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Class III: unlikely to cause harmTerminated

Torrent Pharma Telmisartan and Hydrochlorothiazide Tablets Recall

Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12

Torrent Pharma Inc. · Basking Ridge, NJ

Risk level
Class III
Reported by FDA
Dec 22, 2021
Recall ID
D-0285-2022
Check your lot numberHow we source this data

Summary

Torrent Pharma recalled Telmisartan and Hydrochlorothiazide Tablets starting Dec 1, 2021. The FDA classified it as Class III (unlikely to cause harm) and published enforcement report D-0285-2022 on Dec 22, 2021. Reason: Superpotent; Hydrochlorothiazide. Status: Terminated.

Why it was recalled

Superpotent; Hydrochlorothiazide

Product description

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

Lot numbers, UPCs & expiration codes

Batch: BZ74G001 Exp. 12/2021.

Where it was sold

Nationwide USA

What to do if you have this product

  • Compare the lot number and expiration date on your package with the codes above.
  • Don't stop taking a prescription medicine on your own. Call your pharmacist or doctor; they can confirm whether your supply is affected and arrange a replacement.
  • If you have symptoms you think are related, contact your doctor. In an emergency call 911.
  • Report side effects to FDA MedWatch at 1-800-FDA-1088.

Recall details

Recall number
D-0285-2022
Classification
Class III
Status
Terminated
Recall initiated
Dec 1, 2021
FDA report date
Dec 22, 2021
Quantity
27,312 Bottles
Recall type
Voluntary: Firm initiated
Recalling firm
Torrent Pharma Inc.

Original FDA data

Every field from FDA enforcement report D-0285-2022, exactly as published.

Show all FDA fields
City
Basking Ridge
State
NJ
Status
Terminated
Country
United States
Event ID
89141
Address
150 Allen Rd Ste 102
Code information
Batch: BZ74G001 Exp. 12/2021.
Postal code
07920-3856
Report date
Dec 22, 2021
Product type
Drugs
Recall number
D-0285-2022
Classification
Class III
Recalling firm
Torrent Pharma Inc.
Product quantity
27,312 Bottles
Termination date
May 12, 2024
Reason for recall
Superpotent; Hydrochlorothiazide
Voluntary / mandated
Voluntary: Firm initiated
Product description
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
Distribution pattern
Nationwide USA
Recall initiation date
Dec 1, 2021
Initial firm notification
Letter
Center classification date
Dec 16, 2021

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0285-2022, published Dec 22, 2021. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: . Content last changed: .

FindMyRecall is an independent service and is not affiliated with or endorsed by the FDA. This page simplifies the official record; the FDA or manufacturer notice is authoritative, so follow its instructions. Medication information here is not individualized medical advice.

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