The Recall Desk
ModerateFDA (Drugs)·D-1003-2019·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 blend uniformity specifications.

What this means for you

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: The recall is classified as FDA Class II, and the source text does not report any illnesses or injuries, fitting the criteria for a moderate severity score involving low-risk contamination or specification failures without reported harm.

Plain-English summary

Macleods Pharma USA, Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles. The recall affects 93,227 bottles distributed nationwide within the United States. The specific lots involved include BTL703A through BTL813A, with expiration dates ranging from February 2019 to October 2020.

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

Consumers who have these specific bottles should stop using them and contact their healthcare provider or pharmacist for guidance on alternative treatment options.

The recalled product

Product
Telmisartan and Hyrdochlorothiazide Tablets 40mg/12.5 mg, 30-count bottles, Rx Only, Manufactured for:Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured for: Macleods Pharmaceuticals Ltd. Baddi, Himchal Pradesh INDIA, NDC 33342-128-07
Manufacturer
Macleods Pharma Usa Inc
Category
Drug — Prescription Medication
Hazard
Affected units
93,227

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 #: BTL703A
  • Exp. Feb-19
  • BTL705A
  • Exp Apr-19
  • BTL706A
  • BTL707A
  • BTL708A
  • Exp May-19
  • BTL709A
  • Exp Nov-19
  • BTL710A
  • BTL711A
  • BTL801A
  • Exp. Dec-19
  • BTL802A
  • BTL803A
  • Exp.Feb-20
  • BTL804A
  • BTL805A
  • Exp. Apr-20

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 →

Related recalls

Same manufacturer · Macleods Pharma Usa Inc

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Same hazard · blend uniformity

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