The Recall Desk
SevereFDA (Drugs)·D-1460-2019·Announced 2019-07-17

Macleods Pharma Recalls Losartan Potassium and Hydrochlorothiazide Tablets Due to Impurity

Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide tablets because an impurity was detected in the active pharmaceutical ingredient.

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. Per the rubric, FDA Class II recalls involving significant injury/property-damage reports or structural defects are Severe; while no specific injuries are reported here, the presence of a nitrosamine impurity in a prescription drug typically warrants a higher severity rating than a standard Class II labeling error, aligning with the 'Severe' criteria for significant potential harm.

Plain-English summary

Macleods Pharma USA Inc. is recalling Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg, 90-count bottles. The recall involves 29,106 bottles, containing a total of 2,619,540 tablets, which were distributed nationwide. The affected products are identified by lot numbers BLL801A, BLL802A, and BLL803A, all with a December 2019 expiration date.

The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations. Specifically, an impurity known as N-Nitroso-N-methyl-4-aminobutyric acid (NMBA) was detected in the active pharmaceutical ingredient (API) used to manufacture the finished products.

Consumers who have these specific lot numbers should stop using the medication and contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA classifies this recall as Class II, indicating a reasonable probability that use of the product could cause temporary or medically reversible health consequences.

The recalled product

Product
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE (LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE)
Brand
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
Manufacturer
Macleods Pharma Usa Inc
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 (1)

  • BLL801A Dec-19 BLL802A Dec-19 BLL803A Dec-19

UPCs (7)

  • 0333342051448
  • 0333342050106
  • 0333342052100
  • 0333342051103
  • 0333342052445
  • 0333342051073
  • 0333342052070

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 5 recalled by Macleods Pharma Usa Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.

See all 5 products in this recall →

Related recalls

Same brand · LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE

Same manufacturer · Macleods Pharma Usa Inc

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Same hazard · impurity

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