CLASS II Drug recall · Reported 5 Jul 2023 · FDA Enforcement Report
DoloEar Earache Drops recalled by Homeocare Laboratories
Homeocare Laboratories is recalling DoloEar Earache Drops, 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-0884-2023
- 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
DoloEar Earache Drops, 0.50 fl. oz. bottles, Distributed by Pharmadel LLC, Georgetown, DE NDC 55758-001-15
Where it was distributed
Product was distributed USA nationwide.
Questions about this recall
Is DoloEar Earache Drops recalled?
Yes. Homeocare Laboratories recalled DoloEar Earache Drops on 5 Jun 2023. The recall is Class II and its status is Terminated. Recall number D-0884-2023.
Why was it recalled?
cGMP deviations
Which lots are affected?
Lot # 2423, exp. date Nov-24; 2445, exp. date Apr-25
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.
More recalls from Homeocare Laboratories
All 12| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Stellalife Advanced Formula Peppermint, Vega Oral Care, Rinse recalledStellalife Vega Oral Care Peppermint | Homeocare Laboratories | Sterility | Nationwide |
| Drug | CLASS II | Kanjo Homeopathic Pain Relief Cream With Arnica recalled | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | StellaLife VEGA Oral Care Gel tubes recalled by Homeocare Laboratories | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | StellaLife VEGA Oral Care Rinse, Peppermint recalledStellalife Vega Oral Care Rinse | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | StellaLife VEGA Oral Care Spray recalled by Homeocare Laboratories | Homeocare Laboratories | Manufacturing (CGMP) Deviations | Nationwide |
Other Doloear earache recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | DoloEar Earache Drops, Homeopathic fl recalled by Pharmadel | Pharmadel | Manufacturing (CGMP) Deviations | DE |