Full List of FDA Losartan Recalls Through 2017

Home » Blog » Full List of FDA Losartan Recalls Through 2017

To date there have been 12 total Losartan recalls from the FDA, with eight of them stemming from two separate events. The largest recall, made up of three distinct orders, affected over 90,000 bottles of the popular generic.

Finding info on any given Losartan recall can take a bit of work, thanks to the way the information is presented by the FDA. Below, we’ve simplified the data on the 12 recalls of this high blood pressure medication, giving the dates, numbers of affected bottles, manufacturers, lot numbers, and the reason for each recall.

Losartan Recalls

There have been 12 total recalls of Losartan through 2017. The recalls were either ordered by the FDA or initiated voluntarily by the manufacturers.

The affected businesses were Apotex, GSMS, AidaPak, Jubilant Cadista Pharmaceuticals, Micro Labs USA, and Attix Pharmaceuticals.

Several of the recalls were minor. For example, in one recall in 2014, Micro Labs USA recalled 144 bottles of the drug for a failed content uniformity specification. In two other cases, the FDA levied several recall orders against the same manufacturer on the same day. The recalls in these cases all originated from a single event, but affected different dosages of the drug.

The full list of all Losartan recalls through 2017 is below.

Losartan Facts

Via: NIH.gov

Losartan is an angiotensin II receptor antagonist. It prevents the narrowing of blood vessels, which improves blood flow and lowers blood pressure. It’s used for the treatment of high blood pressure and to decrease the risk of stroke in some patients.

Losartan is also used to slow the progression of kidney damage for type 2 diabetes patients with high blood pressure.

Serious side effects of Losartan include allergic reaction, breakdown of skeletal muscles, and kidney failure. More common side effects are flu-like symptoms, muscle cramps, diarrhea, insomnia, and fatigue.

Major Losartan Recalls

There has only been one major recall of Losartan to date, involving just over 90,000 bottles of the popular blood pressure medication. It involved bottles of tablets made for Apotex, Inc.

The recall spanned three distinct FDA orders in 2015, affecting upwards of 20,000 bottles each. The separate recall orders targeted different dosages of the drug.

A much smaller recall of less than a thousand tablets total from Aidapak Services in 2014 involved five separate recall orders for different dosage sizes.

For a complete view of all Losartan recalls to date, scroll down to the sections below.

Losartan Manufacturers

Dozens of companies make Losartan. There’s a partial list here.

  • Alembic Pharmaceuticals
  • Cadista Pharmaceuticals
  • Jubilant Cadista Pharmaceuticals
  • Apotex Corporation
  • IPCA Laboratories
  • Aurobindo Pharmaceuticals
  • Micro Labs, India
  • Mylan Pharmaceuticals
  • Teva Pharmaceuticals
  • Unichem Laboratories

Full List of All Losartan Recalls

Via: NIH.gov

Here’s the full list of all 12 FDA Losartan recalls. It includes several separate recall orders for two larger recall events. It also displays multiple lesser recalls, affecting fewer than 5,000 bottles each.

Class I, Class II, and Class III Recalls Defined

Losartan recalls are identified by their FDA class numbers. For reference, the three groupings are defined here.

Class I Recall. Urgent. Impending danger of death or serious injury. Rare. There are no Class I recalls of Losartan shown below.

Class II Recall. Serious. Danger of death or serious injury, though not immediate. Most of the recalls listed below are Class II.

Class III Recall. For violations of FDA regulations without risk of death or injury. There are no Class III recalls of Losartan below.

Recall Date vs Issued Date

Below, FDA recalls of Losartan are shown in reverse chronological order, by the date the order was classified. The first bullet point for each event shows the date it was originally issued.

7/7/2015 Losartan Recall, Class II

  • Recall issued 5/29/2015.
  • 25 mg Losartan Potassium Tablets, 90-count bottle.
  • Manufactured for Apotex
  • Reason: Failed Content Uniformity Specs.
  • 45,708 bottles.
  • Lot # KP4726.

