RemedyRepack Amlodipine/Valsartan/HCTZ Tablet Recall (Class II)

Why it was recalled

CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.

Product description

Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0

Lot numbers, UPCs & expiration codes

70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019

Where it was sold

South Carolina

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-1146-2018
Classification: Class II
Status: Terminated
Recall initiated: Aug 20, 2018
FDA report date: Sep 5, 2018
Quantity: 3 bottles of 90 tablets (270 tablets overall)
Recall type: Voluntary: Firm initiated
Recalling firm: RemedyRepack Inc.

Original FDA data

Every field from FDA enforcement report D-1146-2018, exactly as published.

Show all FDA fields

City: Indiana
State: PA
Status: Terminated
Country: United States
Event ID: 80891
Address: 625 Kolter Dr Ste 4
Code information: 70518-1220-0; Lot #: B0476653-080218; Exp. Date: 08/2019
Postal code: 15701-3571
Report date: Sep 5, 2018
Product type: Drugs
Recall number: D-1146-2018
Classification: Class II
Recalling firm: RemedyRepack Inc.
Product quantity: 3 bottles of 90 tablets (270 tablets overall)
Termination date: Oct 10, 2018
Reason for recall: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Voluntary / mandated: Voluntary: Firm initiated
Product description: Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Tablet, Rx Only (HDPE 90cc Bottles in cardboard trays) MFG Torrent Pharma LTD, Indrad, India 38272, NDC #70518-1220-0
Distribution pattern: South Carolina
Recall initiation date: Aug 20, 2018
Initial firm notification: E-Mail
Center classification date: Aug 28, 2018

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-1146-2018, published Sep 5, 2018. 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 Amlodipine/Valsartan/HCTZ 10mg/320mg/25mg Recall

Summary