CLASS III Drug recall · Reported 22 Dec 2021 · FDA Enforcement Report
Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled
Torrent Pharma is recalling Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, distributed nationwide in the US. The recall was initiated on 1 Dec 2021 and the FDA has classified it as Class III.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-0285-2022
- FDA event ID
- 89141
- Recalling firm
- Torrent Pharma, Basking Ridge, NJ
- Classification
- Class III
- Status
- Terminated
- Recall initiated
- 1 Dec 2021
- FDA classified
- 16 Dec 2021
- Reported
- 22 Dec 2021
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Potency & Assay
- Drug class
- Blood Pressure Medication
Timeline
| 1 Dec 2021 | Recall initiated by company | |
| 16 Dec 2021 | Classified by FDA | +15 days |
| 22 Dec 2021 | Published in enforcement report | +6 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
Superpotent; Hydrochlorothiazide
Potency and specification recalls happen when a batch tests outside its approved limits for strength, purity or dissolution, which can mean the dose delivered is higher or lower than labelled.
Product as listed by the FDA
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
Where it was distributed
Nationwide USA
Questions about this recall
Is Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg recalled?
Yes. Torrent Pharma recalled Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg on 1 Dec 2021. The recall is Class III and its status is Terminated. Recall number D-0285-2022.
Why was it recalled?
Superpotent; Hydrochlorothiazide
Which lots are affected?
Batch: BZ74G001 Exp. 12/2021.
Where was it sold?
Nationwide USA
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class III mean?
Class III recalls are for products unlikely to cause any adverse health consequence, usually labelling or quality issues.
Read the official FDA notice · Source record retrieved 21 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
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|---|---|---|---|---|---|
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