CLASS II Drug recall · Reported 11 May 2022 · FDA Enforcement Report
Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg recalled
Torrent Pharma is recalling Pantoprazole Sodium Delayed-Release Tablets, USP, 20 mg, distributed nationwide in the US. The recall was initiated on 11 Apr 2022 and the FDA has classified it as Class II.
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-0852-2022
- FDA event ID
- 89992
- Recalling firm
- Torrent Pharma, Levittown, PA
- Brand
- Pantoprazole Sodium
- Manufacturer
- Torrent Pharmaceuticals Limited
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 11 Apr 2022
- FDA classified
- 5 May 2022
- Reported
- 11 May 2022
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 11 Apr 2022 | Recall initiated by company | |
| 5 May 2022 | Classified by FDA | +24 days |
| 11 May 2022 | 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
CGMP deviations: tablets cracking
Product as listed by the FDA
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.
Where it was distributed
Nationwide in the U.S.A
Questions about this recall
Why was it recalled?
CGMP deviations: tablets cracking
Which lots are affected?
Lot #s: BA34G021, BA34G022, Exp. 09/2022
Where was it sold?
Nationwide in the U.S.A
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 II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 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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Other Pantoprazole recalls
All 26| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Pantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole Sodium | Baxter Healthcare | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium | Hetero Labs Limited (Unit V) | Other | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium for Injection 40mg per vial, Single dose vials recalledPantoprazole Sodium | BE Pharmaceuticals | Sterility | Nationwide |
| Drug | CLASS II | Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial recalled | Methapharm | Manufacturing (CGMP) Deviations | Nationwide |
| Drug | CLASS II | Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium | Hetero USA | Manufacturing (CGMP) Deviations | Nationwide |