Food, drugs, devices › InvaGen Pharmaceuticals, Inc.

Drug recall: Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cip

FDA enforcement event 80973 · Class III · initiated 6 Sep 2018 · status Terminated · terminated 22 Oct 2020

DrugVoluntary: Firm initiated1 product recordHauppauge, NY

InvaGen Pharmaceuticals, Inc. (Hauppauge, NY) initiated this drug recall on 6 Sep 2018; FDA lists 1 product record under event 80973, classified Class III.

FDA defines Class III as a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 22 Oct 2020. Initiation: voluntary: firm initiated. InvaGen Pharmaceuticals, Inc. has 8 enforcement events on this register, with a median of 1 product record per event.

Recall classification reflects the relative degree of health hazard. Text in quotation marks is FDA's. openFDA export dated 28 Sep 2026.

Recalling firm

InvaGen Pharmaceuticals, Inc., Hauppauge, NY.

Reason for recall

"Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size."

Distribution

"Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1212-2018	Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc.…	26,496 bottles	Class III	Terminated	26 Sep 2018

Context

29%of 2018 drug events are Class III367 events that year

1product record in this eventfirm median: 1

8events on this register for the firm

Other enforcement events for 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
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

All 8 events for InvaGen Pharmaceuticals, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size."

What does Class III mean?

FDA classifies recalls by relative degree of health hazard. Class III is a situation in which use of or exposure to a violative product is not likely to cause adverse health consequences.

Where was the product distributed?

FDA's distribution pattern field reads: "Product was distributed to 14 major distributors who shipped the product U.S.A. nationwide."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 Oct 2020. "Terminated" means FDA has determined that all reasonable efforts to remove or correct the product have been made.

Where does this data come from?

openFDA enforcement reports (food, drug and device), CC0, export dated 28 Sep 2026. Text in quotation marks is FDA's. The FDA enforcement report linked above is authoritative.

Provenance

Source: openFDA drug enforcement reports (CC0), export dated 28 Sep 2026; records grouped by FDA event number. The class shown for the event is the most severe class among its records. Errors in processing are corrected at the next build; see corrections.