FDA drug recalls · openFDA
Is TADALAFIL recalled?
The FDA has recorded 7 recalls of TADALAFIL (2023) , recalled under brand like TADALAFIL. 3 still ongoing.
0
Class I (most serious)
7
Class II
0
Class III
3
ongoing
A recall doesn't mean your pills are affected
Drug recalls are issued by lot (specific batches, identified by lot numbers / NDC) — not for every bottle of TADALAFIL ever made. To know if yours is involved, match the lot codes on the recall below against your bottle, or ask your pharmacist. Do not stop a prescribed medication because of a recall without talking to your pharmacist or prescriber — stopping can be more dangerous than the recall. The Class is the FDA's risk judgment (Class I = reasonable probability of serious harm or death), not a measurement that harm occurred; most recalls are voluntary and Class II/III.
Why it was recalled
CGMP Deviations: recalling drug products following an FDA inspection. 4
CGMP Deviations 2
cGMP Deviations for the manufacturing Firm (Accord Healthcare) after their inspection. 1
The recalls
Class I and ongoing recalls first. Tap a recall for its full record and lot detail.
Tadalafil Tablets, USP, 20 mg, 7-count bottle, Rx only, Manufactured for: Accord Healthcare, lnc., Durham, NC 27703, NDC Class II ongoing
Preferred Pharmaceuticals, Inc. 2023-03-23 lots: Lot: C0822E, Exp 1/31/2024, F1121B, Exp 1/31/2024, G2721L, Exp 1/31/2024.
Tadalafil Tablets, USP 10 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-371-10, UPC 3 16729 37110 0; b) 500-co Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2002525, Exp. Date 4/30/2023; P2004442, Exp. Date 7/31/2023; P2005014, Exp. Date 8/31/2023; P2005015, Exp. Date 8/31/2023; P2005016, Exp. Date 8/31/2023; P2005825, Exp. Date 10/31/2023; P2005824, Exp. Date 10/31/2023; P2005826, Exp. Date 10/31/2023; P2100368, Exp. Date 12/31/2023; P2100444, Exp. Date 12/31/2023; P2101262, Exp. Date 2/29/2024; P2101263, Exp. Date 2/29/2024; P2200813, Exp. Date 1/31/2025; P2200814, Exp. Date 1/31/2025; b) P2002526, Exp. Date 4/30/2023; P2003781, Exp. Date 6/30/2023; P2003782, Exp. Date 6/30/2023; P2003783, Exp. Date 6/30/2023; P2004440, Exp. Date 7/31/2023; P2004441, Exp. Date 7/31/2023; P2005820, Exp. Date 10/31/2023; P2005821, Exp. Date 10/31/2023; P2005823, Exp. Date 10/31/2023; P2100077, Exp. Date 12/31/2023; P2100076, Exp. Date 12/31/2023; P2100078, Exp. Date 12/31/2023; P2100079, Exp. Date 12/31/2023; P2100080, Exp. Date 12/31/2023; P2100366, Exp. Date 12/31/2023; P2100442, Exp. Date 12/31/2023; P2100443, Exp. Date 12/31/2023; P2101265, Exp. Date 2/29/2024; P2101264, Exp. Date 2/29/2024; P2101718, Exp. Date 2/29/2024; P2108091, Exp. Date 11/30/2024; P2108092, Exp. Date 11/30/2024; P2108093, Exp. Date 11/30/2024; P2203589, Exp. Date 6/30/2025; P2203588, Exp. Date 6/30/2025; P2205379, Exp. Date 8/31/2025;
Tadalafil Tablets, USP 20 mg, packaged in a) 6-count bottles (NDC 51655-473-87), and b) 15-count bottles (NDC 51655-473- Class II ongoing
Northwind Pharmaceuticals LLC 2023-03-16 lots: a) Lot #: F113892002, Exp. Date 08/31/2023; F113892201, Exp. Date 11/30/2023 b) Lot #: F113892001, Exp. Date 08/31/2023; F113892202, Exp. Date 11/30/2023; F113892203, Exp. Date 12/31/2023
Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7; b) 500-c Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b) P2002521, Exp. Date 4/30/2023; P2005818, Exp. Date 10/31/2023; P2100075, Exp. Date 12/31/2023; P2100996, P2100997, P2100998, P2100999, Exp. Date 1/31/2024;
Tadalafil Tablets, USP, 20 mg, Rx Only, Packaged as: a) 30-count bottle NDC 16729-372-10, UPC 3 16729 37210 7; b) 500-c Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: Batches: a) P2002461, Exp. Date 4/30/2023; P2002457, Exp. Date 4/30/2023; P2002460, Exp. Date 4/30/2023; P2002464, Exp. Date 4/30/2023; P2002463, Exp. Date 4/30/2023; P2002462, Exp. Date 4/30/2023; P2002465, Exp. Date 4/30/2023; P2003153, Exp. Date 5/31/2023; P2003155, Exp. Date 5/31/2023; P2003156, Exp. Date 5/31/2023; P2003154, Exp. Date 5/31/2023; P2003152, Exp. Date 5/31/2023; P2003157, Exp. Date 5/31/2023; P2003158, Exp. Date 5/31/2023; P2003159, Exp. Date 5/31/2023; P2003162, Exp. Date 5/31/2023; P2003160, Exp. Date 5/31/2023; P2003778, Exp. Date 6/30/2023; P2003779, Exp. Date 6/30/2023; P2004315, Exp. Date 6/30/2023; P2004818, Exp. Date 8/31/2023; P2004819, Exp. Date 8/31/2023; P2005158, Exp. Date 8/31/2023; P2005156, Exp. Date 8/31/2023; P2005157, Exp. Date 8/31/2023; P2005247, Exp. Date 9/30/2023; P2006641, Exp. Date 11/30/2023; P2101002, Exp. Date 1/31/2024; P2101004, Exp. Date 1/31/2024; P2101003, Exp. Date 1/31/2024; P2101006, Exp. Date 1/31/2024; P2101005, Exp. Date 1/31/2024; P2101008, Exp. Date 1/31/2024; P2101023, Exp. Date 1/31/2024; P2101022, Exp. Date 1/31/2024; P2101274, Exp. Date 2/29/2024; P2202085, Exp. Date 3/31/2025; b) P2002467, Exp. Date 4/30/2023; P2002466, Exp. Date 4/30/2023; P2002468, Exp. Date 4/30/2023; P2003780, Exp. Date 6/30/2023; P2005154, Exp. Date 8/31/2023; P2005244, Exp. Date 9/30/2023; P2005246, Exp. Date 9/30/2023; P2005809, Exp. Date 10/31/2023; P2005810, Exp. Date 10/31/2023; P2006642, Exp. Date 11/30/2023; P2006643, Exp. Date 11/30/2023; P2006644, Exp. Date 11/30/2023; P2006645, Exp. Date 11/30/2023; P2006646, Exp. Date 11/30/2023; P2006647, Exp. Date 11/30/2023; P2100463, Exp. Date 12/31/2023; P2100462, Exp. Date 12/31/2023; P2100464, Exp. Date 12/31/2023; P2100465, Exp. Date 12/31/2023; P2100498, Exp. Date 12/31/2023; P2100497, Exp. Date 12/31/2023; P2100499, Exp. Date 12/31/2023; P2100573 ,Exp. Date 1/31/2024; P2100572, Exp. Date 1/31/2024; P2100574, Exp. Date 1/31/2024; P2101007, Exp. Date 1/31/2024; P2202084, Exp. Date 3/31/2025;
Tadalafil Tablets, USP, 5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-370-10, UPC 3 16729 37010 3; b) 500-coun Class II Terminated
Accord Healthcare, Inc. 2023-02-07 lots: 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;
Tadalafil Tablets, USP 5 mg, 30-count bottles, Rx Only, Repackaged By: Northwind Pharmaceuticals, Indianapolis, IN 46203 Class II ongoing
Northwind Pharmaceuticals LLC 2023-03-16 lots: Lot #: F114302001, Exp. Date 05/31/2023
RECORDED — these are the FDA's published recall enforcement records (openFDA), grouped by the generic drug name. Scope: drug recalls the FDA recorded with a generic name; device recalls and recalls without a generic name are in the full recall browse. "Ongoing" reflects openFDA's last-published status — confirm current status and your lot at the FDA recall database. This page informs and routes; it is not medical advice.