Food, drugs, devices › Lupin Pharmaceuticals Inc.

Drug recall: Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmac

FDA enforcement event 67462 · Class III · initiated 27 Jan 2014 · status Terminated · terminated 12 May 2015

DrugVoluntary: Firm initiated2 product recordsBaltimore, MD

Lupin Pharmaceuticals Inc. (Baltimore, MD) initiated this drug recall on 27 Jan 2014; FDA lists 2 product records under event 67462, 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. 27% of the 313 drug enforcement events initiated in 2014 carry the same class.

Status: Terminated, terminated 12 May 2015. Initiation: voluntary: firm initiated. Lupin Pharmaceuticals Inc. has 91 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

Lupin Pharmaceuticals Inc., Baltimore, MD.

Reason for recall

"Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1186-2014	Suprax, Cefixime for Oral Suspension USP 500 mg/5 ml, 10mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-02.	4,038 bottles	Class III	Terminated	9 Apr 2014
D-1187-2014	Suprax, Cefixime for Oral Suspension USP, 500 mg/5 ml, 20 mL (when reconstituted), Rx only, Manufactured for Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, MD 21202, Manufactured by Lupin Limited Mumbai 400 058 India, NDC 27437-207-03.	5,172 bottles	Class III	Terminated	9 Apr 2014

Context

27%of 2014 drug events are Class III313 events that year

2product records in this eventfirm median: 1

91events on this register for the firm

Other enforcement events for Lupin Pharmaceuticals Inc.

Initiated	Product (first record)	Type	Class	Records
3 Aug 2026	Clobetasol Propionate Cream USP, 0.05%, 60 g tube, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34	Drug	Class II	1
23 Jun 2026	Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection USP, 1mg per vial, Diluent for Glucagon, 1 mL syringe	Drug	Class II	1
4 Jun 2026	prednisoLONE Acetate Ophthalmic Suspension, USP, 1%, Rx only, Sterile, a) 5 mL (NDC 70748-332-02); b) 10 mL (NDC 70748-3	Drug	Class II	1
24 Apr 2026	Liraglutide Injection, 18 mg/3 mL (6 mg/mL), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Naples, FL 34108, M	Drug	Class II	1
13 Nov 2025	Ganirelix Acetate Injection, 250 mcg/0.5mL, Single-dose Sterile Prefilled Syringe, 27 gauge by 1/2' needle, Rx only, Man	Drug	Class II	1
5 Nov 2025	Sertraline Hydrochloride Tablets USP, 100 mg, 90 Tablets bottles, Rx Only, Manufactured by: Lupin Pharmaceuticals, Inc.,	Drug	Class II	1
2 Jul 2025	Amlodipine and Benazepril HCl Capsules USP 2.5 mg/10 mg, 100 Capsules bottle, Rx Only, Manufactured for: Lupin Pharmaceu	Drug	Class II	1
27 Jun 2025	clomiPRAMINE Hydrochloride Capsules USP 25 mg, 100 count bottles, 5801 Pelican Bay Boulevard, Suite 500, Naples, Florida	Drug	Class II	1
20 Jun 2025	Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles, Rx only, Mfg for: Lupin Pharmaceuticals,	Drug	Class II	1
10 Apr 2025	clomiPRAMINE hydrochloride Capsules USP, 25 mg, 100-count bottle, Rx only, Manufactured For: Lupin Pharmaceuticals, Inc.	Drug	Class II	1

All 91 events for Lupin Pharmaceuticals Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications: Product did not meet specification in total impurities at the 9-month stability station."

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: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 12 May 2015. "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.