July 2024 FDA Recall Drug by Granules Consumer Health Inc.
D-0627-2024 - Label mix-up

This Class III drug recall was voluntarily initiated by Granules Consumer Health Inc. on July 18, 2024 for the product Drug. The FDA reported the reason for recall as label mix-up. The product was distributed in Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level. and the recall is currently terminated.

Recall Number: D-0627-2024

Reason for Recall
Label mix-up: Carton incorrectly labeled.
Initiated
07-18-2024
Reported
08-14-2024
Quantity
21,192 Bottles

Recall Profile & Regulatory Data

Event ID About Event ID
Numerical designation assigned by FDA to a specific recall event.
94981
Classification About Classification
Relative degree of health hazard assigned by FDA.
Class III - is a situation in which use of, or exposure to, a violative product is not likely to cause adverse health consequences.
Enforcement Status About Enforcement Status
Current regulatory stage of the recall event.
Terminated
Recalling Firm About Recalling Firm
The firm responsible for the recall.
Granules Consumer Health Inc.
Voluntary / Mandated About Voluntary / Mandated
Indicates if the firm acted on its own or under FDA order.
Voluntary: Firm initiated
Product Type About Product Type
Broad category of product being recalled.
Drugs
Initial Notification About Initial Notification
Method by which the firm first notified the public.
Letter
Distribution Pattern About Distribution Pattern
General area of initial distribution.
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
Termination Date About Termination Date
Date that FDA officially terminated the recall.
02-19-2026
Product Description About Product Description
Full technical description of the product.
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcaps, packaged in a 225-count HDPE bottle, further packaged in a carton, Distributed by Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015, Made in India

Batch or Lot Expiration Information

Lot# : 31670346AA, Exp 12/31/2026