Recall archive / FDA drug enforcement

Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-c... — FDA record D-0415-2023

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 Feb 7, 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 Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-count bottle NDC 16729-370-16, UPC 3 16729 37016 5; Manufactured for: Accord Healthcare, Inc., Durham, NC 27703. Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 INDIA
Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Classification: Class II
Recalling firm: Accord Healthcare, Inc.
Quantity: 1,113,264 bottles
Agency-reported status: Terminated
Source record identifier: D-0415-2023

Open the official record

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	Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040, Exp. Date 8/31/2023; P2005039, Exp. Date 8/31/2023; P2005041, Exp. Date 8/31/2023; P2005606, Exp. Date 9/30/2023; P2100340, Exp. Date 9/30/2023; P2100009, Exp. Date 12/31/2023; P2100010, Exp. Date 12/31/2023; P2100044, Exp. Date 12/31/2023; P2100045, Exp. Date 12/31/2023; P2100046, Exp. Date 12/31/2023; P2101129, Exp. Date 1/31/2024; P2101880, Exp. Date 1/31/2024; P2101130, Exp. Date 1/31/2024; P2101131, Exp. Date 1/31/2024; P2106689, Exp. Date 9/30/2024; P2106691, Exp. Date 9/30/2024; P2203585, Exp. Date 6/30/2025; b) P2002451 Exp. Date 4/30/2023; P2005365, Exp. Date 8/31/2023; P2005036, Exp. Date 8/31/2023; P2005037, Exp. Date 8/31/2023; P2005607, Exp. Date 9/30/2023; P2005608, Exp. Date 9/30/2023; P2100048, Exp. Date 12/31/2023; P2100052, Exp. Date 12/31/2023; P2100053, Exp. Date 12/31/2023; P2100055, Exp. Date 12/31/2023; P2100054, Exp. Date 12/31/2023; P2100387, Exp. Date 12/31/2023; P2100526, Exp. Date 12/31/2023; P2100525, Exp. Date 12/31/2023; P2100528, Exp. Date 12/31/2023; P2100530, Exp. Date 12/31/2023; P2100532, Exp. Date 12/31/2023; P2100531, Exp. Date 12/31/2023; P2100533, Exp. Date 12/31/2023; P2101127, Exp. Date 1/31/2024; P2101128, Exp. Date 1/31/2024; P2106094, Exp. Date 8/31/2024; P2106091, Exp. Date 8/31/2024; P2106093, Exp. Date 8/31/2024; P2200039, Exp. Date 9/30/2024; P2107771, Exp. Date 11/30/2024; P2107774, Exp. Date 11/30/2024; P2107772, Exp. Date 11/30/2024; P2200505, Exp. Date 12/31/2024; P2200506, Exp. Date 12/31/2024; P2200503, Exp. Date 12/31/2024; P2200510, Exp. Date 12/31/2024; P2200508, Exp. Date12/31/2024; P2203056, Exp. Date 5/31/2025; P2203058, Exp. Date 5/31/2025; P2203060, Exp. Date 5/31/2025; P2203057, Exp. Date 5/31/2025; P2203059, Exp. Date 5/31/2025; P2203584, Exp. Date 6/30/2025; P2205372, Exp. Date 8/31/2025; P2205376, Exp. Date 8/31/2025;

Label field

Details supplied by the agency

Lot, code or applicability

Batches: a) P2002450, Exp. Date 4/30/2023, P2003222, Exp. Date 5/31/2023; P2003223, Exp. Date 5/31/2023; P2003224, Exp. Date 5/31/2023; P2004636, Exp. Date 8/31/2023; P2005035, Exp. Date 8/31/2023; P2005038, Exp. Date 8/31/2023; P2005040, Exp. Date 8/31/2023; P2005039, Exp. Date 8/31/2023; P2005041, Exp. Date 8/31/2023; P2005606, Exp. Date 9/30/2023; P2100340, Exp. Date 9/30/2023; P2100009, Exp. Date 12/31/2023; P2100010, Exp. Date 12/31/2023; P2100044, Exp. Date 12/31/2023; P2100045, Exp. Date 12/31/2023; P2100046, Exp. Date 12/31/2023; P2101129, Exp. Date 1/31/2024; P2101880, Exp. Date 1/31/2024; P2101130, Exp. Date 1/31/2024; P2101131, Exp. Date 1/31/2024; P2106689, Exp. Date 9/30/2024; P2106691, Exp. Date 9/30/2024; P2203585, Exp. Date 6/30/2025; b) P2002451 Exp. Date 4/30/2023; P2005365, Exp. Date 8/31/2023; P2005036, Exp. Date 8/31/2023; P2005037, Exp. Date 8/31/2023; P2005607, Exp. Date 9/30/2023; P2005608, Exp. Date 9/30/2023; P2100048, Exp. Date 12/31/2023; P2100052, Exp. Date 12/31/2023; P2100053, Exp. Date 12/31/2023; P2100055, Exp. Date 12/31/2023; P2100054, Exp. Date 12/31/2023; P2100387, Exp. Date 12/31/2023; P2100526, Exp. Date 12/31/2023; P2100525, Exp. Date 12/31/2023; P2100528, Exp. Date 12/31/2023; P2100530, Exp. Date 12/31/2023; P2100532, Exp. Date 12/31/2023; P2100531, Exp. Date 12/31/2023; P2100533, Exp. Date 12/31/2023; P2101127, Exp. Date 1/31/2024; P2101128, Exp. Date 1/31/2024; P2106094, Exp. Date 8/31/2024; P2106091, Exp. Date 8/31/2024; P2106093, Exp. Date 8/31/2024; P2200039, Exp. Date 9/30/2024; P2107771, Exp. Date 11/30/2024; P2107774, Exp. Date 11/30/2024; P2107772, Exp. Date 11/30/2024; P2200505, Exp. Date 12/31/2024; P2200506, Exp. Date 12/31/2024; P2200503, Exp. Date 12/31/2024; P2200510, Exp. Date 12/31/2024; P2200508, Exp. Date12/31/2024; P2203056, Exp. Date 5/31/2025; P2203058, Exp. Date 5/31/2025; P2203060, Exp. Date 5/31/2025; P2203057, Exp. Date 5/31/2025; P2203059, Exp. Date 5/31/2025; P2203584, Exp. Date 6/30/2025; P2205372, Exp. Date 8/31/2025; P2205376, Exp. Date 8/31/2025;

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

United States including Puerto Rico and Canada

No US distribution state could be established from this record. Check the official notice.

Dates in the source

Report date: Mar 8, 2023
Recall initiation date: Feb 7, 2023
Center classification date: Mar 2, 2023
Termination date: Apr 22, 2024

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.