Agency classClass IIOur severity:Moderate FDA (Drugs)·D-1005-2019·Announced 2019-03-20

Macleods Pharma Recalls Telmisartan and Hydrochlorothiazide Tablets for Blend Uniformity

Macleods Pharma USA is recalling Telmisartan and Hydrochlorothiazide tablets because they failed content uniformity specifications for blend uniformity.

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 2/5 (Moderate).

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

Our severity reasoning: FDA Class II recall for a prescription drug with a quality control issue (blend uniformity) and no reported injuries or illnesses, fitting the criteria for moderate severity.

Plain-English summary

Macleods Pharma USA, Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets 80 mg/25 mg, 30-count bottles. The product is manufactured by Macleods Pharmaceuticals Ltd. in India and distributed nationwide within the United States. The recall involves 134,495 bottles with NDC 33342-130-07.

The recall was initiated because the product failed content uniformity specifications, specifically for blend uniformity. This means the active ingredients may not be evenly distributed throughout the tablets.

Consumers with these specific lot numbers should contact their healthcare provider or pharmacist for guidance. The affected lots include BTN703A through BTN814A with expiration dates ranging from February 2019 to September 2020.

The recalled product

Product: Telmisartan and Hyrdochlorothiazide Tablets 80 mg/25 mg, 30-count bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi Himachal Pradesh, INDIA, NDC 33342-130-07
Manufacturer: Macleods Pharma Usa Inc
Category: Drug — Prescription Medication
Hazard: blend-uniformity
content-uniformity
Affected units: 134,495

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 (20)

Lot #: BTN703A
BTN704A Exp Feb-19
BTN705A
BTN706A
Exp May-19
BTN707A
Exp Jun-19
BTN810A
Exp Jun-20
BTN811A
BTN812A Exp Aug-20
BTN813A
BTN814A
Exp Sep-20
BTN802A
BTN802B
BTN803A
BTN804A
Exp Dec-19
BTN805A

Distribution

Distributed nationwide across the United States.

Part of a larger recall action

This product is one of 3 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 3 products in this recall →

Same manufacturer · Macleods Pharma Usa Inc

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Same hazard · blend uniformity