Drug recall: Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured…

Class II FDA enforcement event 87038. Recall start date: 17 Dec 2020. Status in the FDA record: Terminated. Termination date: 7 Dec 2022.

Reason for recall, in the words of FDA

Cross- contamination with other products: The excipient, Crospovidone, NF is contaminated with theophylline

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

CIPLA started this drug recall on 17 Dec 2020. The firm address in the FDA record is in Warren, NJ. FDA put the recall in Class II. FDA event 87038 has 3 product records. The first FDA enforcement report date is 6 Jan 2021. The record gives the status Terminated, with the termination date 7 Dec 2022.

FDA enforcement report The 3 product records

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.

U.S.A. Nationwide

Recalling firm

CIPLA, Warren, NJ.

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

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

Products

3 product records in the event.

FDA event 87038: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0181-2021	Esomeprazole Magnesium for Delayed-Release Oral Suspension 10mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-527-34	284,610 packets	Class II	Terminated	6 Jan 2021
D-0182-2021	Esomeprazole Magnesium for Delayed-Release Oral Suspension 20mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059, NDC 69097-528-34	289350 packets	Class II	Terminated	6 Jan 2021
D-0183-2021	Esomeprazole Magnesium for Delayed-Release Oral Suspension 40mg, packaged in unit dose packets, Rx only, Manufactured by: Cipla Ltd., Kurkumbh, India, Manufactured for: Cipla USA, Inc. 10 Independence Boulevard, Suite 300 Warren, NJ 07059 NDC 69097-529-34	6,491 packets	Class II	Terminated	6 Jan 2021

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 2020: 342
Share of these events in Class II: 64%
Product records in this event: 3Median of the firm: 1
Events of the firm on the register: 8

Other events of the firm

Other FDA enforcement events of CIPLA
Initiated	Product (first record)	Type	Class	Records
29 Sep 2022	Arformoterol Tartrate Inhalation Solution, 15 mcg/2mL, 2 mL Sterile Unit-Dose Vial packaged in 5 x 2 mL Sterile Unit-Dos	Drug	Class II	1
15 Sep 2022	Budesonide Inhalation Suspension 0.25mg/2mL, For Inhalation Only, Rx Only, 1 envelope x five 2 mL Single Dose Ampules pe	Drug	Class II	1
22 Aug 2022	Difluprednate Ophthalmic Emulsion, 0.05%, 5 mL bottle, RX only, Manufactured for Exelan Pharmecuticals, Inc., Boca Raton	Drug	Class II	2
2 Aug 2022	Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., Ind	Drug	Class II	1
14 Jul 2022	Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipla Ltd., India At M/S Indoco Remedies Limite	Drug	Class II	1
10 Jun 2021	Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna, Goa, India Manufact	Drug	Class II	1
14 Dec 2020	Azacitidine for Injection 100 mg/vial For Subcutaneous and Intravenous Use Only Single-Dose Vial Manufactured by Shilpa	Drug	Class II	1

CIPLA: all 8 events

Official channels

FDA enforcement report D-0181-2021The 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 87038. https://recallregister.com/fda/ii/87038/. 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: U.S.A. Nationwide
What quantity of product is in FDA event 87038?: The event has 3 product records. The first record gives this quantity: 284,610 packets
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2020 have the same class?: 64% of the 342 drug events that started in 2020 are in Class II.