Direct Rx Losartan Pot/HCTZ 100/12.5 mg 90 Tabs Recall: AZIDO Impurity Risk
Direct Rx recalls Losartan Pot/HCTZ 100/12.5 mg 90-tab tablets (NDC 72189-290-90) due to AZIDO impurity levels exceeding safety limits. Affected lots manufactured by Macleods Pharma USA, Inc. in Plainsboro, NJ.
Recall notice
CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits .
Contact the company
What happened, in plain English
Direct Rx is recalling Losartan Pot/HCTZ 100/12.5 mg tablets because they contain AZIDO impurities at levels above acceptable safety limits. This could pose a health risk if taken by users. Read more at govinfonow.com/recall/34725-direct-rx-losartan-pot-hctz-100-12-5-mg-90.
Source Summary by GovInfoNow · govinfonow.com/recall/34725-direct-rx-losartan-pot-hctz-100-12-5-mg-90 · Updated August 18, 2026 · FDA enforcement record: FDA #D-0893-2022
Cite this page
“Direct Rx Losartan Pot/HCTZ 100/12.5 mg 90 Tabs Recall: AZIDO Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34725-direct-rx-losartan-pot-hctz-100-12-5-mg-90. Based on FDA recall #D-0893-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0893-2022%22&limit=1).
Why it’s dangerous
The recall is due to AZIDO impurities being detected in the medication at levels that exceed the acceptable safety limits. This could potentially cause health issues if the medication is taken as directed.
Who’s affected
People who purchased or have the Losartan Pot/HCTZ 100/12.5 mg 90-tab tablets (NDC 72189-290-90) from Direct Rx in the U.S. are affected. Those with the specific lot number (25OC2116) produced by Macleods Pharma USA, Inc. are at highest risk.
How to tell if you have this one
Check for the product name 'Losartan Pot/HCTZ 100/12.5 mg 90 Tabs' with NDC code 72189-290-90. The lot number 25OC2116 was produced by Macleods Pharma USA, Inc. in Plainsboro, NJ.
- Brand
Direct Rx- Category
Drug
All 3 products in this recall
FDA lists each product line separately under one recall event. Check your product description, lot or code numbers against each row. Every row shares the hazard and remedy on this page.
- Classification
Class II- Status
Terminated- Distribution
FL
| Recall number | Product, codes & lots | Quantity | NDC |
|---|---|---|---|
| D-0893-2022 | Losartan Pot/HCTZ 100/12.5 mg 90 Tabs NDC 72189-290-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540; Lot: 25OC2116 Exp. 5/31/23 | 11 bottles | 72189-290-90 |
| D-0894-2022 | Losartan Pot/HCTZ 50/12.5 mg 90 Tabs NDC 72189-297-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540; Lots: 19NO2108 Exp. 1/31/25; 19NO2114 Exp. 1/31/25; 22NO2126 Exp. 1/31/25 | 6 bottles | 72189-297-90 |
| D-0895-2022 | Losartan Pot/HCTZ 100/25 mg 90 Tabs NDC 72189-289-90 Packaged and Distributed By: Direct Rx Dawsonville, GA 30534 Mfg. For Macleods Pharma USA, Inc. Plainsboro, NJ 08540; Lots: 08NO2102 Exp. 1/31/25; 17NO2118 Exp. 1/31/25; 18NO2123 Exp. 1/31/25; 25OC2114 Exp. 1/31/25; 22NO2105 Exp. 1/31/25 | 11 bottles | 72189-289-90 |
What to do — step by step
Check Product Details
Verify the product name, NDC code, and lot number to confirm if your medication is affected.
Where it went and when
Where it was distributed
Distributed in Florida.
FDA distribution: “FL” States read from FDA’s own wording; “not listed” means the notice does not name it.
States: Florida.
Recall timeline
FDA terminated this recall 7 months after the firm started it.
- Firm started the recall
- FDA classified it Class II
- Published in FDA’s Enforcement Report
- FDA terminated the recall
Dates from the agency record only; steps without a date are left out.
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Where this comes from
The facts (hazard, remedy, dates, manufacturer) are pulled from the official FDA recall record. The plain-language summary and step-by-step checklist are written by GovInfoNow to make the official notice easier to act on — they don’t replace it.
- Official source: FDA Recall #D-0893-2022 (May 11, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0893-2022 to see it in context.
- Plain-language summary written by qwen3:4b on August 18, 2026, from the official record above. Not reviewed by a person — if it conflicts with the FDA notice, the notice is correct. Report an error on this page.
- GovInfoNow is an independent service and is not a government agency. We republish official FDA recall data; we don’t issue, amend or administer recalls.