CLASS II Drug recall · Reported 5 Jul 2023 · FDA Enforcement Report
Bebelyn Colic Drops Homeopathic Remedy recalled
Homeocare Laboratories is recalling Bebelyn Colic Drops Homeopathic Remedy, distributed nationwide in the US. The recall was initiated on 5 Jun 2023 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0882-2023
- FDA event ID
- 92453
- Recalling firm
- Homeocare Laboratories, Yonkers, NY
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Jun 2023
- FDA classified
- 26 Jun 2023
- Reported
- 5 Jul 2023
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
Timeline
| 5 Jun 2023 | Recall initiated by company | |
| 26 Jun 2023 | Classified by FDA | +21 days |
| 5 Jul 2023 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
cGMP deviations
Product as listed by the FDA
Bebelyn Colic Drops Homeopathic Remedy, 0.5 FL Oz (15 mL) bottles, distributed by Pharmadel LLC Georgetown, DE NDC 55758-036-01
Where it was distributed
Product was distributed USA nationwide.
Questions about this recall
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot # 2414, exp. date Sep-24
Where was it sold?
Product was distributed USA nationwide.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other products in this recall event
10 other products · FDA event 92453This product is part of a recall event; the main page for the event is Arnica 7 Cream recalled by Homeocare Laboratories.
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