Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, Rx Only, 90 tablets per bottle, Manufactured by: Torrent Pha... — FDA record D-0852-2022

Reported terminated

Status as reported in the agency record. FDA warns that enforcement status may not track the current recall lifecycle; check the current official notice.

Source date Apr 11, 2022. Retrieved Oct 1, 2026. Last updated Oct 1, 2026.

Archive changed Oct 1, 2026. USDA FSIS records are unavailable; check FSIS directly. Source coverage and dates.

What the record says

Product
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.
Reason
CGMP deviations: tablets cracking
Classification
Class II
Recalling firm
Torrent Pharma Inc
Quantity
24,888 bottles
Agency-reported status
Terminated
Source record identifier
D-0852-2022

Open the official record

What the recall classes mean. Classification is an agency assessment, not individual medical advice.

Lot and product identifiers

Label fieldDetails supplied by the agency
Lot, code or applicabilityLot #s: BA34G021, BA34G022, Exp. 09/2022

Match all identifying details in the current notice. A brand name alone is not enough.

Distribution

Nationwide in the U.S.A

States below are derived from the distribution text, including nationwide wording. They are not inferred from the firm's address.

Dates in the source

Report date
May 11, 2022
Recall initiation date
Apr 11, 2022
Center classification date
May 5, 2022
Termination date
Jul 25, 2023

FDA company pages use the listing date; enforcement records use initiation dates; CPSC uses recall date; NHTSA uses report-received date. These dates are not interchangeable.

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