Skip to content
Back to recalls
Drug FDA Class III Terminated Mislabeling

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

Granules Consumer Health Inc. Published Aug 14, 2024

Risk level

Class III

Unlikely to cause harm, but violates labeling or manufacturing rules.

Severity score 25/100

What should you do?

  • Check whether you have this product, using the lot codes, UPCs, and dates listed below.
  • Do not eat, serve, or sell the affected product.
  • Return it to the place of purchase for a refund, or throw it away in a sealed bag so people and animals can’t get to it.
  • Contact Granules Consumer Health Inc. or your place of purchase with questions, and see the source record below for full details.
Reason for recall

Label mix-up: Carton incorrectly labeled.

Affected products (1)

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

21,192 Bottles

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

Affected areas

Illinois

Timeline

  1. Initiated
    Jul 18, 2024
  2. Published
    Aug 14, 2024
  3. Terminated
    Feb 19, 2026
Recall number
D-0627-2024
Agency
U.S. Food and Drug Administration
Country
US
Source data (openFDA JSON) About FDA enforcement reports

FDA records come from the openFDA drug enforcement-report dataset — the agency's full weekly enforcement list. Most entries are not issued as consumer press releases, so they won't appear on fda.gov/recalls or in a web search. The source record link above resolves this exact recall by its number.