CLASS II Drug recall · Reported 17 Oct 2018 · 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 nationwide in the US. The recall was initiated on 2 Oct 2018 and the FDA has classified it as Class II.

Check your package

Lot, batch or date codesLot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.

Quantity recalled158,466 bottles

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-0011-2019
FDA event ID: 81162
Recalling firm: Jubilant Cadista Pharmaceuticals, Salisbury, MD
Classification: Class II
Status: Terminated
Recall initiated: 2 Oct 2018
FDA classified: 9 Oct 2018
Reported: 17 Oct 2018
Type: Voluntary: Firm initiated
Customers notified by: Letter
Reason category: Other Reasons
Drug class: Stomach & Acid Reflux Medication

Timeline

2 Oct 2018	Recall initiated by company
9 Oct 2018	Classified by FDA	+7 days
17 Oct 2018	Published in enforcement report	+8 days

Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.

Reason for recall

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Product as listed by the FDA

Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 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 Nationwide in the USA and Puerto Rico.

Nationwide Puerto Rico

Questions about this recall

Why was it recalled?

Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.

Which lots are affected?

Lot #: PA26038A, Exp 04/19; PA26039A, PA26040A, PA26050A, Exp 05/19; PA26052A, Exp 06/19; PA26073A, Exp 07/19; PA217071A, PA217072A, PA217073B, PA217074B, Exp 06/20; PA217101A, Exp 08/20; and PA218023A, Exp 01/21.

Where was it sold?

Product was distributed Nationwide in the USA and Puerto Rico.

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

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11 Jan 2023Drug	CLASS III	Prochlorperazine Maleate Tablets, USP 5mg recalled by Jubilant CadistaProchlorperazine Maleate	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
3 Aug 2022Drug	CLASS II	Irbesartan Tablets, USP, 150mg recalled by Jubilant CadistaIrbesartan	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
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13 Apr 2022Drug	CLASS III	Methylprednisolone Tablets, USP 4mg recalled by Jubilant Cadista	Jubilant Cadista Pharmaceuticals	Potency & Assay	Nationwide
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Other Pantoprazole recalls

All 26

Reported	Class	Recall	Company	Reason	Where
9 Sep 2026Drug	CLASS II	Pantoprazole Sodium in 0.9% Sodium Chloride Injection recalledPantoprazole Sodium	Baxter Healthcare	Manufacturing (CGMP) Deviations	Nationwide
29 Apr 2026Drug	CLASS II	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg recalledPantoprazole Sodium	Hetero Labs Limited (Unit V)	Other	Nationwide
20 Sep 2023Drug	CLASS II	Pantoprazole Sodium for Injection 40mg per vial, Single dose vials recalledPantoprazole Sodium	BE Pharmaceuticals	Sterility	Nationwide
3 May 2023Drug	CLASS II	Pantoprazole sodium for Injection 40 mg*/vial, Single-dose Vial recalled	Methapharm	Manufacturing (CGMP) Deviations	Nationwide
19 Apr 2023Drug	CLASS II	Pantoprazole Sodium Delayed Release Tablets USP 40mg recalledPantoprazole Sodium	Hetero USA	Manufacturing (CGMP) Deviations	Nationwide