7/7/2015 Losartan Recall, Class II

  • Recall issued 5/29/2015.
  • 100 mg Losartan Potassium Tablets, 90-count bottle.
  • Manufactured for Apotex
  • Reason: Failed Content Uniformity Specs.
  • 23,178 bottles.
  • Lot # KT3819, KT3821.

7/7/2015 Losartan Recall, Class II

  • Recall issued 5/29/2015.
  • 50 mg Losartan Potassium Tablets, 90-count bottle.
  • Manufactured for Apotex
  • Reason: Failed Content Uniformity Specs.
  • 23,076 bottles.
  • Lot # KN1449.

6/2/2014 Losartan Recall, Class II

  • Recall issued 4/14/2014.
  • 50 mg Losartan Potassium Tablets, 30-count bottle.
  • Manufactured for Golden State Medical Supply
  • Reason: Foreign Substance Present.
  • 6,042 bottles.
  • Lot # GS003057.

7/31/2014 Losartan Recall, Class II

  • Recall issued 7/11/2014.
  • 100 mg Losartan Potassium Tablets, 90-count bottle.
  • Manufacturer: Jubilant Cadista Pharmaceuticals
  • Reason: Foreign Substance Present.
  • 9,358 bottles.
  • Lot # 14P0292.

11/18/2014 Losartan Recall, Class II

  • Recall issued 9/22/2014.
  • 25 mg Losartan Potassium Tablets, 1000-count bottle.
  • Manufactured for Micro Labs USA
  • Reason: Failed Content Uniformity Specs.
  • 144 bottles.
  • Lot #LJAG003.

4/20/2015 Losartan Recall, Class II

  • Recall issued 11/14/2014.
  • Losartan Potassium packaged in bags or drums.
  • Manufactured for Attix Pharmaceuticals.
  • Reason: Penicillin Cross Contamination.
  • 6525 grams.
  • All lots repackaged and distributed between 01/05/12 to 02/12/15.

1/20/2014 Losartan Recall, Class II

  • Recall issued 7/2/2013.
  • 25 mg Losartan Potassium Tablets.
  • Manufactured for Aidapak Services
  • Reason: Label Mixup.
  • 90 tablets.
  • Pedigree: AD46312_16.
Via: NIH.gov

1/20/2014 Losartan Recall, Class II

  • Recall issued 7/2/2013.
  • 50 mg Losartan Potassium Tablets.
  • Manufactured for Aidapak Services
  • Reason: Label Mixup.
  • 90 tablets.
  • Pedigree: W003268.

1/20/2014 Losartan Recall, Class II

  • Recall issued 7/2/2013.
  • 50 mg Losartan Potassium Tablets.
  • Manufactured for Aidapak Services
  • Reason: Label Mixup.
  • 90 tablets.
  • Pedigree: AD21965_10.

1/16/2014 Losartan Recall, Class II

  • Recall issued 7/2/2013.
  • 25 mg Losartan Potassium Tablets.
  • Manufactured for Aidapak Services
  • Reason: Label Mixup.
  • 180 tablets.
  • Pedigree: AD65323_10.

1/16/2014 Losartan Recall, Class II

  • Recall issued 7/2/2013.
  • 25 mg Losartan Potassium Tablets.
  • Manufactured for Aidapak Services
  • Reason: Label Mixup.
  • 448 tablets.
  • Pedigree: AD67989_7, W003845, W003899, AD22616_7.

Conclusion

The list above shares the 12 Losartan recalls as of 6/22/17. The biggest was 2015’s Apotex recall of over 90,000 bottles of different pill counts and dosages. The next biggest recall involved 9,358 bottles made by Jubilant Cadista Pharmaceuticals in 2014. For one of the ten most popular generics on the market, the total of 150,000 bottles recalled is actually relatively low.

Disclosure: The images on this page are for illustration only and don’t necessarily reflect actual recalled medication.

 

Find Out How Much You Can Save Instantly.
Try our on-line savings calculator.