Food, drugs, devices › Heritage Pharmaceuticals, Inc.

Drug recall: Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjaw

FDA enforcement event 81896 · Class II · initiated 2 Jan 2019 · status Terminated · terminated 19 Feb 2021

DrugVoluntary: Firm initiated1 product recordEast Brunswick, NJ

FDA enforcement event 81896 is a drug recall by Heritage Pharmaceuticals, Inc. of East Brunswick, NJ, initiated 2 Jan 2019 and classified Class II, with 1 product record.

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. 68% of the 362 drug enforcement events initiated in 2019 carry the same class.

Status: Terminated, terminated 19 Feb 2021. Initiation: voluntary: firm initiated. Heritage Pharmaceuticals, Inc. has 12 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

Heritage Pharmaceuticals, Inc., East Brunswick, NJ.

Reason for recall

"Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0352-2019	Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjawadi, Pune, India Mfg. for : Heritage Pharmaceuticals Inc. NDC 23155-0216-31	5,060 units	Class II	Terminated	16 Jan 2019

Context

68%of 2019 drug events are Class II362 events that year

1product record in this eventfirm median: 1

12events on this register for the firm

Other enforcement events for Heritage Pharmaceuticals, Inc.

Initiated	Product (first record)	Type	Class	Records
30 Jul 2026	CLINDAMYCIN PALMITATE HYDROCHLORIDE FOR ORAL SOLUTION, USP, 75 mg/5 mL, Rx Only, 100 mL, Distributed by: Avet Pharmaceut	Drug	Class II	1
6 Oct 2025	Desipramine Hydrochloride Tablets, USP, 10 mg, 100 - count bottle (NDC 23155-578-01), Rx only, Manufactured by: USV Priv	Drug	Class II	6
23 Nov 2022	Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed by: Avet Pharmaceuticals Inc. East Brunswick	Drug	Class II	1
21 Apr 2021	Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 0881	Drug	Class III	1
23 Oct 2020	Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.	Drug	Class III	1
21 May 2019	PROCHLORPERAZINE EDISYLATE INJECTION, USP 10 mg/2mL (5mg/mL), 2mL Vial, Rx Only, Mfg by: Emcure Pharmaceuticals Ltd., Hi	Drug	Class I	2
3 May 2019	Losartan Potassium Tablets, USP 50 mg 1000 film coated tablets Rx Only Manufactured by: Vivimed Life Sciences Private Li	Drug	Class II	5
15 Feb 2019	Etomidate Injection, USP 20 mg/10mL (2mg/mL) 10 mL Single-Dose Vial, Rx only, Manufactured for: Heritage Pharmaceuticals	Drug	Class II	1
15 Oct 2018	Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawad	Drug	Class II	1
25 Mar 2015	GLIPIZIDE and METFORMIN HYDROCHLORIDE Tablets, USP, 2.5 mg/500 mg, 100 ct Bottles, Rx Only. Manufactured for: Heritage P	Drug	Class II	1

All 12 events for Heritage Pharmaceuticals, Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Lack of Assurance of Sterility: complaints received about dried powder on the outside of bottle"

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: "Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 19 Feb 2021. "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.