Drug recall: THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS

Class II FDA enforcement event 87512. Recall start date: 15 Mar 2021. Status in the FDA record: Terminated. Termination date: 17 Jun 2024.

Reason for recall, in the words of FDA

CGMP Deviations: Intermittent exposure to temperature excursion during storage.

Class II, in the words of FDA

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

Cardinal Health Inc. started this drug recall on 15 Mar 2021. The firm address in the FDA record is in Dublin, OH. FDA put the recall in Class II. FDA event 87512 has 198 product records. The first FDA enforcement report date is 2 Jun 2021. The record gives the status Terminated, with the termination date 17 Jun 2024.

FDA enforcement report The 198 product records

It is important to note that most of the time recall classifications are determined after the recalling firm provides all of the information needed to determine the risk posed to public health. The classification and posting in the FDA Enforcement Report should not be seen as an expansion or change to a firm’s voluntary public warning.
FDA publishes these words. Source: FDA, Enforcement Reports, Important Note, read on 1 Oct 2026. openFDA export of 28 Sep 2026.

Distribution

In the words of FDA.

FL, GA, SC

Recalling firm

Cardinal Health Inc., Dublin, OH.

Recalling firm: The firm that the FDA record names for a recall.

FDA records how the recall started: Voluntary: Firm initiated.

Products

198 product records in the event.

