Severity
Low
LowClass IIITerminated
FDA Drug recall · Reported August 14, 2024
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
Label mix-up: Carton incorrectly labeled.
Granules Consumer Health Inc. recalled Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelc… - a low-severity action.
Acetaminophen, USP 500mg, Pain Reliever/Fever Reducer, Extra Strength, Rapid Release Gelc… was recalled by Granules Consumer Health Inc. in August 14, 2024. Reason: Label mix-up: Carton incorrectly labeled.. Check the official notice for the remedy. Verify recall #D-0627-2024 with the FDA Drug before acting.
The recall
Granules Consumer Health Inc. issued this low-severity FDA Drug recall-Label mix-up: Carton incorrectly labeled..
- Low
- severity level
- Class III
- classification
- August 14, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0627-2024 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0627-2024) was formally reported on August 14, 2024, with the manufacturer initiating the action on July 18, 2024. It is classified under Low severity (Class III), with a current status of Terminated. Granules Consumer Health Inc. is listed as the recalling firm, operating out of Manassas, VA. Federal records list the affected scope as 21,192 Bottles.
The documented reason for this recall is: Label mix-up: Carton incorrectly labeled. Distribution data in the federal record shows the product reached: Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level.. Distribution scope directly affects the consumer exposure window and determines whether a recall remains regional or escalates into a nationwide advisory.
Within the same product category the archive holds 6 closely related recalls, 5 from FDA Drug - clustering in a narrow category often points to a systemic quality-control or supplier issue rather than a one-off defect. Always verify the recall number against the official agency record before acting.
Drugs & Medications recalls over time
Where this recall sits in its category - 14,287 drugs & medications recalls on record
Of 101,704 recalls in the database, 24,878 are high severity, 72,426 moderate, and 4,400 low. This recall is classified low severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
21,192 Bottles
Related Recalls
6
5 from same agency
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
Reason for recall
Label mix-up: Carton incorrectly labeled.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Low (Class III) |
| Status | Terminated |
| Recall number | D-0627-2024 |
| Date reported | August 14, 2024 |
| Date initiated | July 18, 2024 |
| Recalling firm | Granules Consumer Health Inc. |
| Firm location | Manassas, VA |
| Affected scope | 21,192 Bottles |
| Distribution | Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level. |
Profile values are sourced directly from the official FDA Drug enforcement record. Source: U.S. Food and Drug Administration.
What to do with this recall
Match your product against the recall record, then act on the agency remedy.
- Check the recall number (D-0627-2024) and product description against the item you own. Search the archive
- Confirm the current status with FDA Drug before acting, recall details can be updated.
- Follow the documented remedy (refund, replacement, repair, or disposal) rather than general advice. What to do next
This page summarizes the official FDA Drug record for research and awareness; it is not legal, medical, or safety advice. Verify with the issuing agency before acting.
Frequently Asked Questions
What product was recalled? ▼
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. Recalled by Granules Consumer Health Inc.. Units affected: 21,192 Bottles.
Why was this product recalled? ▼
Label mix-up: Carton incorrectly labeled.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on August 14, 2024. Severity: Low. Recall number: D-0627-2024.
Where was the recalled product distributed? ▼
Distribution: Recalled lot was distributed to one distributor in IL who may have further distributed the product to the retail level..
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0627-2024) against your product. Visit the official FDA Drug website for the most current information. You can also use our Recall Checker tool to search by product name or brand.
Should I stop using a recalled medication or medical device? ▼
Do not stop using a recalled medication or device without consulting your healthcare provider first, as abruptly discontinuing treatment could pose its own health risks. Your doctor can advise on alternatives or whether the recall applies to your specific product lot. Check the recall number and lot information against your product packaging.
Nearby Recalls in This Category
Other recalls in the same product category, useful for spotting patterns across the same defect class or manufacturer.
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Compare this recall with PRED MILD, prednisolone acetate ophthalmic suspension, USP,… →
Every figure on PlainRecalls is rendered directly from official FDA, CPSC and NHTSA recall records, no number is typed in by an editor. This recall: FDA Drug, reported August 14, 2024. Severity classes follow each agency's own taxonomy (FDA Class I/II/III; CPSC and NHTSA by hazard type), and related-recall context is computed across the full archive. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error. Data current as of July 2026.