Severity
Critical
CriticalClass IOngoing
FDA Drug recall · Reported October 13, 2021
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Compiled from official public sources by the editorial team.
Verify with FDA Drug →
Alpha-Tek LLC recalled ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbr… - a critical-severity action.
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbr… was recalled by Alpha-Tek LLC in October 13, 2021. Reason: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil. Check the official notice for the remedy. Verify recall #D-0001-2022 with the FDA Drug before acting.
The recall
Alpha-Tek LLC issued this critical-severity FDA Drug recall-Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil.
- Critical
- severity level
- Class I
- classification
- October 13, 2021
- reported
Sourced from official FDA Drug enforcement records. Verify recall #D-0001-2022 with the agency before acting. Full product description, hazard, remedy, and related recalls are below.
Recall Insight
This FDA Drug action (record #D-0001-2022) was formally reported on October 13, 2021, with the manufacturer initiating the action on July 16, 2021. It is classified under Critical severity (Class I), with a current status of Ongoing. Alpha-Tek LLC is listed as the recalling firm, operating out of Tucson, AZ. Federal records list the affected scope as Unknown.
The documented reason for this recall is: Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil Distribution data in the federal record shows the product reached: Nationwide in the US. 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 - 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.
Food recalls over time
Where this recall sits in its category - 25,126 food 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
Unknown
Related Recalls
6
0 from same agency
Product description
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton)
Reason for recall
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Recall Profile
| Attribute | Value |
|---|---|
| Agency | U.S. Food and Drug Administration |
| Severity class | Critical (Class I) |
| Status | Ongoing |
| Recall number | D-0001-2022 |
| Date reported | October 13, 2021 |
| Date initiated | July 16, 2021 |
| Recalling firm | Alpha-Tek LLC |
| Firm location | Tucson, AZ |
| Affected scope | Unknown |
| Distribution | Nationwide in the US |
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-0001-2022) 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? ▼
ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distributed by Umbrella Labs, Made in the USA, UPC 8 60003 03770 6. Also manufactured for and distributed by: Alpha Male Plus, Tucson, AZ UPC 8 60003 74518 2 (pouch), UPC 8 60003 74512 0(carton). Recalled by Alpha-Tek LLC. Units affected: Unknown.
Why was this product recalled? ▼
Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil
Which agency issued this recall? ▼
This recall was issued by the FDA Drug on October 13, 2021. Severity: Critical. Recall number: D-0001-2022.
Where was the recalled product distributed? ▼
Distribution: Nationwide in the US.
How do I check if my product is affected by a recall? ▼
Check the product description and recall number (D-0001-2022) 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.
CPSC Moderate
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Yamaha Recalls UMAX Bistro and Bistro Deluxe Vehicles Due to Injury Hazard
· 2026-06-11
FDA Food Critical
Butter Parsley Bagel Crisps, Item Number 18490, Net Weight: 10 lbs. Legacy Bakehouse, LLC, N8W22100 Johnson Dr., Wauk…
Legacy Bakehouse LLC · 2026-06-03
Compare this recall with Conair Recalls Over One Million Cuisinart Grill Brushes Due… →
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 13, 2021. 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.