Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported October 9, 2024
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Supercore Products Group Inc. recalled Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufact… - a critical-severity action.
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufact… was recalled by Supercore Products Group Inc. in October 9, 2024. Reason: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophe…. Check the official notice for the remedy. Verify recall #D-0003-2025 with the FDA Drug before acting.
The recall
Supercore Products Group Inc. issued this critical-severity FDA Drug recall-Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophe….
- Critical
- severity level
- 729 units
- affected scope
- Class I
- classification
- October 9, 2024
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0003-2025 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0003-2025) was formally reported on October 9, 2024, with the manufacturer initiating the action on July 12, 2024. It is classified under Critical severity (Class I), with a current status of Ongoing. Supercore Products Group Inc. is listed as the recalling firm, operating out of Atlanta, GA. Federal records list the affected scope as 729.
The documented reason for this recall is: Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil. Distribution data in the federal record shows the product reached: Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1). 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 high severity.
Counts reflect market size and reporting activity, not inherent danger, we do not rank products by risk from raw recall volume.
Affected scope
729
Related Recalls
6
5 from same agency
Product description
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.
Reason for recall
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0003-2025 |
| Date reported | October 9, 2024 |
| Date initiated | July 12, 2024 |
| Recalling firm | Supercore Products Group Inc. |
| Firm location | Atlanta, GA |
| Affected scope | 729 |
| Distribution | Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1) |
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-0003-2025) 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.
- This is a Class I (high-risk) recall, stop using the product immediately and follow the disposal or return instructions. 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? ▼
Hard Steel Capsules packaged in 1 count blister packs in boxes of 10, 20 and 30, Manufactured in U.S.A.. Recalled by Supercore Products Group Inc.. Units affected: 729.
Why was this product recalled? ▼
Marketed without an approved NDA/ANDA: FDA analysis found products to be tainted with undeclared acetaminophen and sildenafil.
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 9, 2024. Severity: Critical. Recall number: D-0003-2025.
Where was the recalled product distributed? ▼
Distribution: Nationwide US (2014), Israel (2), Canada (12), Republic of Kosovo (1), Pakistan (1), Australia (3), Morocco (1), United Kingdom (1).
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0003-2025) 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 October 9, 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.