CLASS II Drug recall · Reported 19 Aug 2020 · FDA Enforcement Report
Ear Pain MD Pain Relief Drops For Kids recalled by Eosera
Eosera is recalling Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%), Eosera, Inc. 5000, distributed nationwide in the US. The recall was initiated on 4 Aug 2020 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-1498-2020
- FDA event ID
- 86171
- Recalling firm
- Eosera, Fort Worth, TX
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Aug 2020
- FDA classified
- 13 Aug 2020
- Reported
- 19 Aug 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Pain Medication
Timeline
| 4 Aug 2020 | Recall initiated by company | |
| 13 Aug 2020 | Classified by FDA | +9 days |
| 19 Aug 2020 | Published in enforcement report | +6 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
Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0070-8
Where it was distributed
Nationwide within the United States
Questions about this recall
Why was it recalled?
cGMP Deviations.
Which lots are affected?
Lots: P203093 Exp. DEC 21; P203026 Exp. JUN 21; P193084, P193044, Exp. APR 21; P193073, P193072, P193071, P193070 Exp. FEB 21; P192050 Exp. MAY 21; P193042 Exp. MAR 21; P193013 Exp. JAN 21; P193012 Exp. DEC 20
Where was it sold?
Nationwide within the United States
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
3 other products · FDA event 86171This product is part of a recall event; the main page for the event is Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), Eosera recalled.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), Eosera recalled | Eosera | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Day & Night Pack Ear Itch MD Anti-Itch Spray recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide | |
| CLASS II | Ear Pain MD Pain Relief Drops with 4% Lidocaine recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |
More recalls from Eosera
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ear Pain MD Pain Relief Drops with 4% Lidocaine recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Day & Night Pack Ear Itch MD Anti-Itch Spray recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Ear Itch MD Anti-Itch Spray (pramoxine HCL 1%), Eosera recalled | Eosera | Manufacturing (CGMP) Deviations | Nationwide |
Other Ear pain md pain relief recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ear Pain MD Pain Relief Drops with 4% Lidocaine recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |