Food, drugs, devices › Lupin Pharmaceuticals Inc.

Drug recall: Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09

FDA enforcement event 89916 · Class II · initiated 31 Mar 2022 · status Terminated · terminated 22 May 2023

DrugVoluntary: Firm initiated6 product recordsBaltimore, MD

Lupin Pharmaceuticals Inc. (Baltimore, MD) initiated this drug recall on 31 Mar 2022; FDA lists 6 product records under event 89916, classified Class II.

FDA defines Class II as a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote. 65% of the 325 drug enforcement events initiated in 2022 carry the same class.

Status: Terminated, terminated 22 May 2023. 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

"CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits"

Distribution

"Product was distributed nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0838-2022	Losartan Potassium Tablets USP, 25 mg, a) 90-count bottles (NDC# 68180-376-03), b) 1000-count bottles (NDC# 68180-376-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.	657,336 bottles	Class II	Terminated	11 May 2022
D-0839-2022	Losartan Potassium Tablets USP, 50 mg, a) 90-count bottles (NDC# 68180-377-03), b) 1000-count bottles (NDC# 68180-377-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.	1,466,150 bottles	Class II	Terminated	11 May 2022
D-0840-2022	Losartan Potassium Tablets USP, 100 mg, a) 90-count bottles (NDC# 68180-378-03), b) 1000-count bottles (NDC# 68180-378-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.	1,247,067 bottles	Class II	Terminated	11 May 2022
D-0841-2022	Losartan Potassium and Hydrochlorothiazide Tablets USP, 50 mg/12.5 mg a) 30-count bottles (NDC# 68180-215-06) b) 90-count bottles (NDC# 68180-215-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA.	1,214,016 bottles	Class II	Terminated	11 May 2022
D-0842-2022	Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/25 mg a) 30-count bottles (NDC# 68180-217-06) b) 90-count bottles (NDC# 68180-217-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA	303,696 bottles	Class II	Terminated	11 May 2022
D-0843-2022	Losartan Potassium and Hydrochlorothiazide Tablets USP, 100 mg/12.5 mg a) 30-count bottles (NDC# 68180-216-06) b) 90-count bottles (NDC# 68180-216-09), Rx Only, Manufactured By: Lupin Limited, Pithampur, India, MFG For: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202, USA	2,361,924 bottles	Class II	Terminated	11 May 2022

Context

65%of 2022 drug events are Class II325 events that year

6product 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: "CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits"

What does Class II mean?

FDA classifies recalls by relative degree of health hazard. Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences or where the probability of serious adverse health consequences is remote.

Where was the product distributed?

FDA's distribution pattern field reads: "Product was distributed nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 22 May 2023. "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.