The Recall Desk
SevereFDA (Drugs)·D-1281-2019·Announced 2019-05-22

Preferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity

Preferred Pharmaceuticals is recalling Losartan Potassium 50mg tablets because FDA testing found an impurity above acceptable levels.

What this means for you

Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.

Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe severity score under the rubric for significant injury or property damage reports or high-risk contamination.

Plain-English summary

Preferred Pharmaceuticals, Inc. is recalling Losartan Potassium Tablets USP 50mg, available in 30-count and 90-count bottles. The recall is due to Current Good Manufacturing Practice (CGMP) deviations. FDA laboratory testing confirmed the presence of the impurity N-Methylnitrosobutyric acid (NMBA) in the finished product at levels above the interim acceptable daily intake limit at the manufacturer.

The affected products are distributed in California, Georgia, and Indiana. The recall does not include Department of Defense, Veterans Affairs, or foreign accounts. Specific lot and batch information is provided for the 30-count and 90-count bottles, both with an expiration date of March 2020.

Consumers and healthcare providers should stop using the affected lots and return them to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.

The recalled product

Product
Losartan Potassium Tab. USP 50mg, a) 30 count bottle (NDC 68788-0048-03) and b) 90 count bottle (NDC 68788-0048-09), Rx only, Preferred Pharmaceuticals, Inc., Anaheim, CA, Mfg: Torrent Pharma Inc., Basking Ridge, NJ

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 (2)

  • a) 30 tablets: lot A1818G batch 01181807 exp 3/2020
  • b) 90 tablets: lot L0517L batch 12051712 exp 3/2020

Distribution

Distributed in 3 states: