Why it was recalled
Label mix-up: Carton incorrectly labeled.
Product description
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
Lot numbers, UPCs & expiration codes
Lot #: 31670346AA, Exp 12/31/2026
Where it was sold
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
What to do if you have this product
- Compare the lot number and expiration date on your package with the codes above.
- Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
- If you have symptoms you think are related, contact your doctor. In an emergency call 911.
- Report side effects to FDA MedWatch at 1-800-FDA-1088.
Recall details
- Recall number
- D-0627-2024
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- Jul 18, 2024
- FDA report date
- Aug 14, 2024
- Quantity
- 21,192 Bottles
- Recall type
- Voluntary: Firm initiated
- Recalling firm
- Granules Consumer Health Inc.
Original FDA data
Every field from FDA enforcement report D-0627-2024, exactly as published.
Show all FDA fields
- City
- Manassas
- State
- VA
- Status
- Terminated
- Country
- United States
- Event ID
- 94981
- Address
- 7413 Cushing Rd Ste 145
- Code information
- Lot #: 31670346AA, Exp 12/31/2026
- Postal code
- 20109
- Report date
- Aug 14, 2024
- Product type
- Drugs
- Recall number
- D-0627-2024
- Classification
- Class III
- Recalling firm
- Granules Consumer Health Inc.
- Product quantity
- 21,192 Bottles
- Termination date
- Feb 19, 2026
- Reason for recall
- Label mix-up: Carton incorrectly labeled.
- Voluntary / mandated
- Voluntary: Firm initiated
- Product description
- 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
- Distribution pattern
- Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
- Recall initiation date
- Jul 18, 2024
- Initial firm notification
- Letter
- Center classification date
- Aug 6, 2024