Major Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
Major Pharmaceuticals is recalling Losartan Potassium 50 mg tablets because FDA testing found an impurity above acceptable levels.
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 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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' rating under the rubric, particularly given the presence of a nitrosamine impurity.
Plain-English summary
Major Pharmaceuticals is recalling Losartan Potassium Tablets, USP, 50 mg (NDC# 0904-6390-61). The recall involves 3,102 cartons containing 310,200 tablets. The affected product is Lot Number R-00474 with an expiration date of 07/2019.
The recall was initiated 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.
The product was distributed nationwide. Consumers and healthcare providers should check their inventory for this specific lot number and expiration date. If found, the product should be returned to the pharmacy or supplier for disposal or credit.
The recalled product
- Product
- Losartan Potassium Tablets, USP. 50 mg. NDC# 0904-6390-61. Rx only. 100 count Unit Dose Cartons. Manufactured by Major Pharmaceuticals 17177 N. Laurel Park Drive Suite 233, Livonia, MI 48152.
- Manufacturer
- MAJOR PHARMACEUTICALS
- Category
- Drug — Prescription Medication
- 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 (2)
- Major Label Unit Does 10 x 10 Cartons
- Major Item # 301835. Lot Number: R-00474. Expiration date: 07/2019.
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · MAJOR PHARMACEUTICALS
See all →- HighLevothyroxine Sodium Tablets Recalled for Subpotency by Major Pharmaceuticals
FDA (Drugs) · 2026-07-29
- SevereMajor Pharmaceuticals Recalls Levothyroxine Sodium Tablets Over Subpotency
FDA (Drugs) · 2026-07-29
- SevereLevothyroxine Sodium Tablets Recalled for Subpotency Nationwide
FDA (Drugs) · 2026-07-29
- HighLevothyroxine Sodium Tablets Recalled Due to Subpotent Drug Concerns
FDA (Drugs) · 2026-07-29
- SevereLevothyroxine Sodium Tablets Recalled for Subpotency
FDA (Drugs) · 2026-07-29
Same hazard · impurity
See all →- ModerateAjanta Pharma Recalls Fluphenazine Hydrochloride Tablets Due to Impurity Failure
FDA (Drugs) · 2026-09-16
- ModerateHikma Recalls Ramipril Capsules Due to Process Impurity
FDA (Drugs) · 2026-09-02
- ModerateMedline Remedy Specialized Silicone Cream Recalled for Elevated Formaldehyde Levels
FDA (Drugs) · 2026-07-15
- SevereCinacalcet Hydrochloride Tablets Recalled for Elevated Impurity Levels
FDA (Drugs) · 2026-07-08
- HighDuloxetine 60mg delayed-release capsules exceed nitrosamine impurity interim limit
FDA (Drugs) · 2026-06-17
Similar recalls
- SeverePreferred Pharmaceuticals Recalls Losartan Potassium Tablets Due to Impurity
FDA (Drugs) · 2019-05-22
- SevereLosartan Potassium Tablets Recalled Due to Impurity Detection
FDA (Drugs) · 2019-07-17
- SevereLosartan Potassium Tablets Recalled Due to Nitrosamine Impurity
FDA (Drugs) · 2019-07-17
- SevereLosartan Potassium Tablets Recalled Due to Impurity Presence
FDA (Drugs) · 2019-05-29
- SevereAvKARE Recalls Losartan Potassium Tablets Due to Impurity
FDA (Drugs) · 2019-05-08
- SevereMajor Pharmaceuticals Recalls Valsartan Tablets Due to Carcinogen Impurity
FDA (Drugs) · 2018-08-01