CLASS II Drug recall · Reported 4 May 2022 · FDA Enforcement Report
Losartan Potassium, a) blister card recalled by RemedyRepack
RemedyRepack is recalling Losartan Potassium, a) blister card (, distributed in Alaska, Pennsylvania. The recall was initiated on 6 Apr 2022 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-0788-2022
- FDA event ID
- 89968
- Recalling firm
- RemedyRepack, Indiana, PA
- Brand
- Losartan Potassium
- Manufacturer
- REMEDYREPACK INC.
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 6 Apr 2022
- FDA classified
- 26 Apr 2022
- Reported
- 4 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 6 Apr 2022 | Recall initiated by company | |
| 26 Apr 2022 | Classified by FDA | +20 days |
| 4 May 2022 | Published in enforcement report | +8 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- AZIDO Impurity levels observed to be above acceptable limits.
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.
Where it was distributed
Product was distributed to customers in AK and PA.
Questions about this recall
Why was it recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Which lots are affected?
Lot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022
Where was it sold?
Product was distributed to customers in AK and PA.
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 26 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 RemedyRepack
All 61| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Clindamycin HCl Capsule, 300 mg, QTY recalled by RemedyRePack | RemedyRePack | Manufacturing (CGMP) Deviations | FL, PA, VA |
| Drug | CLASS II | Clindamycin HCl, QTY recalled by RemedyRepack | RemedyRepack | Manufacturing (CGMP) Deviations | PA |
| Drug | CLASS II | Carvedilol, QTY: per Blister Pack ( blister cards) recalled | RemedyRepack | Nitrosamine Impurity | FL |
| Drug | CLASS II | Duloxetine Delayed-Release Capsules, 60 mg, a) blister cards recalled | RemedyRepack | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Potassium Chloride Micro 10mEq recalled by RemedyRepack | RemedyRepack | Potency & Assay | Nationwide |
Other Losartan recalls
All 98| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium | Strides Pharma | Foreign Material | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |