Unrated Drug recall · FDA · Published May 2, 2022

RemedyRePack Losartan HCTZ 100/25 mg Recall: AZIDO Impurity Risk

RemedyRePack recalls Losartan HCTZ 100/25 mg tablets due to AZIDO impurity levels above safety limits. Affected lots expired by 10/31/2022.

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

🇺🇸 FDA recall #D-0886-2022Drug RemedyRePack ›

Recall notice

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

Take action

Contact the company

Recalling firmRemedyRepack Inc.625 Kolter Dr Ste 4 · Indiana, PA 15701-3571

✎ GovInfoNow plain-language explainer

RemedyRePack is recalling Losartan HCTZ 100/25 mg tablets that were repackaged from the original NDC 68180-0217-09. The recall is due to AZIDO impurity levels exceeding acceptable safety limits, which could pose a health risk. Read more at govinfonow.com/recall/34800-remedyrepack-losartan-hctz-100-25-mg-recall-azido-impurity-risk.

Source Summary by GovInfoNow · govinfonow.com/recall/34800-remedyrepack-losartan-hctz-100-25-mg-recall-azido-impurity-risk · Updated August 18, 2026 · FDA enforcement record: FDA #D-0886-2022

Cite this page

“RemedyRePack Losartan HCTZ 100/25 mg Recall: AZIDO Impurity Risk.” GovInfoNow, updated August 18, 2026. https://govinfonow.com/recall/34800-remedyrepack-losartan-hctz-100-25-mg-recall-azido-impurity-risk. Based on FDA recall #D-0886-2022 (https://api.fda.gov/drug/enforcement.json?search=recall_number:%22D-0886-2022%22&limit=1).

The FDA announced on May 2, 2022, that RemedyRepack Inc. voluntarily recalled Losartan HCTZ 100/25 mg bottles due to azido impurity levels exceeding acceptable limits. Owners should contact the company for a refund.

How to tell if you have it

Brand: RemedyRePack
Product: Losartan HCTZ 100/25 mg, 90 count bottles
NDC# 70518-2578-00
Original NDC # 68180-0217-09
Lot codes: B1329507-082921, B1348363-091421, B1387286-101021, B1390974-101221, B1426010-110521
Expiration dates: 08/31/2022, 09/30/2022, 10/31/2022, 11/30/2022
Distribution: FL, SC and VA

The hazard

The recall addresses CGMP deviations where azido impurity levels were observed to be above acceptable limits.

Context

GovInfoNow's records show RemedyRePack Inc. has 35 other recalls on record since 2015-02-18. Recent brand recalls include Clindamycin Capsules recalled on 2025-04-22 and 2025-03-24 due to CGMP deviations, as well as Carvedilol Tablets recalled on 2025-01-24 for N-Nitroso impurity risk. Other recent recalls of similar products include Zydus Mirabegron 25mg Tablets (2026-08-05), Unichem Bisoprolol/Hydrochlorothiazide Tablets (2026-01-21), and Asclemed Duloxetine Capsules (2026-05-14).

How to tell if you have this one

Check for the repackaged NDC 70518-2578-00 on the bottle. The affected lots include B1329507-082921 (exp. 08/31/2022), B1348363-091421 (exp. 09/30/2022), B1387286-101021 (exp. 10/31/2022), B1390974-101221 (exp. 10/31/2022), and B1426010-110521 (exp. 11/30/2022).

Brand
RemedyRePack
Category
Drug

FDA recall event · 2 products

All 2 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
Product was distributed to FL, SC and VA

Recall number	Product, codes & lots	Quantity
D-0886-2022	Losartan HCTZ 100/25 mg, 90 count bottles NDC# 70518-2578-00 Repackaged NDC Original NDC # 68180-0217-09; Lot # B1329507-082921, exp. date 08/31/2022 B1348363-091421, exp. date 09/30/2022 B1387286-101021, exp. date 10/31/2022 B1390974-101221, exp. date 10/31/2022 B1426010-110521, exp. date 11/30/2022	26/90 count bottles = 2,340 tablets
D-0887-2022	Losartan HCTZ 100/12.5 mg, 90 count bottles NDC# 70518-2564-00 Repackaged NDC Original NDC # 68180-0216-09; 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	30 bottles/90 count = 2,700 tablets

Based on the official FDA remedy

What to do — step by step

Check Product Details
Look for the repackaged NDC 70518-2578-00 on the bottle label and check the lot numbers listed in the recall notice.

Where it went and when

Where it was distributed

Distributed in 3 states.

FDA distribution: “Product was distributed to FL, SC and VA” States read from FDA’s own wording; “not listed” means the notice does not name it.

States: Florida, South Carolina, Virginia.

Recall timeline

FDA terminated this recall 4 months after the firm started it.

May 2, 2022Firm started the recall
May 20, 2022FDA classified it Class II
Jun 1, 2022Published in FDA’s Enforcement Report
Sep 2, 2022FDA terminated the recall

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

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Link to this recall

<a href="https://govinfonow.com/recall/34800-remedyrepack-losartan-hctz-100-25-mg-recall-azido-impurity-risk">RemedyRePack Losartan HCTZ 100/25 mg Recall: AZIDO Impurity Risk (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-0886-2022 (May 2, 2022) — FDA publishes no per-recall page; this is the official machine-readable enforcement record. Search FDA recalls for D-0886-2022 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.