FDA event 87512: product records
Recall number	Product	Quantity	Class	Status	Report date
D-0400-2021	THERAPEUTIC M 130; NDC/UPC 740985223680; OTC; TABLETS	55 bottles	Class II	Terminated	2 Jun 2021
D-0401-2021	NIACIN 250MG 110; NDC/UPC 740985228494; OTC; TABLETS	4 bottles	Class II	Terminated	2 Jun 2021
D-0402-2021	Creon (pancrelipase) Delayed-Release Capsules Dose By Lipase Units Lipase 36,000 USP Units Rx only NDC 0032-3016-13 100 Capsules Marketed by: AbbVie Inc. North Chicago, IL 60064, U.S.A.	1669 bottles	Class II	Terminated	2 Jun 2021
D-0403-2021	Orilissa elagolix tablets 150 mg per tablet equivalent to 155.2 mg elagolix sodium, 28 Tablets For 28 Days Rx only NDC 0074-0038-28 Each carton contains 28 tablets in 4 weekly blister pack, Each weekly blister pack contains 7 tablets of elagolix 150 mg AbbVie Inc. North Chicago, IL 60064	210 cartons	Class II	Terminated	2 Jun 2021
D-0404-2021	Norvir Ritonavir Tablets 100 mg 30 Tablets Rx only NDC 0074-3333-30 Abbott Laboratories North Chicago, IL 60064, U.S.A.	362 bottles	Class II	Terminated	2 Jun 2021
D-0405-2021	Synthroid (levothyroxine sodium tablets, USP) in all pack sizes, styles and concentrations Rx only Abbott Laboratories North Chicago, IL	123 bottles	Class II	Terminated	2 Jun 2021
D-0406-2021	METHOCARBAMOL 500MG 500; NDC/UPC 71093014005; RX; TABLETS	51 bottles	Class II	Terminated	2 Jun 2021
D-0407-2021	FENOFIBRATE CAPSULES, UPS 67MG 100 CAPSULES NDC/UPC 27241-118-04; RX; CAPSULES	106 BOXES	Class II	Terminated	2 Jun 2021
D-0408-2021	OFLOXACIN 0.3% 5ML OPTH; NDC/UPC 17478071310; RX; DROPS	339 bottles	Class II	Terminated	2 Jun 2021
D-0409-2021	LIDOCAINE HCL VISC 2% 100ML; NDC/UPC 50383077504; RX; SOLUTION (USUALLY NOT OTIC, OPTH, NASAL DROPS)	240 bottles	Class II	Terminated	2 Jun 2021
D-0410-2021	Atropine Sulfate Ophthalmic Solution, USP 1% For Topical Application To The Eye Sterile 5 mL Rx only NDC 17478-215-05 Manufactured by: Akorn, Inc.	424 bottles	Class II	Terminated	2 Jun 2021
D-0411-2021	COSOPT (Dorzolamide Hydrochloride-Timolol Maleate Ophthalmic Solution) (Dorzolamide Hydrochloride 22.3 mg/mL Timolol Maleate 6.8 mg/mL) 10ML Ocumeter Plus Ophthalmic Dispenser Sterile Ophthlamic Solution Rx only NDC/UPC 174780-605-10 Distributed by: Akorn, Inc. Lake Forest, IL 60045	12 bottles	Class II	Terminated	2 Jun 2021
D-0412-2021	Metoprolol Tartrate and Hydrochlorothiazide Tablets, USP 50 mg/25 mg 100 Tablets Rx only NDC 62332-115-31 Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807 USA	71 bottles	Class II	Terminated	2 Jun 2021
D-0413-2021	BROMFENAC OPHTHALMIC SOLUTION 0.09% 1.7ML NDC/UPC 62332-508-17; RX; DROPS	152 CARTON	Class II	Terminated	2 Jun 2021
D-0414-2021	Vaniqa (eflornithine hydrochloride) Cream, 13.9% For Topical Use Only Net wt. 1.59 oz (45 g) Rx only NDC 0023-4857-45 Manufactured for Allegan, Inc. Irvine, CA 92612	72 tubes	Class II	Terminated	2 Jun 2021
D-0415-2021	UBRELVY 100MG 10UD CPLT; NDC/UPC 23650110; RX; TABLETS	964 bottles	Class II	Terminated	2 Jun 2021
D-0416-2021	RESTASIS 0.05%30X 0.4ML OPTH PF; NDC/UPC 23916330; RX; DROPS/Restasis 0.05% 60x0.4 mL OPTH PF; NDC/UPC 23916330; RX	3688 bottles	Class II	Terminated	2 Jun 2021
D-0417-2021	Linzess (linaclotide) capsules 72 mcg/capsule 30 capsules Rx Only NDC 0456-1203-30 Distributed by: Allergan USA, Inc. Irvine, CA 92612	1529 bottles	Class II	Terminated	2 Jun 2021
D-0418-2021	Namzaric (memantine HCl extended release and donepezil HCl) capsules 14 mg/10 mg per capsule 30 capsules Rx Only NDC 0456-1214-30 Distributed by Forest Pharmaceuticals, Inc. Subsidiary of Forest Laboratories, LLC.	659 bottles	Class II	Terminated	2 Jun 2021
D-0419-2021	Rectiv (nitroglycerin) Ointment 0.4% For Intra-anal Use Only 30 g Rx Only NDC 58914-301-80 Mfd. by: Pharbil Waltrop GmbH, Im Wirrigen 25, 45731 Waltrop, Germany Distributed by: Aptalis Pharma US, Inc. Birmingham, AL 35242	31 tubes	Class II	Terminated	2 Jun 2021
