The Recall Desk
ModerateFDA (Drugs)·D-0285-2022·Announced 2021-12-22

Telmisartan and Hydrochlorothiazide Tablets Recalled for Superpotency

Torrent Pharma Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets USP 40 mg/12.5 mg due to superpotency. The affected batch (BZ74G001, expiring 12/2021) contains approximately 27,312 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: This is an FDA Class III recall involving a superpotency issue—a deviation from specifications that may affect drug safety. No illnesses or injuries are reported in the source text. Under the rubric, Class III recalls are typically scored 1 or 2; the presence of a potency deviation without reported harm places this at the Moderate level.

Plain-English summary

Torrent Pharma Inc. is recalling Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg in 30-count bottles. The recall was initiated due to a superpotency issue with the active ingredient Hydrochlorothiazide.

The affected product is identified by NDC 13668-159-30, manufactured by Torrent Pharmaceuticals LTD in Indrad, India, and distributed by Torrent Pharma Inc., Basking Ridge, New Jersey. The recalled batch is BZ74G001 with an expiration date of 12/2021. Approximately 27,312 bottles were distributed nationwide.

Patients taking this medication should consult their healthcare provider. Do not discontinue use without medical guidance, as Telmisartan and Hydrochlorothiazide is used to treat high blood pressure. Consumers with questions or concerns should contact Torrent Pharma Inc. or the FDA.

The recalled product

Product
Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bottles, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, India. Manufactured for: Torrent Pharma Inc., Basking Ridge, NJ 07920. NDC: 13668-159-30
Manufacturer
Torrent Pharma Inc.
Category
Drug — Antihypertensive / Combination Tablet
Hazard
  • superpotency
  • potency-deviation

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)

  • Batch: BZ74G001 Exp. 12/2021.

Distribution

Distributed nationwide across the United States.

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