Losartan Pot/HCTZ 50/12.5 mg Recalled Due to Impurity Detection
Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets distributed in Florida due to trace amounts of impurity NMBA.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The agency classification is FDA Class II, and the rubric specifies that FDA Class II recalls with significant injury reports or structural defects are Severe; while no injuries are explicitly reported, the presence of a nitrosamine impurity in a Class II drug recall aligns with the higher severity tier for significant potential harm.
Plain-English summary
Direct Rx is recalling 33 bottles of Losartan Pot/HCTZ 50/12.5 mg tablets, 90-count, packaged and distributed by Direct Rx in Dawsonville, GA, and manufactured for Torrent Pharma, Inc. in Basking Ridge, NJ. The specific lot number is 12DE1806 with an expiration date of 01/31/2021. The product was distributed in Florida.
The recall was initiated due to a Current Good Manufacturing Practice (CGMP) deviation where trace amounts of the impurity N-Methylnitrosobutyric acid (NMBA) were detected in the active pharmaceutical ingredient (API).
Consumers who have this specific product should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Losartan Pot/HCTZ 50/12.5 mg 90 Tabs Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Torrent Pharma, Inc. Basking Ridge, NJ 07920 NDC 61919-040-90
- Manufacturer
- Direct Rx
- Category
- Drug — Prescription Medication
- Hazard
- Affected units
- 33
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (1)
- Lot: 12DE1806 Exp. 01/31/2021
Distribution
Distributed in 1 state:
Related recalls
Same manufacturer · Direct Rx
See all →- ModerateDuloxetine 30 mg capsules recalled for impurity above FDA limits
FDA (Drugs) · 2026-07-01
- HighDuloxetine delayed-release capsules exceed the interim nitrosamine impurity limit
FDA (Drugs) · 2025-08-13
- HighDirect Rx duloxetine 30 mg capsules exceed the interim nitrosamine limit
FDA (Drugs) · 2025-08-13
- ModerateCiprofloxacin Ophthalmic Solution Recalled for Defective Container Cap
FDA (Drugs) · 2025-04-23
- HighGeneric Ibuprofen 800mg Recalled Due to Failed Impurity and Degradation Specifications
FDA (Drugs) · 2024-11-13
Same hazard · impurity
See all →- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 30mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17