D-0420-2021	Vraylar (cariprazine) capsules in all pack sizes, styles and strengths Rx only Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054	759 bottles	Class II	Terminated	2 Jun 2021
D-0421-2021	Nitrofurantoin Macrocrystals Capsules 25 mg 100 Capsules Rx Only NDC 47781-306-01 Manufactured by: Norwich Pharmaceuticals, Inc. Norwich, NY 13815 Distributed by: Alvogen, Inc. Parsippany, NJ 07054 U.S.A.	15 bottles	Class II	Terminated	2 Jun 2021
D-0422-2021	BUPRENORPHINE AND NALOXONE SUBLINGUAL FILM 4MG/1MG 30 POUCHES EACH CONTAINING 1 SUBLINGUAL FILM NDC/UPC 47781-0356-03; RX; FILM	249 CARTONS	Class II	Terminated	2 Jun 2021
D-0423-2021	Oseltamivir Phosphate for Oral Suspension 6 mg/mL* *Each mL contains 6 mg oseltamivir base after constitution. 60 mL (usable volume after constitution) Rx Only NDC 47781-384-26 Distributed by: Alvogen, Inc. Pine Brook, NJ 07058 USA	15885 bottles	Class II	Terminated	2 Jun 2021
D-0424-2021	ERYTHROMYCIN TABLETS, USP 250MG 30; NDC/UPC 69238-1484-3; RX; TABLETS	135 CARTON	Class II	Terminated	2 Jun 2021
D-0425-2021	TRAVOPROST OPHTHALMIC SOLUTION, USP 0.004% 2.5ML ; NDC/UPC 60505-0593-4; RX; DROPS	325 CARTONS	Class II	Terminated	2 Jun 2021
D-0426-2021	ENOXAPARIN DOFIUM INJRVYION, UPD 150MG/1ML 10X1ML SINGLE DOSE SYRINGES; NDC/UPC 60505-0798-4; RX; SYRINGES	64 BOXES	Class II	Terminated	2 Jun 2021
D-0427-2021	Butorphanol Tartrate Nasal Solution USP 10 mg/mL 2. 5 mL bottles Rx Only NDC 60505-0813-1 Mfg by: Apotex Inc. Toronto, Ontario Canada M9L 1T9	38 bottles	Class II	Terminated	2 Jun 2021
D-0428-2021	Timolol Maleate Ophthalmic Solution, USP 0.5% 2.5 mL Sterile For Topical Application In The Eye Rx Only NDC 60505-1005-4 Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, FL 33326	31 droptainers	Class II	Terminated	2 Jun 2021
D-0429-2021	Edarbi (azilsartan medoxomil) tablets 80 mg 30 Tablets Rx Only NDC 60631-080-30 Manufactured for: arbor Pharmaceuticals Atlanta, GA 30328	328 bottles	Class II	Terminated	2 Jun 2021
D-0430-2021	edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg*/12.5 mg 30 Tablets Rx Only NDC 60631-412-30 Manufactured for: arbor Pharmaceuticals, LLC. Atlanta, GA 30328	244 bottles	Class II	Terminated	2 Jun 2021
D-0431-2021	edarbyclor Azilsartan Medoxomil and Chlorthalidone Tablets 40 mg/25 mg Each tablet contains: 42.68 mg azilsartan kamedoxomil (equivalent to 40 mg azilsartan medoxomil) and 25 mg chlorthalidone. 30 Tablets Rx Only NDC 60631-425-30 Manufactured for Arbor Pharmaceuticals Atlanta, GA 30328	273 bottles	Class II	Terminated	2 Jun 2021
D-0432-2021	GEMCITABINE INJECTION 200MG/5.26ML; NDC/UPC 72485-221-02; RX; SINGLEDOSE VIAL	3 CARTON	Class II	Terminated	2 Jun 2021
D-0433-2021	Brilinta ticagrelar tablets 60 mg 60 tablets Rx only NDC 0186-0776-60 Mfd. for: AstraZeneca LP, Wilmington, DE 19850	1278 bottles	Class II	Terminated	2 Jun 2021
D-0434-2021	Bevespi Aerosphere (glycopyrrolate and formoterol fumarate) Inhalation Aerosol 9 mcg/4.8 mcg per inhalation For Oral Inhalation only 120 inhalations Rx Only NDC 0310-4600-12 Mfd for: AstraZeneca Pharmaceuticals, LP, Wilmington, DE 19850	355 inhalers	Class II	Terminated	2 Jun 2021
D-0435-2021	xigduo XR (dapgliflozin/metformin HCl extended-release) tablets 10 mg/1000 mg 30 Tablets Rx only NDC 0310-6280-30 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850 Manufactured by: Bristol-Myers Squibb Manufacturing Company Humacao, Puerto Rico 00791	664 bottles	Class II	Terminated	2 Jun 2021
D-0436-2021	xigduo XR (dapagliflozin/metformin HCl extended-release) tablets 5 mg/1000 mg 60 Tablets Rx only NDC 0310-6260-60 Manufactured for: AstraZeneca Pharmaceuticals LP Wilmington, DE 19850	378 bottles	Class II	Terminated	2 Jun 2021
D-0437-2021	IBUPROFEN ORAL SUSPENSION USP 100MG/5ML 120ML ; NDC/UPC 59651-032-12; RX; SUSPENSION (NO DROPS)	345 CARTONS	Class II	Terminated	2 Jun 2021
D-0438-2021	Eletriptan Hydrobromide Tablets 20 mg* 6(1x6) Unit-dose Tablets Rx only NDC 59651-104-69 Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Highstown Road East Windsor, NJ 08520	20 CARTONS	Class II	Terminated	2 Jun 2021
