The Recall Desk
ModerateFDA (Drugs)·D-1499-2020·Announced 2020-08-19

Eosera Recalls Ear Pain MD Pain Relief Drops Due to cGMP Deviations

Eosera, Inc. is voluntarily recalling 125,874 bottles of Ear Pain MD Pain Relief Drops with 4% Lidocaine due to current Good Manufacturing Practice (cGMP) deviations.

What this means for you

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: The recall is classified as FDA Class II, which typically involves a reasonable probability of temporary or medically reversible health consequences. The source cites cGMP deviations without reporting specific illnesses or injuries, aligning with a moderate severity rating for a voluntary precautionary recall.

Plain-English summary

Eosera, Inc. is voluntarily recalling 125,874 bottles of Ear Pain MD Pain Relief Drops with 4% Lidocaine (lidocaine HCl Monohydrate 4%) in 0.5 FL OZ (15 mL) bottles. The recall was initiated by the firm on August 4, 2020, and was classified as Class II by the FDA. The reason for the recall is cited as current Good Manufacturing Practice (cGMP) deviations.

The affected product is identified by NDC 72429-0072-2. The recall covers specific lot numbers with expiration dates ranging from September 2020 to November 2021. The full list of affected lot numbers includes P203076, P203075, P203061, P203057, P203047, P203044, P203040, P203033, P203030, P203016, P203015, P203002, P203001, P193053, P203024, P193097, P203017, P193091, P193089, P193088, P193087, P193068, P193067, P193064, P193063, P193062, P193059, P193014, P193057, P193056, P193055, P193011, P193010, P193009, P193008, P193007, P193006, P192005, P193003, P193002, P193001, P183018, and P183017.

The product was distributed nationwide within the United States. The recall status is currently terminated, with a termination date of September 10, 2021. Consumers should check their lot numbers and expiration dates against the list provided to determine if their product is affected.

The recalled product

Product
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
Manufacturer
Eosera, Inc.
Category
Drug — Topical Analgesic
Hazard
Affected units
125,874

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (20)

  • 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

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 4 recalled by Eosera, Inc. under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 4 products in this recall →

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