RemedyRepack Losartan Potassium Tablet Recall: FDA Class II

Why it was recalled

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

Product description

Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.

Lot numbers, UPCs & expiration codes

Lot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022

Where it was sold

Product was distributed to customers in AK and PA.

What to do if you have this product

Compare the lot number and expiration date on your package with the codes above.
Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
If you have symptoms you think are related, contact your doctor. In an emergency call 911.
Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number: D-0788-2022
Classification: Class II
Status: Terminated
Recall initiated: Apr 6, 2022
FDA report date: May 4, 2022
Quantity: 433/30 count blister cards, 33/60 count blister cards
Recall type: Voluntary: Firm initiated
Recalling firm: RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-0788-2022, exactly as published.

Show all FDA fields

City: Indiana
State: PA
Status: Terminated
Country: United States
Event ID: 89968
Address: 625 Kolter Dr Ste 4
Code information: Lot # B1467803-120621, exp. date 06/30/2022 Lot # J0585793-121721, exp. date 12/31/2022
Postal code: 15701-3571
Report date: May 4, 2022
Product type: Drugs
Recall number: D-0788-2022
Classification: Class II
Recalling firm: RemedyRepack Inc.
Product quantity: 433/30 count blister cards, 33/60 count blister cards
Termination date: May 27, 2022
Reason for recall: CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Losartan Potassium 50 mg Tablet, a) 30-count blister card (NDC# 70518-3282-1), b) 60-count blister card (NDC: 70518-3282-0), Rx Only, MFG by: Lupin Pharma, Baltimore, MD 21202.
Distribution pattern: Product was distributed to customers in AK and PA.
Recall initiation date: Apr 6, 2022
Initial firm notification: E-Mail
Center classification date: Apr 26, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0788-2022, published May 4, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

RemedyRepack Losartan Potassium 50 mg Tablet Recall

Summary