Ear Pain MD Kids Drops (Eosera) – manufacturing deviation (2020)
Class II: A situation in which use of, or exposure to, a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote
Class II recall indicates potential for temporary health effects.
This AI-generated summary is provided for general informational purposes only and is derived from publicly available recall notices. It supplements but does not replace official agency classifications or safety instructions.
Check Your Product
According to the U.S. Food and Drug Administration (FDA)
Product
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
Brand
Eosera, Inc.
Lot Codes / Batch Numbers
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
Products Sold
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
Eosera, Inc. is recalling Ear Pain MD Pain Relief Drops For Kids (lidocaine HCl Monohydrate 4%) 0.5 FL OZ (15 mL) bottles, Eos due to cGMP Deviations.. This is a Class I recall, indicating a high risk of serious health consequences. Based on FDA drug enforcement report.
Summary derived from FDA notice
Reason for Recall
As stated by FDA
cGMP Deviations.
Recommended Action
Per FDA guidance
Consumers should stop using the product and contact the recalling firm, their healthcare provider, or return it to the place of purchase.
Verify this information on the official source
For complete details and official instructions, check the U.S. Food and Drug Administration (FDA) directly.
View official FDA recall noticePage updated: Jan 7, 2026