Medications & Supplements/Over-the-Counter

Rite Aid, CVS, and Walgreens Earache Drops Recalled for Contamination

Agency Publication Date: June 8, 2022

Summary

Grato Holdings, Inc. is recalling 98,886 bottles of Homeopathic Earache Drops sold under the Rite Aid, CVS Health, and Walgreens brands. The recall was issued because these non-sterile products may be contaminated with microorganisms, which can lead to ear infections. No injuries or illnesses have been reported to date regarding this issue.

Risk

Microbial contamination in ear drops can cause ear infections or other health complications, particularly for people with weakened immune systems or ear injuries. Using contaminated drops in the ear canal presents a medium risk of localized infection.

What You Should Do

This recall affects 0.33 FL OZ (10 mL) bottles of Homeopathic Earache Drops sold under the Rite Aid, CVS Health, and Walgreens brands with lot number G11639 and an expiration date of 09/24.
Identify your product by checking the NDC number on the bottle: Rite Aid (11822-3644-3), CVS Pharmacy (59779-568-15), or Walgreens (0363-3233-15).
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 Grato Holdings, Inc. for further instructions.
Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Homeopathic EarAche Drops (0.33 FL OZ)

Variants: 10 mL

Lot Numbers:

G11639 (Exp. 09/24)

NDC:

11822-3644-3

Distributed by Rite Aid; Recall #: D-0989-2022; Quantity: 16,374 bottles

Product: Homeopathic EarAche Ear Drops (0.33 FL OZ)

Variants: 10 mL

Lot Numbers:

G11639 (Exp. 09/24)

NDC:

59779-568-15

Distributed by CVS Pharmacy, Inc.; Recall #: D-0990-2022; Quantity: 50,640 bottles

Product: Earache Drops (0.33 FL OZ)

Variants: 10 mL

Lot Numbers:

G11639 (Exp. 09/24)

NDC:

0363-3233-15

Distributed by Walgreen Co.; Recall #: D-0991-2022; Quantity: 31,872 bottles

Additional Information

Agency: Food and Drug Administration (FDA)

Event ID: 90297

Status: Resolved

Manufacturer: Grato Holdings, Inc.

Sold By: RITE AID; CVS Pharmacy, Inc.; Walgreen Co.

Manufactured In: United States

Units Affected: 3 products (16,374 bottles; 50,640 bottles; 31,872 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 affects 0.33 FL OZ (10 mL) bottles of Homeopathic Earache Drops sold under the Rite Aid, CVS Health, and Walgreens brands with lot number G11639 and an expiration date of 09/24.

Identify your product by checking the NDC number on the bottle: Rite Aid (11822-3644-3), CVS Pharmacy (59779-568-15), or Walgreens (0363-3233-15).

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 Grato Holdings, Inc. for further instructions.

Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions.

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: Homeopathic EarAche Drops (0.33 FL OZ)

Variants: 10 mL

Lot Numbers:

G11639 (Exp. 09/24)

NDC:

11822-3644-3

Distributed by Rite Aid; Recall #: D-0989-2022; Quantity: 16,374 bottles

Product: Homeopathic EarAche Ear Drops (0.33 FL OZ)

Variants: 10 mL

Lot Numbers:

G11639 (Exp. 09/24)

NDC:

59779-568-15

Distributed by CVS Pharmacy, Inc.; Recall #: D-0990-2022; Quantity: 50,640 bottles

Product: Earache Drops (0.33 FL OZ)

Variants: 10 mL

Lot Numbers:

G11639 (Exp. 09/24)

NDC:

0363-3233-15

Distributed by Walgreen Co.; Recall #: D-0991-2022; Quantity: 31,872 bottles