CLASS II Drug recall · Reported 1 Jun 2022 · FDA Enforcement Report
Losartan HCTZ 100/12.5 mg recalled by RemedyRepack
RemedyRepack is recalling Losartan HCTZ 100/12.5 mg, distributed in Florida, South Carolina, Virginia. The recall was initiated on 2 May 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-0887-2022
- FDA event ID
- 90127
- Recalling firm
- RemedyRepack, Indiana, PA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 2 May 2022
- FDA classified
- 20 May 2022
- Reported
- 1 Jun 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 2 May 2022 | Recall initiated by company | |
| 20 May 2022 | Classified by FDA | +18 days |
| 1 Jun 2022 | Published in enforcement report | +12 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 HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09
Where it was distributed
Product was distributed to FL, SC and VA
Questions about this recall
Why was it recalled?
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Which lots are affected?
Lot # B1364261-092721, exp. date 09/30/2022 B1377667-100521, exp. date 10/31/2022 B1412576-102621, exp. date 10/31/2022 B1436925-111321, exp. date 11/30/2022
Where was it sold?
Product was distributed to FL, SC and VA
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.
Other products in this recall event
1 other product · FDA event 90127This product is part of a recall event; the main page for the event is Losartan HCTZ 100/25 mg recalled by RemedyRepack.
| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| CLASS II | Losartan HCTZ 100/25 mg recalled by RemedyRepack | RemedyRepack | Potency & Assay | FL, SC, VA |
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 Hctz 100 recalls
All 2| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Losartan HCTZ 100/25 mg recalled by RemedyRepack | RemedyRepack | Potency & Assay | FL, SC, VA |