Homeopathic Ear Drops Recalled Due to Microbial Contamination Risk
EAR CARE EARACHE DROPS are being recalled nationwide due to potential microbial contamination. Rite Aid is recalling 16,374 bottles of the homeopathic otic product.
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: Microbial contamination of a non-sterile otic product represents a risk of potential harm to consumers. No illnesses or injuries have been reported. FDA Class II classification applies, but severity falls to High (3) due to absence of reported illness.
Plain-English summary
EAR CARE EARACHE DROPS, a homeopathic otic product, are being recalled due to microbial contamination in a non-sterile product. The FDA has classified this as a Class II recall.
The affected product is distributed by Rite Aid. Approximately 16,374 bottles are involved, with lot number G11639 and expiration date 09/24. Distribution occurred nationwide within the USA.
Consumers who have purchased this product should discontinue use. Patients experiencing any symptoms potentially related to use of the recalled product should seek medical attention. For further instructions, consumers may contact Rite Aid or the manufacturer, Grato Holdings, Inc.
The recalled product
- Product
- EAR CARE EARACHE DROPS (ATROPA BELLADONNA, ANEMONE PULSATILLA, LYCOPODIUM CLAVATUM SPORE, MATRICARIA CHAMOMILLA, AND SULFUR)
- Brand
- EAR CARE EARACHE DROPS
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug — Homeopathic Otic Product
- Hazard
- Affected units
- 16,374
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
UPCs (1)
- 0011822364430
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 →Related recalls
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