DoloEar Homeopathic Earache Drops Recalled for cGMP Deviations
Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops (0.50 oz, 15 mL) due to cGMP (current Good Manufacturing Practice) deviations. The recall affects 27,648 bottles distributed in Delaware.
What this means for you
Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.
Our severity reasoning: FDA classified this as Class II. The recall is for manufacturing practice deviations (cGMP), which is a systemic manufacturing concern; however, no specific hazard (such as contamination or harmful ingredient) is identified, and no illnesses or injuries are reported in the source text.
Plain-English summary
Pharmadel, LLC is recalling DoloEar Homeopathic Earache Drops, 0.50 oz fl (15 mL), NDC 55758-401-15. The recall was initiated on April 15, 2025, due to cGMP (current Good Manufacturing Practice) deviations. The affected product was distributed in Delaware.
The recall involves 27,648 bottles across two lots: DEE-01 (expiration October 2026) and DEE-02 (expiration February 2027). This is a voluntary recall initiated by the firm and was classified as FDA Class II.
Consumers who have purchased DoloEar Earache Drops should stop use and consult their healthcare provider if they have any concerns about the product. The recall was terminated on January 8, 2026.
The recalled product
- Product
- DoloEar Earache Drops, Homeopathic, 0.50 oz fl (15 mL), Distributed by: Pharmadel, New Castle, DE 19720, NDC 55758-401-15
- Manufacturer
- Pharmadel, LLC
- Hazard
- cgmp-deviation
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 (4)
- Lot
- expiry: DEE-01
- EXP: OCT 26
- DEE-02 EXP: FEB 27
Distribution
Distributed in 1 state:
- DE
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