Torrent Pharma Recalls Amlodipine, Valsartan, and Hydrochlorothiazide Tablets Due to Impurity
Torrent Pharma Inc. is recalling specific lots of Amlodipine, Valsartan, and Hydrochlorothiazide tablets because a carcinogen 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, and the source text explicitly identifies a carcinogen impurity, which represents a significant health hazard and potential for serious injury.
Plain-English summary
Torrent Pharma Inc. is recalling 50,784 bottles of Amlodipine, Valsartan, and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg. The affected product is a prescription medication manufactured by Torrent Pharmaceuticals LTD. in India and distributed nationwide in the United States.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the detection of a carcinogen impurity in the active pharmaceutical ingredient (API) used to manufacture the drug product. The affected batch numbers are BBY1E001, BBY1E003, BBY1C002, BBY1E002, and BBY1D001.
Patients and healthcare providers should check their medication bottles for the NDC 13668-326-30 and the specific batch numbers listed above. If the product matches the recalled description, patients should stop using it and contact their healthcare provider or pharmacist for guidance on alternative treatment options.
The recalled product
- Product
- Amlodipine, Valsartan and Hydrochlorothiazide Tablets, USP, 5 mg/160 mg/12.5 mg, 30 tablets per bottle, Rx Only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. NDC: 13668-326-30
- Manufacturer
- Torrent Pharma Inc.
- Category
- Drug — Prescription Medication
- Affected units
- 50,784
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 (5)
- Batch: BBY1E001
- BBY1E003
- BBY1C002
- BBY1E002
- BBY1D001
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 12 recalled by Torrent Pharma 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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