CLASS II Drug recall · Reported 8 Jun 2022 · FDA Enforcement Report

Losartan Pot./HCTZ 100/12.5 mg Packaged recalled by Direct Rx

Direct Rx is recalling Losartan Pot./HCTZ 100/12.5 mg Packaged, distributed in Alabama, Florida, Georgia, Louisiana. The recall was initiated on 5 May 2022 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesa) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22

NDC72189-012, 72189-098, 72189-129, 72189-139, 72189-167

Quantity recalled81 bottles

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-0971-2022
FDA event ID: 90161
Recalling firm: Direct Rx, Dawsonville, GA
Brand: Losartan Potassium And Hydrochlorothiazide
Manufacturer: Direct_Rx
Classification: Class II
Status: Terminated
Recall initiated: 5 May 2022
FDA classified: 27 May 2022
Reported: 8 Jun 2022
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Potency & Assay
Drug class: Blood Pressure Medication

Timeline

5 May 2022	Recall initiated by company
27 May 2022	Classified by FDA	+22 days
8 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 Pot./HCTZ 100/12.5 mg Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg For: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202 a) 30 Tabs NDC 72189-167-30; b) 90 Tabs NDC 72189-167-90

Where it was distributed

AL, GA, FL, LA

Alabama Florida Georgia Louisiana

Questions about this recall

Why was it recalled?

CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits

Which lots are affected?

a) 30-count bottles- Lot: 11MY2103 Exp. 11/30/22 Lot: 05JA2106 Exp. 6/30/22 b) 90-count bottles- Lot: 20MY2115 Exp. 11/30/22 Lot: 22JU2118 Exp. 12/31/22 Lot: 29JY2113 Exp. 12/31/22 Lot: 13SE2113 Exp. 2/28/23 Lot: 05JA2106 Exp. 6/30/22

Where was it sold?

AL, GA, FL, LA

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 Direct Rx

All 37

Reported	Class	Recall	Company	Reason	Where
1 Jul 2026Drug	CLASS II	Duloxetine D/R, a) 30 mg recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 30 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
13 Aug 2025Drug	CLASS II	Duloxetine D/R, 20 mg, 30 Caps recalled by Direct Rx	Direct Rx	Nitrosamine Impurity	Nationwide
23 Apr 2025Drug	CLASS II	Ciprofloxacin Ophth Solution recalled by Direct Rx	Direct Rx	Packaging Defects	5 states
13 Nov 2024Drug	CLASS II	Ibuprofen 800mg, Generic for: Motrin, Each tablet contains recalled	Direct Rx	Potency & Assay	Nationwide

Other Losartan recalls

All 97

Reported	Class	Recall	Company	Reason	Where
22 May 2024Drug	CLASS II	Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma USA	Foreign Material	Nationwide
12 Jul 2023Drug	CLASS II	Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium	Strides Pharma	Foreign Material	Nationwide
6 Jul 2022Drug	CLASS II	Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide	Macleods Pharma Usa	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide
6 Jul 2022Drug	CLASS II	Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium	PD-Rx Pharmaceuticals	Potency & Assay	Nationwide