The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0990-2022·Announced 2022-06-15

Homeopathic EarAche Ear Drops Recalled for Microbial Contamination

CVS Pharmacy is recalling Homeopathic EarAche Ear Drops (lot #G11639, exp. 09/24) due to microbial contamination detected in the non-sterile product. Consumers should stop using affected bottles.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: The FDA classified this as a Class II recall involving a non-sterile product with documented microbial contamination. Although no illnesses or injuries are reported in the source, the risk-of-harm profile—contamination in a product for ear use near mucous membranes—meets the rubric criterion for High severity.

Plain-English summary

Grato Holdings, Inc., distributed by CVS Pharmacy, Inc., is recalling Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, nationwide. The recall affects approximately 50,640 units with lot number G11639 and expiration date 09/24 (NDC 59779-568-15).

The product has been found to contain microbial contamination. Because these ear drops are non-sterile and intended for use in or near the ear, the microbial contamination poses a potential health risk.

The affected product was distributed nationwide within the United States. Consumers who have purchased this product should discontinue use immediately. Consumers with questions or concerns should consult their healthcare provider.

The recalled product

Product
Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-568-15
Manufacturer
Grato Holdings, Inc.
Category
Drug — Ear Drops
Hazard
Affected units
50,640

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (2)

  • Lot #: G11639
  • Exp. Date 09/24

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 recalled by Grato Holdings, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 3 products in this recall →

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