Food, drugs, devices › Heritage Pharmaceuticals Inc

Drug recall: Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc.

FDA enforcement event 86659 · Class III · initiated 23 Oct 2020 · status Terminated · terminated 28 Jan 2022

DrugVoluntary: Firm initiated1 product recordEast Brunswick, NJ

FDA enforcement event 86659 is a drug recall by Heritage Pharmaceuticals Inc of East Brunswick, NJ, initiated 23 Oct 2020 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 342 drug enforcement events initiated in 2020 carry the same class.

Status: Terminated, terminated 28 Jan 2022. 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

"Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A"

Distribution

"USA Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0108-2021	Felodipine Extended Release Tablets, USP 10 mg,100-count bottle, Rx only, Distributed by: Heritage Pharmaceuticals Inc. East Brunswick, NJ 08816 Made in India, NDC 23155-050-01	7176 bottles	Class III	Terminated	2 Dec 2020

Context

21%of 2020 drug events are Class III342 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
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
2 Jan 2019	Cidofovir Injection 375mg/5mL (75mg/mL) vial injection. 5 mL vials, Rx only, Mfd by: Emcure Pharmaceuticals Ltd., Hinjaw	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: "Failed impurities/ degradation specifications: Out of specification impurity results were observed during routine testing of stability samples for the impurity Felodipine Related compound A"

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: "USA Nationwide"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 28 Jan 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.