Torrent Pharma Pantoprazole Sodium Delayed-Release Tablets Recall

Why it was recalled

CGMP deviations: tablets cracking

Product description

Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.

Lot numbers, UPCs & expiration codes

Lot #s: BA34G021, BA34G022, Exp. 09/2022

Where it was sold

Nationwide in the U.S.A

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-0852-2022
Classification: Class II
Status: Terminated
Recall initiated: Apr 11, 2022
FDA report date: May 11, 2022
Quantity: 24,888 bottles
Recall type: Voluntary: Firm initiated
Recalling firm: Torrent Pharma Inc

Original FDA data

Every field from FDA enforcement report D-0852-2022, exactly as published.

Show all FDA fields

City: Levittown
State: PA
Status: Terminated
Country: United States
Event ID: 89992
Address: 2091 Hartel Ave
Code information: Lot #s: BA34G021, BA34G022, Exp. 09/2022
Postal code: 19057-4506
Report date: May 11, 2022
Product type: Drugs
Recall number: D-0852-2022
Classification: Class II
Recalling firm: Torrent Pharma Inc
Product quantity: 24,888 bottles
Termination date: Jul 25, 2023
Reason for recall: CGMP deviations: tablets cracking
Voluntary / mandated: Voluntary: Firm initiated
Product description: Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pharmaceuticals Ltd., Indrad-382 721, India, Manufactured for: Torrent Pharma Inc., Levittown, PA 19057, NDC# 13668-096-90.
Distribution pattern: Nationwide in the U.S.A
Recall initiation date: Apr 11, 2022
Initial firm notification: Letter
Center classification date: May 5, 2022

How we source this data

Source: U.S. Food and Drug Administration enforcement report D-0852-2022, published May 11, 2022. View the source record (openFDA) · FDA enforcement reports

Last checked against FDA data: Oct 2, 2026. Content last changed: Oct 2, 2026.

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