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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Low RiskFDA Drug
Medications & Supplements/Over-the-Counter

Walgreens Extra Strength Acetaminophen Gelcaps Recalled for Labeling Mix-up

Agency Publication Date: August 6, 2024
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Summary

Granules Consumer Health Inc. is recalling 21,192 bottles of Walgreens brand Extra Strength Acetaminophen (500mg) Rapid Release Gelcaps. The 225-count bottles, which are packaged inside cartons, were incorrectly labeled due to a label mix-up. Consumers who use this medication should check their packaging to ensure they have the correct labeling information.

Risk

The carton labeling for the product is incorrect, which could lead to confusion about the product's dosage or use. There have been no reported injuries or adverse events related to this labeling error.

What You Should Do

  1. This recall affects 225-count bottles of Walgreens brand Acetaminophen USP 500mg Extra Strength Rapid Release Gelcaps with lot number 31670346AA and an expiration date of 12/31/2026.
  2. If you have health concerns regarding the use of this medication, contact your healthcare provider or pharmacist.
  3. Return any unused product to the place of purchase for a refund, throw it away, or contact Granules Consumer Health Inc. for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) for additional questions regarding this recall.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelcapsby Walgreens
Variants: 500mg, Extra Strength, Rapid Release Gelcaps, 225-count bottle
Lot Numbers:
31670346AA (Exp 12/31/2026)

Distributed by Walgreen Co.; Packaged in a 225-count HDPE bottle inside a carton.

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 94981
Status: Resolved
Manufacturer: Granules Consumer Health Inc.
Sold By: Walgreens
Manufactured In: India
Units Affected: 21,192 Bottles
Distributed To: Illinois

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.