Recall archive / FDA drug enforcement

Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 036... — FDA record D-0991-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date May 24, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product: Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC 0363-3233-15
Reason: Microbial contamination of non-sterile product.
Classification: Class II
Recalling firm: Grato Holdings, Inc.
Quantity: 31,872 bottles
Agency-reported status: Terminated
Source record identifier: D-0991-2022

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Lot and product identifiers

Label field	Details supplied by the agency
Lot, code or applicability	Lot #: G11639, Exp. Date 09/24

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide within the USA

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date: Jun 15, 2022
Recall initiation date: May 24, 2022
Center classification date: Jun 8, 2022
Termination date: Jun 8, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.