CLASS II Drug recall · Reported 14 Oct 2020 · FDA Enforcement Report
Losartan Potassium 100 mg, 30 Tabs recalled by Direct Rx
Direct Rx is recalling Losartan Potassium 100 mg, 30 Tabs, distributed in Georgia. The recall was initiated on 30 Apr 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0018-2021
- FDA event ID
- 86499
- Recalling firm
- Direct Rx, Dawsonville, GA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 30 Apr 2019
- FDA classified
- 5 Oct 2020
- Reported
- 14 Oct 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 30 Apr 2019 | Recall initiated by company | |
| 5 Oct 2020 | Classified by FDA | +524 days |
| 14 Oct 2020 | Published in enforcement report | +9 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Losartan Potassium 100 mg, 30 Tabs bottles, Rx only, Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 NDC 61919-952-30
Where it was distributed
GA
Questions about this recall
Is Losartan Potassium 100 mg, 30 Tabs recalled?
Yes. Direct Rx recalled Losartan Potassium 100 mg, 30 Tabs on 30 Apr 2019. The recall is Class II and its status is Terminated. Recall number D-0018-2021.
Why was it recalled?
CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in the finished product above the interim acceptable daily intake level per manufacturer
Which lots are affected?
Lot: 27AU1801 Exp. 02/28/2021
Where was it sold?
GA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from Direct Rx
All 37| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Duloxetine D/R, a) 30 mg recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ciprofloxacin Ophth Solution recalled by Direct Rx | Direct Rx | Packaging Defects | 5 states |
| Drug | CLASS II | Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled | Direct Rx | Potency & Assay | Nationwide |