Homeopathic drug Bebelyn Colic Drops recalled for manufacturing deviations
Bebelyn Colic Drops homeopathic remedy is recalled due to Current Good Manufacturing Practice deviations. Approximately 5,956 bottles were distributed nationwide.
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 Class II recall with no reported illnesses or injuries. The recall was voluntarily initiated by the manufacturer due to manufacturing process deviations, making it a precautionary recall appropriate for the 'Moderate' severity category where no specific harm has been documented.
Plain-English summary
Bebelyn Colic Drops Homeopathic Remedy, distributed in 0.5 FL Oz (15 mL) bottles under NDC 55758-036-01, is being recalled. The product is manufactured by Homeocare Laboratories, Inc., and distributed by Pharmadel LLC of Georgetown, Delaware.
The recall was initiated due to Current Good Manufacturing Practice (cGMP) deviations identified during manufacturing. Homeocare Laboratories voluntarily initiated the recall on June 5, 2023. The FDA classified the recall as Class II on June 26, 2023.
Approximately 5,956 bottles with Lot #2414 and expiration date September 2024 were distributed nationwide throughout the United States. The recall was terminated on September 16, 2024.
The recalled product
- Product
- Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
- Manufacturer
- Homeocare Laboratories, Inc.
- Category
- Drug — Homeopathic Remedy
- Hazard
- manufacturing-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 (2)
- Lot # 2414
- exp. date Sep-24
Distribution
Distributed nationwide across the United States.
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