CLASS III Drug recall · Reported 14 Aug 2024 · FDA Enforcement Report
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer recalled
Granules Consumer Health is recalling Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release, distributed in Illinois. The recall was initiated on 18 Jul 2024 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0627-2024
- FDA event ID
- 94981
- Recalling firm
- Granules Consumer Health, Manassas, VA
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 18 Jul 2024
- FDA classified
- 6 Aug 2024
- Reported
- 14 Aug 2024
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Labeling Errors
- Drug class
- Pain Medication
Timeline
| 18 Jul 2024 | Recall initiated by company | |
| 6 Aug 2024 | Classified by FDA | +19 days |
| 14 Aug 2024 | Published in enforcement report | +8 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Label mix-up: Carton incorrectly labeled.
Product as listed by the FDA
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
Where it was distributed
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
Questions about this recall
Why was it recalled?
Label mix-up: Carton incorrectly labeled.
Which lots are affected?
Lot #: 31670346AA, Exp 12/31/2026
Where was it sold?
Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
Other Acetaminophen recalls
All 63| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Tylenol, Acetaminophen, Extra Strength, 24 Caplets, 500mg each recalledTylenol Extra Strength | Kenvue Brands | Other | Nationwide |
| Drug | CLASS II | Acetaminophen Injection 1000 mg/ (10 mg/mL) recalledAcetaminophen | Baxter Healthcare | Packaging Defects | Nationwide |
| Drug | CLASS II | Acetaminophen Tablets, 325 mg recalled by Aurobindo Pharma USAAmazon Basic Care Acetaminophen | Aurobindo Pharma USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Acetaminophen and Ibuprofen (Nsaid) Tablets, 250 mg/125 mg a) recalledAcetaminophen, Ibuprofen | Glenmark Pharmaceuticals Inc., USA | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Kirkland Severe Cold & Flu Plus Congestion: Day - 112 coated caplets recalledSevere Cold And Flu Plus Congestion | LNK International | Manufacturing (CGMP) Deviations | Nationwide |