CLASS I Drug recall · Reported 23 Feb 2022 · FDA Enforcement Report
MAC Daddy RED Capsules recalled by ABC Sales 1
ABC Sales 1 is recalling MAC Daddy RED Capsules, distributed nationwide in the US. The recall was initiated on 8 Feb 2022 and the FDA has classified it as Class I.
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-0562-2022
- FDA event ID
- 89558
- Recalling firm
- ABC Sales 1, Monsey, NY
- Classification
- Class I
- Status
- Terminated
- Recall initiated
- 8 Feb 2022
- FDA classified
- 17 Feb 2022
- Reported
- 23 Feb 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Press Release
- Reason category
- Labeling Errors
Timeline
| 8 Feb 2022 | Recall initiated by company | |
| 17 Feb 2022 | Classified by FDA | +9 days |
| 23 Feb 2022 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Product as listed by the FDA
MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLDZLY2, UPC 742137 605191.
Where it was distributed
Product was distributed nationwide in the USA via Amazon Marketplace.
Stores named: Amazon
Questions about this recall
Is MAC Daddy RED Capsules recalled?
Yes. ABC Sales 1 recalled MAC Daddy RED Capsules on 8 Feb 2022. The recall is Class I and its status is Terminated. Recall number D-0562-2022.
Why was it recalled?
Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or sildenafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making these unapproved drugs.
Which lots are affected?
Lot # 1230004, Exp. date 03/30/2024
Where was it sold?
Product was distributed nationwide in the USA via Amazon Marketplace.
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 I mean?
Class I is the most serious FDA recall category: there is a reasonable probability that using the product will cause serious health consequences or death.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from ABC Sales 1
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Mac Daddy Purple Capsules recalled by ABC Sales 1 | ABC Sales 1 | Labeling Errors | Nationwide |