Drug recall: buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc.…

Class III FDA enforcement event 79446. Recall start date: 15 Mar 2018. Status in the FDA record: Terminated. Termination date: 15 Sep 2021.

Reason for recall, in the words of FDA

Failed Dissolution Specifications; during stability testing

Class III, in the words of FDA

a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences

InvaGen Pharmaceuticals, Inc. started this drug recall on 15 Mar 2018. The firm address in the FDA record is in Hauppauge, NY. FDA put the recall in Class III. FDA event 79446 has 2 product records. The first FDA enforcement report date is 11 Apr 2018. The record gives the status Terminated, with the termination date 15 Sep 2021.

FDA enforcement report The 2 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

Recalling firm

InvaGen Pharmaceuticals, Inc., Hauppauge, NY.

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

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

Products

2 product records in the event.

FDA event 79446: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0618-2018	buPROPion HCl Extended-Release Tablets, USP (SR), 100 mg, 60 count bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 --- NDC 69097-877-03	N/A	Class III	Terminated	11 Apr 2018
D-0619-2018	buPROPion HCl Extended-Release Tablets, USP (SR), 150 mg ,a) 60 count (NDC 69097-878-03) and b) 100 count (NDC 69097-878-07) bottles, Rx Only, Manufactured for: Cipla USA Inc. 1560 Sawgrass Corporate Parkway Suite 130 Sunrise, FL 33323, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.)…	N/A	Class III	Terminated	11 Apr 2018

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 III: The lowest of the three FDA recall classes.

The event in context

Drug events that started in 2018: 367
Share of these events in Class III: 29%
Product records in this event: 2Median 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
22 Mar 2019	Testosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose,	Drug	Class II	3
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
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-0618-2018The 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.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 79446. https://recallregister.com/fda/iii/79446/. 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
What quantity of product is in FDA event 79446?: The event has 2 product records. The first record gives this quantity: N/A
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2018 have the same class?: 29% of the 367 drug events that started in 2018 are in Class III.