Medications & Supplements/Topical Products

Amneal Fluocinolone Acetonide Topical Oil Recalled for Subpotency

Agency Publication Date: November 16, 2021

Summary

Amneal Pharmaceuticals of New York, LLC has recalled 9,354 bottles of Fluocinolone Acetonide 0.01% Topical Oil, which includes both Body Oil and Scalp Oil formulations. This prescription medication is used to treat skin conditions, but testing revealed that these lots were subpotent, meaning they do not contain the full required amount of the active ingredient. No injuries or incidents have been reported in connection with this recall.

Risk

A subpotent drug may not effectively treat the medical condition for which it was prescribed, potentially leading to a lack of improvement or a worsening of skin symptoms. Patients using this medication might not receive the intended therapeutic benefit.

What You Should Do

This recall involves 4 oz. bottles of Amneal Fluocinolone Acetonide 0.01% Topical Oil, sold as Body Oil (NDC 65162-704-86) and Scalp Oil (NDC 65162-703-86).
Check the lot number and expiration date printed on your bottle to see if your medication is affected. Recalled Body Oil uses lot number 07040001A (Exp 02/2022) and recalled Scalp Oil uses lot number 07030002A (Exp 02/2022).
If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals of New York, LLC for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fluocinolone Acetonide 0.01% Topical Oil, Body Oil (4 oz.)

Variants: Body Oil, Rx, 0.01%

Lot Numbers:

07040001A (Exp 02/2022)

NDC:

65162-704-86

Recall #: D-0233-2022; Quantity: 7,766 bottles

Product: Fluocinolone Acetonide 0.01% Topical Oil, Scalp Oil (4 oz.)

Variants: Scalp Oil, Rx, 0.01%

Lot Numbers:

07030002A (Exp 02/2022)

NDC:

65162-703-86

Recall #: D-0234-2022; Quantity: 1,588 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 88997

Status: Resolved

Manufacturer: Amneal Pharmaceuticals of New York, LLC

Sold By: Pharmacies

Manufactured In: United States

Units Affected: 2 products (7,766 bottles; 15,88 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

What You Should Do

This recall involves 4 oz. bottles of Amneal Fluocinolone Acetonide 0.01% Topical Oil, sold as Body Oil (NDC 65162-704-86) and Scalp Oil (NDC 65162-703-86).

Check the lot number and expiration date printed on your bottle to see if your medication is affected. Recalled Body Oil uses lot number 07040001A (Exp 02/2022) and recalled Scalp Oil uses lot number 07030002A (Exp 02/2022).

If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Amneal Pharmaceuticals of New York, LLC for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) or visit www.fda.gov/safety/recalls for additional information.

Your Remedy Options

You have 2 options:

Option 1: Full Refund

How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund

Option 2: Dispose of Product

How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Fluocinolone Acetonide 0.01% Topical Oil, Body Oil (4 oz.)

Variants: Body Oil, Rx, 0.01%

Lot Numbers:

07040001A (Exp 02/2022)

NDC:

65162-704-86

Recall #: D-0233-2022; Quantity: 7,766 bottles

Product: Fluocinolone Acetonide 0.01% Topical Oil, Scalp Oil (4 oz.)

Variants: Scalp Oil, Rx, 0.01%

Lot Numbers:

07030002A (Exp 02/2022)

NDC:

65162-703-86

Recall #: D-0234-2022; Quantity: 1,588 bottles