Independent register of U.S. FDA drug recalls · updated Oct 10, 2026
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Class II · Moderate risk Terminated Initiated May 24, 2022 (4 years ago)

Earache Drops

Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.

Why it was recalled

Microbial contamination of non-sterile product.

Cause type: Microbial contamination

Bacteria, mold, yeast or other microorganisms detected in the product. Contamination can occur from water systems, equipment or handling, and can cause infection. All microbial contamination recalls.

What was recalled

Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15

Affected NDC 0363-3233-15

Compare with the code on your package — it is the most precise check available.

Product details

From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.

ProductStrengthForm & routeLabelerType
Walgreens Earache Drops
belladonna leaf, calcium carbonate, chamomile, lycopodium clavatum spore, anemone patens, and sulfur
NDC 00363-3233
BELLADONNA LEAF 30 [hp_C]/mL; CALCIUM CARBONATE 30 [hp_C]/mL; CHAMOMILE 30 [hp_C]/mL; LYCOPODIUM CLAVATUM SPORE 30 [hp_C]/mL; ANEMONE PATENS WHOLE 30 [hp_C]/mL; SULFUR 30 [hp_C]/mL Liquid
Auricular (otic)
Walgreen Company OTC
Recalling firm
Grato Holdings, Inc.
NDC code
0363-3233-15
Origin
IA, United States
Initiated by
Voluntary: Firm initiated
FDA recall number
D-0991-2022 · FDA notice

Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.

Other recalls by Grato Holdings, Inc.

All 2022 recalls
Class III · Low risk

V-FORCE Homeopathic

Incorrect Product Formulation: product contains Active Ingredient Glandula Suprarenalis Suis 8X instead of Glandula Suprarenalis Bovine 8X (as stated on the product label).

Terminated cGMP deviation Grato Holdings, Inc. D-0099-2024

Other microbial contamination recalls from 2022

All microbial contamination recalls
Class I · High risk

Easy Care First Aid 10 Person 2009 ANSI

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0253-2023
Class I · High risk

CVS First Aid Home

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0252-2023
Class I · High risk

Easy Care First Aid 25 Person 2009 ANSI

Microbial Contamination of Non-Sterile Products: FDA Laboratory results found product to be contaminated with Bacillus lichenformis and Bacillus sonorensis.

Terminated Microbial contamination GFA Production Xiamen Co. Ltd. D-0251-2023