Wells Pharma of Houston LLC

FDA Regulatory Profile

Summary

Total Recalls
8
510(k) Clearances
0
Inspections
3
Compliance Actions
1

Recent Recalls

NumberClassProductDate
D-0507-2026Class IIKetamine Hydrochloride Injectable Solution, 50mg/ml, (50 mg per mL) Volume: 1 mL, 5265 Kitty Drive, April 1, 2026
D-0508-2026Class IIfentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 50 mcg/5mL)(10 mcg per mL), wells pharApril 1, 2026
D-0504-2026Class IIfentaNYL Citrate injectable Solution in 0.9% Sodium Chloride, Narcotic, (2500 mcg/ 250 mL) (10 mcg pApril 1, 2026
D-0505-2026Class IIfentaNYL Citrate Injectable Solution, Narcotic, CII, 1250 mcg/25mL (50 mcg per mL), 25 mL, wells phaApril 1, 2026
D-0503-2026Class IIfentaNYL Citrate Injectable Solution, NARCOTIC, Cii, 1000 mcg/100 mL (10 mcg per mL), 100 mL bag, WeApril 1, 2026
D-0506-2026Class IIfentaNYL Citrate Injectable Solution in 0.9% Sodium Chloride, 1000 mcg/50mL (20 mcg per mL), well phApril 1, 2026
D-0502-2026Class IIPhenylephrine Hydrochloride Injectable Solution, 40mg, 250*mL Bag, wells pharma of Houston, NDC 7370April 1, 2026
D-0141-2024Class IIceFAZolin sodium in Sterile Water for injection, Injectable Solution, 1g/10mL (0.1 g per mL), SyringNovember 22, 2023