D-0439-2021	AMOXICILLIN 500MG 100; NDC/UPC 65862001401; RX; TABLETS	373 bottles	Class II	Terminated	2 Jun 2021
D-0440-2021	ONDANSETRON HCL 4MG 30; NDC/UPC 65862018730; RX; TABLETS	1935 bottles	Class II	Terminated	2 Jun 2021
D-0441-2021	ESZOPICLONE 3MG 100 C4; NDC/UPC 65862096901; RX; TABLETS	29 bottles	Class II	Terminated	2 Jun 2021
D-0442-2021	Nuedexta (dextromethorphan HBr and quinidine sulfate) Capsules 20 mg/10 mg 60 capsules Rx only NDC 64597-301-60 Manufactured by Patheon, Inc. Whitby, ON L1N 5Z5, Canada	255 bottles	Class II	Terminated	2 Jun 2021
D-0443-2021	LOTEMAX SM (loteprednol etabonate ophthalmic gel) 0.38% 5GM; NDC/UPC 24208-0507-07; RX; GEL	463 boxes	Class II	Terminated	2 Jun 2021
D-0444-2021	BENZEFOAM EMOLLIENT FOAM BENZOYL PEROXIDE 5.3% 100GM TOP EMOL NDC 187-0194--10; OTC; FOAMS	2 carton	Class II	Terminated	2 Jun 2021
D-0445-2021	MURO-128 2% 15ML OPTH; NDC/UPC 324208276150; OTC; DROPS	64 droptainers	Class II	Terminated	2 Jun 2021
D-0446-2021	TOBRAMY/DEX 0.3-0.1% 10ML OPTH; NDC/UPC 24208029510; RX; DROPS	47 droptainers	Class II	Terminated	2 Jun 2021
D-0447-2021	DEXAMETH SOD PHOS 0.1% 5ML; NDC/UPC 24208072002; RX; DROPS	318 droptainers	Class II	Terminated	2 Jun 2021
D-0448-2021	Belbuca (buprenorphine hydrochloride) buccal film 300 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-023-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612.	96 cartons	Class II	Terminated	2 Jun 2021
D-0449-2021	Belbuca (buprenorphine hydrochloride) buccal film 600 mcg 60 pouches containing 1 buccal film each Rx only NDC 59385-025-60 Manufactured for: BioDelivery Sciences International, Inc. Raleigh, NC 27612 USA	47 cartons	Class II	Terminated	2 Jun 2021
D-0450-2021	SYMPROIC (NAIDEMEDINE) TABLETS 0.2MG 30 TABLETS; NDC 59385-041-30; RX; TABLETS	67 BOXES	Class II	Terminated	2 Jun 2021
D-0451-2021	NURTEC ODT (RIMEGEPANT) 75MG 8 BPK; NDC/UPC 72618-3000-2; RX; TABLETS FOR RAPID DISSOLUTION (NOT SUBLINGUAL)	1240 CARTON	Class II	Terminated	2 Jun 2021
D-0452-2021	CATAPRES-TTS-2 1X4; NDC/UPC 597003234; RX; ADHESIVE PATCHES	17 patches	Class II	Terminated	2 Jun 2021
D-0453-2021	Spiriva HandiHaler (tiotropium bromide inhalation powder) For Oral Inhalation Only 18 mcg (as tiotropium) per capsule Rx only NDC 0597-0075-41 Manufactured by: Boehringer Ingelheim (BI) Pharma GmbH & Co. KG Ingelheim, Germany Marketed by: Boehringer Ingelheim Pharmaceuticals, Inc. Ridgefield, CT 06877 USA and Pfizer,…	2611 inhalers	Class II	Terminated	2 Jun 2021
D-0454-2021	ATROVENT HFA 17MCG 12.9GM; NDC/UPC 597008717; RX; INHALER MEDICAL INTERNAL - MAY OR MAY NOT BE AEROSOL	667 inhalers	Class II	Terminated	2 Jun 2021
D-0455-2021	Glyxambi (empagliflozin and linagliptin) Tablets 25 mg/5 mg 30 tablets Rx only NDC 0597-0164-30 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA	592 bottles	Class II	Terminated	2 Jun 2021
D-0456-2021	Synjardy (empagliflozin and metformin hydrochloride) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0168-69 Distributed by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA	284 bottles	Class II	Terminated	2 Jun 2021
D-0457-2021	Jentadueto XR (linagliptin and metformin hydrochloride extended-release) Tablets 5 mg/1000 mg 30 tablets Rx only NDC 0597-0275-33 Dist. by: Boehringer Ingleheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA	52 bottles	Class II	Terminated	2 Jun 2021
D-0458-2021	Synjardy XR (empagliflozin and metformin hydrochloride extended-release) Tablets 25 mg/1000 mg 30 tablets Rx only NDC 0597-0295-88 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877 USA	269 bottles	Class II	Terminated	2 Jun 2021
D-0459-2021	Synjardy XR (empagliflozin and metformin) hydrochloride extended-release) Tablets 12.5 mg/1000 mg 60 tablets Rx only NDC 0597-0300-45 Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877 USA	751 bottles	Class II	Terminated	2 Jun 2021

