The Recall Desk
Agency classClass IIOur severity:HighFDA (Drugs)·D-0789-2022·Announced 2022-05-04

Losartan Potassium Tablets Recalled for AZIDO Impurity Above Limits

Preferred Pharmaceuticals is recalling Losartan Potassium 50mg tablets due to AZIDO impurity levels exceeding acceptable limits. The affected product was distributed to California, Indiana, and Florida.

The agency’s classification

FDA (Drugs): Class II

Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.

This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work

What this means for you

Our assessment, not the agency’s: severity 3/5 (High).

Real risk of harm even if no illness or injury has been reported yet. Stop using the product and follow the agency's guidance.

Our severity reasoning: FDA Class II pharmaceutical recall for CGMP deviation with AZIDO impurity levels exceeding acceptable limits. No illnesses or injuries have been reported, making this a potential risk-of-harm product without yet-documented harm, consistent with the High severity threshold.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling certain batches of Losartan Potassium Tablet USP 50mg due to a current good manufacturing practice (CGMP) deviation involving elevated AZIDO impurity levels. The affected product was distributed nationwide to California, Indiana, and Florida.

The recalled lots are E1321O, E2521H, and E2621F, all expiring May 31, 2023. The total quantity includes 44 bottles containing 90 tablets each and 33 bottles containing 30 tablets each.

Patients taking Losartan Potassium from the affected lots should consult their healthcare provider or pharmacist to determine if their medication is included in this recall. Do not stop taking the medication without medical guidance.

The recalled product

Product
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
Manufacturer
Preferred Pharmaceuticals, Inc.
Category
Drug — Antihypertensive
Hazard

Is your product affected?

Check your packaging against the codes below. If any of them match, the product is part of this recall.

Lot numbers (4)

  • Lot: E1321O
  • Exp.: 5/31/2023 Lot: E2521H
  • Exp.: 5/31/2023 Lot: E2621F
  • Exp.: 5/31/2023

Distribution

Distributed nationwide across the United States.

The notice also names 3 states specifically:

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