RecallRadar

FDA Drug recall D-0414-2023

Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7

On 2023-03-08 the FDA classified a Class II recall of Tadalafil Tablets, USP, 2.5 mg Rx Only, Packaged as: a) 30-count bottle NDC 16729-369-10, UPC 3 16729 36910 7 by Accord Healthcare, citing CGMP Deviations: recalling drug products following an FDA inspection.

Read the official FDA Drug notice

AgencyFDA Drug
Recall numberD-0414-2023
ClassificationClass II
Statusterminated
Initiated2023-02-07
Published2023-03-08
Last updated2026-09-13 11:52 UTC
CompanyAccord Healthcare
DistributionPR

Product

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-count bottle NDC 16729-369-16, UPC 3 16729 36916 9; 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.

Identifiers

upc316729369107
upc316729369169
ndc16729-370-10
ndc16729-370-15
ndc16729-370-16
ndc16729-370-17
ndc16729-370-97
ndc16729-369-10
ndc16729-369-15
ndc16729-369-16
ndc16729-369-17
ndc16729-369-97
ndc16729-371-10
ndc16729-371-15
ndc16729-371-16
ndc16729-371-17
ndc16729-372-10
ndc16729-372-15
ndc16729-372-16
ndc16729-372-17
code_info
Batches: a) P2002522, Exp. Date 4/30/2023; P2005817, P2005816, Exp. Date 10/31/2023; P2203687, Exp. Date 6/30/2025; b)…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;

Status history

No status changes recorded since RecallRadar first saw this recall on 2026-09-13 11:52 UTC. Current status: terminated.

Source

Official record: https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0414-2023%22

RecallRadar indexes public recall notices from the FDA, USDA FSIS, and CPSC. The official agency notice is the authoritative source. Always confirm details at the linked source before acting.