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

Drug recall: Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 bl

FDA enforcement event 63899 · Class I · initiated 14 Dec 2012 · status Terminated · terminated 9 Aug 2016

DrugVoluntary: Firm initiated1 product recordRockford, IL

Mylan Institutional, Inc. (d.b.a. UDL Laboratories) (Rockford, IL) initiated this drug recall on 14 Dec 2012; FDA lists 1 product record under event 63899, classified Class I.

FDA defines Class I as a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death. 15% of the 209 drug enforcement events initiated in 2012 carry the same class.

Status: Terminated, terminated 9 Aug 2016. 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

"Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components."

Distribution

"Nationwide"

Product records

Recall number	Product	Quantity	Class	Status	Report date
D-166-2013	Hydrocodone Bitartrate and Acetaminophen Tablets, USP, 10 mg/500 mg; 100 Tablets (5 x 20), 5 cards each containing 20 blistered tablets per carton, Rx only; Manufactured for: Qualitest Pharmaceuticals, Huntsville, AL 35811, Pkg by &amp; Distributed by UDL Laboratories, Inc., Rockford, IL 61103; NDC 51079-254-21.	3,407 cartons	Class I	Terminated	27 Feb 2013

Context

15%of 2012 drug events are Class I209 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
14 Aug 2018	Diltiazem HCl Extended-release Capsules, USP 120 mg, 80 capsules, 8 blister cards of 10 capsules each per carton, Rx Onl	Drug	Class III	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

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: "Superpotent (Multiple Ingredient) Drug: Oversized tablets resulting in superpotent assays of both the hydrocodone and acetaminophen components."

What does Class I mean?

FDA classifies recalls by relative degree of health hazard. Class I is a situation in which there is a reasonable probability that the use of or exposure to a violative product will cause serious adverse health consequences or death.

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 9 Aug 2016. "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.