Homeopathic diarrhea remedy recalled due to manufacturing control deviations
Homeocare Laboratories is recalling Babelyn Diarrhea Drops due to manufacturing control (cGMP) deviations. The voluntary recall affects 5,957 bottles 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: This is a Class II voluntary recall for cGMP deviations with no reported illnesses or injuries. The rubric indicates that voluntary precautionary recalls typically score 2 (Moderate).
Plain-English summary
Homeocare Laboratories, Inc. is recalling Babelyn Diarrhea Drops Homeopathic Remedy, a liquid homeopathic preparation supplied in 0.5 fl. oz. (15 mL) bottles. The affected product was distributed nationwide by Pharmadel LLC under NDC 55758-035-01. The specific lot involved is Lot #2413 with an expiration date of September 2024.
The recall was initiated due to deviations from current Good Manufacturing Practice (cGMP) requirements. These manufacturing control deviations affect the product's quality assurance standards, though no illnesses or injuries have been reported to date.
The recall was voluntary and initiated by the manufacturer on June 5, 2023. It was classified as Class II by the FDA and terminated on September 16, 2024. Approximately 5,957 bottles were involved in the recall.
Consumers should stop using this product if they have the affected lot and bottle. Consumers with questions should contact Homeocare Laboratories, Inc. or consult their healthcare provider.
The recalled product
- Product
- Babelyn Diarrhea Drops Homeopathic Remedy, 0.5 fl. oz. (15 mL) bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-035-01
- Manufacturer
- Homeocare Laboratories, Inc.
- Category
- Drug — Homeopathic Remedy
- Hazard
- Affected units
- 5,957
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 # 2413
- exp. date Sep-24
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 11 recalled by Homeocare Laboratories, 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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