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. The recall covers 140,589 bottles distributed nationwide.
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 due to a failure in blend uniformity, which is a quality control issue that may lead to inconsistent dosing but is not associated with reported serious injuries or deaths in the source text.
Plain-English summary
Macleods Pharma USA, Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets, USP 80mg/12.5 mg, 30-count bottles. The recall is due to the product failing content uniformity specifications, specifically for blend uniformity. The affected product is prescription-only and was manufactured by Macleods Pharmaceuticals Ltd. in India for Macleods Pharma USA, Inc. in Plainsboro, NJ.
The recall involves 140,589 bottles distributed nationwide within the United States. Specific lot numbers and expiration dates are listed in the recall documentation, ranging from February 2019 to November 2020. The NDC number for the product is 33342-129-07.
Consumers with this medication should contact their healthcare provider or pharmacist for guidance on alternative treatment options. The FDA classifies this as a Class II recall, indicating a reasonable probability that the use of the product may cause temporary or medically reversible adverse health consequences.
The recalled product
- Product
- Telmisartan and Hyrdochlorothiazide Tablets, USP 80mg/12.5 mg, 30-coun bottles, Rx Only, Manufactured for: Macleods Pharma USA, Inc. Plainsboro, NJ 08536 Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Imachal Pradesh, India NDC 33342-129-07
- Manufacturer
- Macleods Pharma Usa Inc
- Category
- Drug — Prescription Medication
- Affected units
- 140,589
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 #: BTM703A
- BTM704A
- BTM706A
- BTM707A
- Exp Feb-19
- TM708A
- BTM709A
- Exp Apr-19
- BTM710A
- Exp Jun-19
- BTM711A
- BTM712A
- Exp Oct-19
- BTM713A
- BTM714A
- BTM715A
- Exp Nov-19
- BTM801A
- BTM802A
- BTM803A
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.
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