CLASS II Drug recall · Reported 19 Aug 2020 · FDA Enforcement Report
Ear Pain MD Pain Relief Drops with 4% Lidocaine recalled by Eosera
Eosera is recalling Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%), Eosera, 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-1499-2020
- 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 with 4% Lidocaine (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eosera, Inc. 5000 South Freeway Fort Worth, TX 76115, NDC 72429-0072-2
Where it was distributed
Nationwide within the United States
Questions about this recall
Is Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%), Eosera recalled?
Yes. Eosera recalled Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%), Eosera on 4 Aug 2020. The recall is Class II and its status is Terminated. Recall number D-1499-2020.
Why was it recalled?
cGMP Deviations.
Which lots are affected?
Lot #: P203076, P203075 Exp. NOV 21; P203061, P203057 Exp. AUG 21; P203047, P203044, P203040, JUL 21; P203033, P203030, P203016, P203015, P203002, P203001, P193053 Exp. JUN 21; P203024, P193097 Exp. MAY 21; P203017 Exp. JUL 20; P193091, P193089, P193088, P193087 Exp. APR 21; P193068, P193067 Exp. FEB 21; P193064, P193063, P193062, P193059, P193014 Exp. JAN 21; P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001, Exp. DEC 20; P183018, P183017 Exp. SEP 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.
More recalls from Eosera
All 4| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ear Pain MD Pain Relief Drops For Kids 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 For Kids recalled by Eosera | Eosera | Manufacturing (CGMP) Deviations | Nationwide |