Drug recall: Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial…

Class II FDA enforcement event 82463. Recall start date: 22 Mar 2019. Status in the FDA record: Terminated. Termination date: 16 Aug 2022.

Reason for recall, in the words of FDA

Presence of Particulate Matter.

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

InvaGen Pharmaceuticals, Inc. started this drug recall on 22 Mar 2019. The firm address in the FDA record is in Central Islip, NY. FDA put the recall in Class II. FDA event 82463 has 3 product records. The first FDA enforcement report date is 24 Apr 2019. The record gives the status Terminated, with the termination date 16 Aug 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.

Nationwide in the U.S.A.

Recalling firm

InvaGen Pharmaceuticals, Inc., Central Islip, NY.

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 82463: product records
Recall number	Product	Quantity	Class	Status	Report date
D-1123-2019	Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37.	12234 vials	Class II	Terminated	24 Apr 2019
D-1124-2019	Testosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31.	692538 vials	Class II	Terminated	24 Apr 2019
D-1125-2019	Testosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.	75968 vials	Class II	Terminated	24 Apr 2019

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 2019: 362
Share of these events in Class II: 68%
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 InvaGen Pharmaceuticals, Inc.
Initiated	Product (first record)	Type	Class	Records
17 Nov 2023	Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceutica	Drug	Class I	1
14 May 2020	Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville	Drug	Class III	1
12 Jun 2019	Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total	Drug	Class III	1
3 Oct 2018	Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manuf	Drug	Class III	1
6 Sep 2018	Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cip	Drug	Class III	1
15 Mar 2018	buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 15	Drug	Class III	2
5 Mar 2018	Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla	Drug	Class III	1

InvaGen Pharmaceuticals, Inc.: all 8 events

Official channels

FDA enforcement report D-1123-2019The 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 82463. https://recallregister.com/fda/ii/82463/. 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 U.S.A.
What quantity of product is in FDA event 82463?: The event has 3 product records. The first record gives this quantity: 12234 vials
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2019 have the same class?: 68% of the 362 drug events that started in 2019 are in Class II.