Food, drugs, devices › Lupin Pharmaceuticals Inc.

Drug recall: Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, In

FDA enforcement event 89324 · Class III · initiated 29 Dec 2021 · status Terminated · terminated 23 Aug 2022

DrugVoluntary: Firm initiated1 product recordBaltimore, MD

FDA enforcement event 89324 is a drug recall by Lupin Pharmaceuticals Inc. of Baltimore, MD, initiated 29 Dec 2021 and classified Class III, with 1 product record.

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. 21% of the 299 drug enforcement events initiated in 2021 carry the same class.

Status: Terminated, terminated 23 Aug 2022. 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

"Out-of-specification impurity test result observed at 18-month long term stability time point."

Distribution

"Product Distributed in NY and OH."

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0358-2022	Oxycodone Hydrochloride Tablets, USP C-II, 5 mg, 100 count bottles, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202. Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-432-01	23,965 100 count bottles	Class III	Terminated	12 Jan 2022

Context

21%of 2021 drug events are Class III299 events that year

1product record 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: "Out-of-specification impurity test result observed at 18-month long term stability time point."

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 Distributed in NY and OH."

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 23 Aug 2022. "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.