Acetaminophen recall
FDA recall D-0627-2024 · initiated Jul 18, 2024
Granules Consumer Health Inc. recalled Acetaminophen in Jul 2024 — an FDA Class III recall (D-0627-2024) because Label mix-up: Carton incorrectly labeled.
Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
Why it was recalled
Label mix-up: Carton incorrectly labeled.
Labelling, packaging or a product mix-up
The wrong information — or the wrong medicine — ended up in the pack. A mix-up is a manufacturing failure that can still be dangerous to swallow.
This is a manufacturing or quality failure, not a finding that the medicine is unsafe to take — across every recall we hold, none was issued for that reason. It does not mean the batch was harmless.
Is your product affected? Check the lot number
A recall covers only specific lots. Find the lot number and expiration date on your package and compare them to the affected codes below — if yours is not listed, it was not part of this recall.
Quantity recalled: 21,192 Bottles
Details
- 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
- Recalling company
- Granules Consumer Health Inc.
- Classification
- Class III
- Status
- Terminated
- Type
- Voluntary: Firm initiated
- Distribution
- Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
- Initiated
- Jul 18, 2024
- FDA report date
- Aug 14, 2024
Frequently asked
- Was Acetaminophen recalled?
- Granules Consumer Health Inc. recalled Acetaminophen in Jul 2024 — an FDA Class III recall (D-0627-2024) because Label mix-up: Carton incorrectly labeled. Unlikely to cause harm but violates FDA labeling or manufacturing regulations.
- Why was Acetaminophen recalled?
- Per the FDA enforcement record, the reason for recall D-0627-2024 was: Label mix-up: Carton incorrectly labeled.
- Is a recalled Acetaminophen dangerous to take?
- An FDA recall removes specific lots from the market for a defined reason and does not by itself mean the medicine is unsafe for everyone — your specific lot may never have been affected. Unlikely to cause harm but violates FDA labeling or manufacturing regulations. Check the FDA notice for the affected lot numbers and expiration dates, and ask your pharmacist or doctor before stopping a prescribed medicine. This reproduces public FDA data and is not medical advice.
- Which lots of Acetaminophen are affected?
- Distributed: Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.. The recall covers these lots — Lot #: 31670346AA, Exp 12/31/2026. Check the lot number and expiration date on your package against this list; if yours is not listed, it was not part of recall D-0627-2024.