Recall archive / FDA drug enforcement
Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-297... — FDA record D-0497-2023
Reported terminated
Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.
Source date Mar 20, 2023. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.
Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.
What the record says
- Product
- Tadalafil 5 mg tablets, 30-count bottles, Rx only, Repackaged by: RemedyRepack Inc., Indiana, PA 15701, NDC 70518-2972-00
- Reason
- cGMP Deviations
- Classification
- Class II
- Recalling firm
- RemedyRepack Inc.
- Quantity
- 16 bottles
- Agency-reported status
- Terminated
- Source record identifier
- D-0497-2023
What the recall classes mean. Classification is an agency assessment, not individual medical advice.
Lot and product identifiers
| Label field | Details supplied by the agency |
|---|---|
| Lot, code or applicability | Lot #: B1635780-040522, Exp. Date 04/30/2023 |
Match all identifying details in the current notice. A brand name alone is not enough.
Distribution
RemedyRepack distributed product to consignees nationwide within the United States
States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.
- Alaska
- Alabama
- Arkansas
- Arizona
- California
- Colorado
- Connecticut
- Delaware
- Florida
- Georgia
- Hawaii
- Iowa
- Idaho
- Illinois
- Indiana
- Kansas
- Kentucky
- Louisiana
- Massachusetts
- Maryland
- Maine
- Michigan
- Minnesota
- Missouri
- Mississippi
- Montana
- North Carolina
- North Dakota
- Nebraska
- New Hampshire
- New Jersey
- New Mexico
- Nevada
- New York
- Ohio
- Oklahoma
- Oregon
- Pennsylvania
- Rhode Island
- South Carolina
- South Dakota
- Tennessee
- Texas
- Utah
- Virginia
- Vermont
- Washington
- Wisconsin
- West Virginia
- Wyoming
Dates in the source
- Report date
- Apr 12, 2023
- Recall initiation date
- Mar 20, 2023
- Center classification date
- Mar 31, 2023
- Termination date
- Oct 19, 2023
FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.