Torrent Pharma Inc. FDA Recalls

5 recalls on file across drugs, 0 of them Class I and 0 still open. This firm is not matched to a listed company.

Newest first

Class I is the FDA's most serious grade: a reasonable probability of serious harm or death.

Product	Reason	Class	Initiated
Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-38Class IIMay 27, 2025CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding	CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.	Class IIDrugs	May 27, 2025
Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: TORRENT PHARMACEUTIALS LTD., Indrad-382 721 Class IIMay 27, 2025CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding	CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit.	Class IIDrugs	May 27, 2025
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent PharmaClass IIApr 11, 2022CGMP deviations: tablets cracking	CGMP deviations: tablets cracking	Class IIDrugs	Apr 11, 2022
Carbamazepine Tablets, USP 200 mg 100 Tablets Rx only NDC 13668-268-01 Manufactured by: Torrent Pharmaceuticals Ltd. BhaClass IIDec 2, 2021Failed Dissolution Specifications	Failed Dissolution Specifications	Class IIDrugs	Dec 2, 2021
Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent PhClass IIIDec 1, 2021Superpotent; Hydrochlorothiazide	Superpotent; Hydrochlorothiazide	Class IIIDrugs	Dec 1, 2021