Drug recall: Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber…

Class II FDA enforcement event 98671. Recall start date: 26 Mar 2026. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

Discoloration: Firm received five (5) complaints stating that, "Tablets discolored darker than normal and have lighter-colored spots."

Class II, in the words of FDA

a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote

Hetero Labs Limited (Unit V) started this drug recall on 26 Mar 2026. The firm address in the FDA record is in Mahabubnagar. FDA put the recall in Class II. FDA event 98671 has 1 product record. The first FDA enforcement report date is 29 Apr 2026. The record gives the status Ongoing.

FDA enforcement report The 1 product record

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

Nationwide in the USA.

Recalling firm

Hetero Labs Limited (Unit V), Mahabubnagar, N/A, India.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

1 product record in the event.

FDA event 98671: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0484-2026	Pantoprazole Sodium, Delayed-Release Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadcherta, Mahabubager-509 301, India, NDC 31722-713-10	4,740 1,000-count bottles.	Class II	Ongoing	29 Apr 2026

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2026: 234
Share of these events in Class II: 74%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 7

Other events of the firm

Other FDA enforcement events of Hetero Labs Limited (Unit V)
Initiated	Product (first record)	Type	Class	Records
6 Aug 2020	Losartan Potassium Tablets USP, 50 mg, 90 count bottles, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscat	Drug	Class II	1
20 Aug 2018	Montelukast Sodium Tablets, 10 mg*, 30-count bottles, Rx Only, By: Hetero, Hetero Labs Limited, Unit V, Polepally, Jadch	Drug	Class II	1
15 Aug 2018	Montelukast Sodium Tablets 10 mg, 30-count bottle, Rx Only, By: Hetero Hetero Labs Limited, Unit V, Polepally, Jadcherla	Drug	Class I	1
8 Aug 2018	Camber Pharmaceuticals, Inc. Valsartan Tablets, USP, 40 mg, 30 Tablets Rx Only Manufactured for: Camber Pharmaceuticals,	Drug	Class II	4
13 Feb 2018	Valganciclovir Tablets, USP, 450 mg, 60-count bottle, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway,	Drug	Class II	2
22 Dec 2017	Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08	Drug	Class II	1

Hetero Labs Limited (Unit V): all 7 events

Official channels

FDA enforcement report D-0484-2026The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

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Cite this page

Recall Register. FDA enforcement event 98671. https://recallregister.com/fda/ii/98671/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: Nationwide in the USA.
What quantity of product is in FDA event 98671?: The FDA record gives this quantity: 4,740 1,000-count bottles.
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2026 have the same class?: 74% of the 234 drug events that started in 2026 are in Class II.