Recall Register

Food, drugs, devices › Firms

InvaGen Pharmaceuticals, Inc.

FDA recalling firm · 8 enforcement events · 11 product records · 2018–2023 · NY

InvaGen Pharmaceuticals, Inc. has 8 FDA enforcement events on this register (11 product records) between 2018 and 2023: 8 drug; the busiest year was 2018 with 4.

13% of its events are Class I; the most common class is Class III (6). 0 events are listed as ongoing; the recalling firm's address is in NY.

Recall classification reflects the relative degree of health hazard. Event counts depend on a firm's size and product range; they are not a comparison of one firm with another.

Enforcement events

InitiatedProduct (first record)TypeClassRecordsStatus
17 Nov 2023Vigabatrin for Oral Solution, USP 500 mg per packet, 50 packets per box, Rx Only, Manufactured by: InvaGen Pharmaceuticals, Inc., (a subsidiary of Cipla Ltd.), Hauppauge, NY, 11788, Manufactured for: Cipla USA, Inc., Warren, NJ 07059, NDC 69097-964-53DrugClass I1Completed
14 May 2020Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.DrugClass III1Terminated
12 Jun 2019Testosterone Topical Solution 30mg of testosterone per pump actuation * each actuation delivers 1.5 mL of solution Total contents: 110 mL to deliver 90 mL, Manufactured by: Cipla Ltd, Verna Goa, India Manufactured for: Cipla USA, Inc., Sunrise, FL 33323 NDC 69097-363-44DrugClass III1Terminated
22 Mar 2019Testosterone 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.DrugClass II3Terminated
3 Oct 2018Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15DrugClass III1Terminated
6 Sep 2018Bupropion 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.…DrugClass III1Terminated
15 Mar 2018buPROPion 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 69097-877-03DrugClass III2Terminated
5 Mar 2018Decitabine for Injection, 50mg per vial, Rx only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-285-37DrugClass III1Terminated

By type and class

Drug8
Class III6
Class I1
Class II1

Class I: 13% of this firm's events; 18% of all events on the register.

Events by year

18
19
20
21
22
23
24
25
26
Enforcement events for InvaGen Pharmaceuticals, Inc. by year initiated.

Questions and answers

How many FDA recalls has InvaGen Pharmaceuticals, Inc. had?

8 enforcement events (11 product records) on this register, 2018–2023: 8 drug.

Are any InvaGen Pharmaceuticals, Inc. recalls ongoing?

0 events are listed as ongoing in the current openFDA export.

What class are InvaGen Pharmaceuticals, Inc. recalls?

6 Class III, 1 Class I, 1 Class II. 13% are Class I against 18% of all events on the register. Class reflects the relative degree of health hazard of the product, not the firm.

Where does this data come from?

openFDA food, drug and device enforcement reports (CC0), export dated 28 Sep 2026.

Provenance

Source: openFDA enforcement reports (CC0), export dated 28 Sep 2026. Firm names are grouped exactly as FDA spells them; the same company can appear under several spellings. Only organisations are shown. See the methodology.