CLASS II Drug recall · Reported 27 Mar 2019 · FDA Enforcement Report
Losartan Potassium and Hydrochlorothiazide Tablets recalled by AVKARE
AVKARE is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg Unit Dose, distributed nationwide in the US. The recall was initiated on 5 Mar 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-1046-2019
- FDA event ID
- 82314
- Recalling firm
- AVKARE, Pulaski, TN
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 5 Mar 2019
- FDA classified
- 21 Mar 2019
- Reported
- 27 Mar 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 5 Mar 2019 | Recall initiated by company | |
| 21 Mar 2019 | Classified by FDA | +16 days |
| 27 Mar 2019 | Published in enforcement report | +6 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: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
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 and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tablets (5x10) Unit Dose boxes, Rx Only Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-514-15
Where it was distributed
Nationwide.
Questions about this recall
Is Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg Unit Dose recalled?
Yes. AVKARE recalled Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg Unit Dose on 5 Mar 2019. The recall is Class II and its status is Terminated. Recall number D-1046-2019.
Why was it recalled?
CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified
Which lots are affected?
Lot: 19326 Exp. 03/31/2019
Where was it sold?
Nationwide.
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.
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