92% (300 ml / 10.01 fl. oz.)

Model:

Recall #: D-0833-2018

Lot Numbers:

HT659-6 (Exp 08/11/2019)

LT168-7 (Exp 11/10/2019)

Date Ranges: 08/11/2019, 11/10/2019