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

Class II FDA enforcement event 91855. Recall start date: 14 Mar 2023. Status in the FDA record: Ongoing.

Reason for recall, in the words of FDA

CGMP Deviations: Discoloration

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 USA Inc started this drug recall on 14 Mar 2023. The firm address in the FDA record is in Piscataway, NJ. FDA put the recall in Class II. FDA event 91855 has 1 product record. The first FDA enforcement report date is 19 Apr 2023. 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 within the United States

Recalling firm

Hetero USA Inc, Piscataway, NJ.

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

FDA records how the recall started: N/A.

Products

1 product record in the event.

FDA event 91855: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0530-2023	Pantoprazole Sodium Delayed Release Tablets USP 40mg, 1000-count bottles, Rx only, Manufactured for: Camber Pharmaceuticals Inc., Piscataway, NJ, 08854, By: Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahabubnagar- 509 301, India NDC 31722-713-10	2,352 bottles	Class II	Ongoing	19 Apr 2023

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 2023: 281
Share of these events in Class II: 59%
Product records in this event: 1Median of the firm: 1
Events of the firm on the register: 4

Other events of the firm

Other FDA enforcement events of Hetero USA Inc
Initiated	Product (first record)	Type	Class	Records
20 Jul 2017	Entecavir Tablets 0.5 mg, 30 tablets per container, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,	Drug	Class II	1
27 Apr 2017	Acyclovir Tablets, USP, 800 mg, 100-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, N	Drug	Class III	1
7 Jan 2017	Montelukast sodium tablets, 10 mg, 30-count bottle, Rx Only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway,	Drug	Class III	1

Hetero USA Inc: all 4 events

Official channels

FDA enforcement report D-0530-2023The 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 91855. https://recallregister.com/fda/ii/91855/. 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 within the United States
What quantity of product is in FDA event 91855?: The FDA record gives this quantity: 2,352 bottles
How many drug recalls of 2023 have the same class?: 59% of the 281 drug events that started in 2023 are in Class II.
How many FDA recalls does Hetero USA Inc have?: Hetero USA Inc is the recalling firm in 4 enforcement events on this register. This event is 1 of them.