Drug recall: Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN

FDA enforcement event 79680 · Class II · initiated 30 Mar 2018 · status Terminated · terminated 4 Jun 2020

DrugVoluntary: Firm initiated1 product recordPulaski, TN

FDA enforcement event 79680 is a drug recall by AVKARE Inc. of Pulaski, TN, initiated 30 Mar 2018 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. 60% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 4 Jun 2020. Initiation: voluntary: firm initiated. AVKARE Inc. has 22 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

AVKARE Inc., Pulaski, TN.

Reason for recall

"Failed Dissolution Specifications"

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-0633-2018	Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only, Manufactured for: AvKARE Inc. Pulaski, TN 38478 --- NDC 50268-069-15	2135 cartons	Class II	Terminated	25 Apr 2018

Context

60%of 2018 drug events are Class II367 events that year

1product record in this eventfirm median: 1

22events on this register for the firm

Other enforcement events for AVKARE Inc.

Initiated	Product (first record)	Type	Class	Records
20 Jul 2022	Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 4229	Drug	Class III	1
9 Jun 2021	Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured for: AvKARE Pulaski, TN 38478. NDC 50268-6	Drug	Class III	1
7 Dec 2020	Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: AvKARE Pulaski, TN 38478, NDC 42291-748-01.	Drug	Class I	2
30 Oct 2020	Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bottle, Rx Only Manufactured for: AvKARE, Inc	Drug	Class II	1
4 Jun 2020	Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC 42291-611-90) b) 180 count (NDC 42291-611-	Drug	Class II	2
28 May 2020	Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-60, b) 500 count Bottle, NDC 42291-368-50,	Drug	Class III	1
7 Jan 2020	Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx Only, Manufactured for: AvKARE, Inc., Pulaski	Drug	Class II	1
14 Nov 2019	AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. Pulaski, TN 38478 Manufactured by: Amneal P	Drug	Class II	2
17 Oct 2019	AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 42291-735-50 UPC 342291735507 Manufactured for:	Drug	Class II	2
28 Aug 2019	AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Tablets per bottle, NDC 42291-297-50.	Drug	Class II	1

All 22 events for AVKARE Inc.

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Dissolution Specifications"

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 4 Jun 2020. "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.