Food, drugs, devices › Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Drug recall: Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Onl

FDA enforcement event 80802 · Class III · initiated 14 Aug 2018 · status Terminated · terminated 26 Jun 2020

DrugVoluntary: Firm initiated1 product recordRockford, IL

FDA enforcement event 80802 is a drug recall by Mylan Institutional, Inc. (d.b.a. UDL Laboratories) of Rockford, IL, initiated 14 Aug 2018 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. 29% of the 367 drug enforcement events initiated in 2018 carry the same class.

Status: Terminated, terminated 26 Jun 2020. Initiation: voluntary: firm initiated. Mylan Institutional, Inc. (d.b.a. UDL Laboratories) has 16 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

Mylan Institutional, Inc. (d.b.a. UDL Laboratories), Rockford, IL.

Reason for recall

"Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer"

Distribution

"Nationwide USA"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-1112-2018	Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV. NDC 51079-947-08	408 cartons	Class III	Terminated	29 Aug 2018

Context

29%of 2018 drug events are Class III367 events that year

1product record in this eventfirm median: 1

16events on this register for the firm

Other enforcement events for Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Initiated	Product (first record)	Type	Class	Records
1 Apr 2022	Esomeprazole Magnesium Delayed-Release Capsules, USP 20 mg, packaged in Unit Dose Blister Cards of 6 (10 cards of 6 Caps	Drug	Class II	2
18 Jan 2019	Alprazolam Tablets, USP, 0.25 mg, 10x10 per carton, Rx Only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, W	Drug	Class II	1
1 May 2018	Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Manufactured by Mylan Pharmaceuticals Inc. Mo	Drug	Class II	2
21 Mar 2017	Atorvastatin Calcium Tablets, 10 mg*, 100-count Unit Dose Tablets (10 x 10) per carton, Rx only, Manufactured by: Mylan	Drug	Class II	1
27 Jan 2017	Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactured by: Mylan Pharmaceuticals Inc, Morgantown,	Drug	Class II	1
28 Sep 2016	Clonazepam Tablets, USP, 0.5 mg, packaged in a)100- count unit dose box of 10 x 10 blister cards (NDC 51079-881-20) and	Drug	Class III	2
28 Jan 2016	Clonazepam Tablets, USP, 0.5 mg, 100-count carton, Rx only, Manufactured by Mylan Pharmaceuticals Inc., Morgantown, WV,	Drug	Class III	1
2 Nov 2015	Meclizine Hydrochloride Tablets, USP, 25 mg Tablets, Packaged in 10 x 10 Tablet Blister Pack Packages, Rx Only. Manufact	Drug	Class III	1
26 Mar 2015	Fexofenadine Hydrochloride Tablets, USP 60 mg, Allergy, Non-Drowsy, Antihistamine, 100 tablets (10 X 10) per UD Cartons,	Drug	Class III	1
3 Jul 2014	Diltiazem HCl Extended-release Capsules, USP, 120 mg, packaged in 80 Capsules (8 x 10) blister cards per carton, Rx only	Drug	Class III	1

All 16 events for Mylan Institutional, Inc. (d.b.a. UDL Laboratories)

Questions and answers

Why was this drug recalled?

FDA's record gives the reason for recall as: "Failed Impurities/Degradation Specifications; out of specification results for related compound per the manufacturer"

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: "Nationwide USA"

Is the recall still ongoing?

FDA lists the status as Terminated; the termination date is 26 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.