CLASS II Drug recall · Reported 23 Oct 2019 · FDA Enforcement Report
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg recalled
Jubilant Cadista Pharmaceuticals is recalling Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, distributed in Mississippi, Ohio, Puerto Rico, Rhode Island, Tennessee. The recall was initiated on 4 Sep 2019 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-0145-2020
- FDA event ID
- 83705
- Recalling firm
- Jubilant Cadista Pharmaceuticals, Salisbury, MD
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Sep 2019
- FDA classified
- 17 Oct 2019
- Reported
- 23 Oct 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Manufacturing (CGMP) Deviations
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 4 Sep 2019 | Recall initiated by company | |
| 17 Oct 2019 | Classified by FDA | +43 days |
| 23 Oct 2019 | 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 Deviation: Presence of dark brown discoloration on edges of tablets.
Product as listed by the FDA
Pantoprazole Sodium Delayed Release Tablets, USP, 40 mg, packaged in 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd, Roorkee - 247661, India, Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801, NDC 59746-284-90
Where it was distributed
Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
Questions about this recall
Why was it recalled?
CGMP Deviation: Presence of dark brown discoloration on edges of tablets.
Which lots are affected?
Lot # PA218P008, PA218P009, Exp 04/2021
Where was it sold?
Product was distributed to MS, OH, RI, TN and Puerto Rico to distributors and wholesalers who may have further distributed the product to the retail level.
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.
More recalls from Jubilant Cadista Pharmaceuticals
All 31| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS III | Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Irbesartan Tablets, USP, 75 mg recalled by Jubilant CadistaIrbesartan | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS III | Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista | Jubilant Cadista Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS I | Meclizine Hydrochloride Tablets USP, 12.5 mg recalledMeclizine Hydrochloride | Jubilant Cadista Pharmaceuticals | Labeling Errors | 5 states |
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 |