The table shows 60 of 198 product records. The FDA enforcement report lists all the records.

openFDA, about the status: FDA does not update the status of a recall after the recall has been classified according to its level of hazard. As such, the status of a recall (open, completed, or terminated) will remain unchanged after published in the Enforcement Reports. Source: openFDA, Drug Recall Enforcement Reports, Disclaimer.

Enforcement report: The FDA publication that lists recalls. It has one record for each product of a recall.

Enforcement event: All the product records that have one FDA event number. This site shows one event on one page.

Class II: The middle of the three FDA recall classes.

The event in context

Drug events that started in 2021: 299
Share of these events in Class II: 60%
Product records in this event: 198Median of the firm: 3
Events of the firm on the register: 12

Other events of the firm

Other FDA enforcement events of Cardinal Health Inc.
Initiated	Product (first record)	Type	Class	Records
5 Aug 2025	Enoxaparin Sodium Injection, USP, 30 mg/0.3 mL, packaged in 0.3 mL prefilled syringes further packaged in bags of 5 pref	Drug	Class II	1
30 Jul 2025	Xolair (omalizumab injection), 150 mg/ml, 1 auto-injector, Rx only, Genentech, Inc, South San Francisco, CA 9408, NDC: 5	Drug	Class II	3
9 Apr 2025	Wegovy (semaglutide) injection, 2.4 mg/0.75 mL, 4 Single-Dose Prefilled Pens per Carton, For Subcutaneous Use Only, Rx O	Drug	Class II	1
31 Oct 2023	LEADER brand Eye Irritation Relief (Polyvinyl alcohol 0.5%, Povidone 0.6%, Tetrahydrozoline Hydrochloride 0.05%), 0.5 FL	Drug	Class I	6
5 Apr 2022	Humalog KwikPen, Insulin lispro injection, U-100, 100 units per mL, 5x3 mL Prefilled Pens per box, Marketed by Lilly USA	Drug	Class I	3
16 Mar 2021	FREESTYLE LANCETS 28G 100CT Item Number:2975670	Device	Class II	14
9 Mar 2021	Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janss	Drug	Class III	1
20 Apr 2020	B-Hydroxybutyrate LiquiColor, Item code CH2440058 - Product Usage: Product is used for the quantitative determination of	Device	Class II	3
26 Dec 2019	Kangaroo Joey Safety Screw Spike with Flush Bag, Anti-free Flow,1000 mL, Product Code 765100	Device	Class II	6
14 Nov 2019	S.M.A.R.T. Nitinol Stent System and the S.M.A.R.T. Control Nitinol Stent System. The SMART stent system includes a self-	Device	Class II	3

Cardinal Health Inc.: all 12 events

Official channels

FDA enforcement report D-0400-2021The FDA record of the first product of this event.
FDA: recalls, market withdrawals and safety alertsThe recall notices on the FDA site.
FDA MedWatchThe FDA safety reporting program for drugs and medical devices.

Follow by RSS:Food, drug and device recallsFDA Class I recalls

Cite this page

Recall Register. FDA enforcement event 87512. https://recallregister.com/fda/ii/87512/. Source: openFDA enforcement reports. Data through 28 Sep 2026.

Sources

Source: openFDA drug enforcement reports
Licence: CC0 1.0
Export date: 28 Sep 2026
Newest FDA report date on the register: 23 Sep 2026

FDA has one record for each product. This site puts the records with the same event number on one page. The class of the event is the highest class of its records. How the register is made. Report an error.

Questions

Where was the product distributed?: The FDA record gives this distribution: FL, GA, SC
What quantity of product is in FDA event 87512?: The event has 198 product records. The first record gives this quantity: 55 bottles
How did the recall start?: The FDA record says: Voluntary: Firm initiated
How many drug recalls of 2021 have the same class?: 60% of the 299 drug events that started in 2021 are in Class II.