Class II · Moderate risk
Losartan Potassium and Hydrochlorothiazide Tablets
Presence of foreign substance: plastic-like substance.
Losartan Potassium USP
Class II — Moderate risk. May cause temporary or reversible harm; serious harm unlikely.
Why it was recalled
CGMP deviation: Product found to contain trace amounts of NMBA
Cause type: Nitrosamine impurity
Trace nitrosamine impurities such as NDMA, NDEA or NMBA found above the acceptable daily limit. Nitrosamines are probable human carcinogens that can form during manufacturing or storage. This is the cause behind the large valsartan, losartan and ranitidine (Zantac) recalls. All nitrosamine impurity recalls.
What was recalled
Losartan Potassium USP, 50 mg, RX Only, Pkg By PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127 a) 60 Tablets NDC: 43063-854-60; b) 90 Tablets NDC: 43063-0854-90
Affected NDCs
43063-0854-60
43063-0854-90
Compare with the code on your package — it is the most precise check available.
Drug: Losartan Category: Blood Pressure Medication
Product details
From the FDA NDC directory, for the product code this recall names. Compare with the label on your package.
| Product | Strength | Form & route | Labeler | Type |
|---|---|---|---|---|
| Losartan Potassium NDC 43063-0854 |
50 mg/1 | Tablet, Film Coated Oral |
PD-Rx Pharmaceuticals, Inc. | Rx |
- Recalling firm
- PD-Rx Pharmaceuticals, Inc.
- Origin
- OK, United States
- Initiated by
- Voluntary: Firm initiated
- FDA recall number
- D-0341-2021 · FDA notice
Check, then ask. Class II means harm is possible but usually temporary or reversible. Find the lot number on your package; if it matches, ask your pharmacist about a replacement. Do not simply stop a prescribed medication on your own - the gap can be riskier than the recall. This recall is now terminated, which means the firm has finished removing the affected product; anything on pharmacy shelves today should be unaffected.
Other Losartan recalls
See all
Class II · Moderate risk
Losartan Potassium Tablets
Presence of Foreign Substance: Presence of a small piece of blue plastic embedded in the tablet.
Class II · Moderate risk
Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Class II · Moderate risk
Losartan Potassium Tablets
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits
Other recalls by PD-Rx Pharmaceuticals, Inc.
All 2019 recalls
Class II · Moderate risk
DULoxetine DR USP
CGMP Deviations: the presence of a Nitrosamine Drug Substance Related Impurity (NDSRI), N-Nitroso-Duloxetine above the interim acceptable intake limit
Class II · Moderate risk
Simvastatin USP 40 mg
CGMP deviations.
Class II · Moderate risk
Simvastatin USP 20 mg
CGMP deviations.
Class II · Moderate risk
Glimepiride USP
CGMP deviations.
Free recall alerts
Know the day your medication is recalled
Tell us what you take. When FDA posts a recall announcement or classifies a recall for one of your medications, we email you in plain English, with what to check. No account needed.