Walgreens Earache Drops recalled for microbial contamination of non-sterile product
Walgreens Earache Drops are recalled due to microbial contamination in the non-sterile product. Consumers should stop using the product and consult a healthcare provider if they experience any adverse effects.
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: FDA Class II recall for microbial contamination in a non-sterile product intended for direct application to the ear canal. While no illnesses or injuries have been reported, the product presents a concrete risk of infection.
Plain-English summary
Walgreens Earache Drops, distributed by Walgreen Co., are being recalled due to microbial contamination in the non-sterile product. The recall involves 31,872 bottles of the 0.33 FL OZ (10 mL) formulation with Lot #G11639 and an expiration date of 09/24, distributed nationwide across the United States.
The product is manufactured by Grato Holdings, Inc. Consumers should stop using this product immediately and consult their healthcare provider if they have experienced any ear-related symptoms or adverse effects after using the recalled product.
The recalled product
- Product
- WALGREENS EARACHE DROPS (BELLADONNA LEAF, CALCIUM CARBONATE, CHAMOMILE, LYCOPODIUM CLAVATUM SPORE, ANEMONE PATENS, AND SULFUR)
- Brand
- WALGREENS EARACHE DROPS
- Manufacturer
- Grato Holdings, Inc.
- Category
- Drug
- Hazard
- Affected units
- 31,872
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)
- 0311917217123
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.
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