Use caution Drug recall · FDA · Published May 5, 2022

Direct Rx Losartan/HCTZ Recall: Azido Impurity

Direct Rx recalls specific lots of Losartan Pot./HCTZ 100/12.5 mg tablets due to azido impurity levels exceeding acceptable limits.

Plain-English summary generated from official FDA data by GovInfoNow · Published by Carlos Caban · How we make summaries

🇺🇸 FDA recall #D-0971-2022Drug Direct Rx ›

Use caution until it’s fixed

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

Take action

Contact the company

Recalling firmDirect Rx94 Worldwide Dr · Dawsonville, GA 30534-6828

✎ GovInfoNow plain-language explainer

Direct Rx is recalling specific lots of Losartan Potassium/Hydrochlorothiazide 100/12.5 mg tablets because testing showed azido impurity levels above acceptable limits. The recall affects 81 bottles distributed in Alabama, Georgia, Florida, and Louisiana. No specific remedy or return instructions are provided in the record. Read more at govinfonow.com/recall/34793-direct-rx-losartan-hctz-recall-azido-impurity.

Source Summary by GovInfoNow · govinfonow.com/recall/34793-direct-rx-losartan-hctz-recall-azido-impurity · Updated October 10, 2026 · FDA enforcement record: FDA #D-0971-2022

Cite this page

“Direct Rx Losartan/HCTZ Recall: Azido Impurity.” GovInfoNow, updated October 10, 2026. https://govinfonow.com/recall/34793-direct-rx-losartan-hctz-recall-azido-impurity. Based on FDA recall #D-0971-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0971-2022%22&limit=1).

The FDA announced on May 5, 2022, that Direct Rx recalled Losartan Pot./HCTZ Tablets due to azido impurity levels exceeding acceptable limits, according to GovInfoNow's records. The recall affects 81 bottles distributed in Alabama, Georgia, Florida, and Louisiana.

How to tell if you have it

Brand: Direct Rx
Product: Losartan Pot./HCTZ Tablets
Strength: 100/12.5 mg
NDC 72189-167-30 (30-count bottles, Lots 11MY2103 Exp. 11/30/22; 05JA2106 Exp. 6/30/22)
NDC 72189-167-90 (90-count bottles, Lots 20MY2115 Exp. 11/30/22; 22JU2118 Exp. 12/31/22; 29JY2113 Exp. 12/31/22; 13SE2113 Exp. 2/28/23; 05JA2106 Exp. 6/30/22)

The hazard

The recall stems from CGMP deviations where azido impurity levels were observed to be above acceptable limits, according to the FDA.

Context

GovInfoNow's records show Direct Rx has had 19 other recalls since March 12, 2019. Recent similar recalls include a June 22, 2026 recall of DULOXETINE D/R 30mg Capsules for N-nitroso-duloxetine impurity risk and a March 7, 2025 recall of Duloxetine 30mg Capsules for nitrosamine impurity risk. Other recent recalls of similar products include an Jan. 21, 2026 recall of Unichem Bisoprolol/Hydrochlorothiazide Tablets for N-Nitroso Impurity Risk and a July 13, 2026 recall of Major Pharmaceuticals Levothyroxine Tablets for Subpotent Drug Risk.

How to tell if you have this one

Check your bottle for NDC 72189-167-30 (30 Tabs) or NDC 72189-167-90 (90 Tabs). Verify if the lot number is one of: 11MY2103, 05JA2106, 20MY2115, 22JU2118, 29JY2113, or 13SE2113. Confirm the expiration date matches the lot (e.g., Exp. 11/30/22 for lot 11MY2103).

Brand
Direct Rx
Category
Drug

Based on the official FDA remedy

What to do — step by step

Check Your Medication
Verify if your bottle matches the recalled NDC numbers and lot codes listed in the record.
Contact Your Pharmacist
Speak with your pharmacist or healthcare provider to determine the appropriate next steps for your specific prescription.

Where it went and when

Where it was distributed

Distributed in 4 states.

FDA distribution: “AL, GA, FL, LA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Alabama, Florida, Georgia, Louisiana.

Recall timeline

FDA terminated this recall 17 months after the firm started it.

May 5, 2022Firm started the recall
May 27, 2022FDA classified it Class II
Jun 8, 2022Published in FDA’s Enforcement Report
Oct 5, 2023FDA terminated the recall

Dates from the agency record only; steps without a date are left out.

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Other Direct Rx recalls

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Keep exploring

Link to this recall

<a href="https://govinfonow.com/recall/34793-direct-rx-losartan-hctz-recall-azido-impurity">Direct Rx Losartan/HCTZ Recall: Azido Impurity (GovInfoNow)</a>

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-0971-2022 (May 5, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0971-2022 to see it in context.
Plain-language summary written by qwen3.6:35b-a3b on October 10, 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.