CARDINAL HEALTHCARE: 42 FDA recall reports
Every drug recall the FDA has published for CARDINAL HEALTHCARE. The fault, and how the agency graded it.
42Reports
0Class I
0Ongoing
2024-01-03Most recent
What the classes mean
The FDA sorts every recall into one of three classes. The class is the whole story. It is also the part people skip.
Class II is the bulk of every list here. That matters. A long list of Class II says something different from one Class I.
By class
Checking whether it affects you
The lot or code number is what matters. Not the product name. A recall covers
specific lots. Yours may not be one of them.
Check the code on your package against the report. The FDA keeps the current
list at fda.gov/safety/recalls.
The reports
The text below is quoted from the FDA record word for word.
Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous
D-0179-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automatic Safety Device, For Subcutaneous Injection, Ten 1 mL Syringes per box, Rx Only, Sandoz Inc, Princeton, NJ 08540. NDC: 0781-3299-69
- Where it went
- Nationwide USA
- How much
- 2 units
RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvoge
D-0196-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box, Rx Only, Distributed by: Alvogen, Inc., Morristown, NJ 07960. NDC 47781-304-03
- Where it went
- Nationwide USA
- How much
- 1 unit
ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, IN
D-0168-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only, Distributed by: Allergan US, INc., Madison, NJ 07940. NDC: 0456-0461-01
- Where it went
- Nationwide USA
- How much
- 1 unit
Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto
D-0177-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-275-09
- Where it went
- Nationwide USA
- How much
- 1 unit
SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each c
D-0197-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) 18 mcg/Capsule, 30 capsules, 3 blister cards, each card contains 10 capsules, Rx only, For oral inhalation only, Distributed by: Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT 06877 USA. NDC: 0597-0075-41
- Where it went
- Nationwide USA
- How much
- 5 units
Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, P
D-0201-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Warfarin Sodium Tablets, USP, 5 mg, 100 Tablets per bottle, Rx Only, Manufactured for: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1721-01
- Where it went
- Nationwide USA
- How much
- 1 unit
Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distribut
D-0199-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Triamterene and Hydrochlorothiazide Capsules, USP, 37.5 mg/25 mg, 100 capsules per bottle, Rx Only, Distributed by: Lannett Company, Inc, Philadelphia, PA 19136. NDC 0527-1632-01
- Where it went
- Nationwide USA
- How much
- 2 units
Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health
D-0186-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg), 18 Tablets per cartons, Distributed By Cardinal Health, Dublin, Ohio 43017. NDC: 70000-0126-1
- Where it went
- Nationwide USA
- How much
- 1 unit
FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 6562
D-0181-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- FIRST LANSOPRAZOLE PT 3MG/ML, 300ML, Rx Only, Distributed By: CutisPharma, Inc., Woburn, MA 01801. NDC: 65628-080-10
- Where it went
- Nationwide USA
- How much
- 1 unit
Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto
D-0176-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Donepezil HCl Tablets, 10 mg, 90 Tablets, Rx only, Distributed by: Solco Healthcare U.S. LLC, Hurracao, Puerto Rico 00791. NDC: 43547-276-09
- Where it went
- Nationwide USA
- How much
- 1 unit
Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park D
D-0170-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Low Dose ASPIRIN, 81 mg, 120 Enteric Coated Tablets, Distributed by: Rugby Lavoratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1234-41
- Where it went
- Nationwide USA
- How much
- 2 units
Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. L
D-0171-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Bumetanide Tablets, USP, 2 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213 India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807
- Where it went
- Nationwide USA
- How much
- 1 unit
Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals,
D-0200-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Warfarin Sodium Tablets, USP, 2.5 mg, 100 Tablets per bottle, Rx only, Manufactured For: Teva Pharmaceuticals, Parsippany, NJ 07054. NDC: 0093-1714-01
- Where it went
- Nationwide USA
- How much
- 1 unit
ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC
D-0180-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- ESTRADIOL TABLETS USP, 0.5MG 100 Tablets, Tx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 0555-0899-02
- Where it went
- Nationwide USA
- How much
- 1 unit
Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimo
D-0178-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Doxycycline Capsules, USP 100 mg, 50 Capsules, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202 Unite States; Manufactured by: Lupin Limited, Nagpur - 441 108, INDIA. NDC 68180-652-08
- Where it went
- Nationwide USA
- How much
- 1 unit
Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation
D-0202-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) 500/50MCG, 60 Doses of Inhalation Powder, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-9320-32
- Where it went
- Nationwide USA
- How much
- 1 unit
Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intrana
D-0182-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Fluticasone Propionate Nasal Spray USP, 50MCG per spray, 16 g net fill weight, 120 Metered Sprays, For Intranasal Use Only, Rx Only, Manufactured for: Apotext Corp., Weston, FL 33326. NDC: 60505-0829-1
- Where it went
- Nationwide USA
- How much
- 6 units
Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured fo
D-0188-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Lisinopril and Hydrochlorothiazide Tablets USP, 10mg/12.5mg, Rx only, 100 Tablets per bottles, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Nagpur-441 108, India. NDC: 68180-518-01
- Where it went
- Nationwide USA
- How much
- 2 units
Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by:
D-0198-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Terconazole Vaginal Suppositories, 80 mg, 3 Suppositories with Vaginal Applicator, Rx only, Manufactured by: Cosette Pharmaceuticals, Inc., 111 Coolidge Street, South Plainfield, NJ 07080. NDC: 0713-0552-73
- Where it went
- Nationwide USA
- How much
- 1 unit
Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: My
D-0189-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Lithium Carbonate Extended-Release Tablets, USP, 300 mg, 100 Tablets per bottle, Rx only, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505. NDC: 0378-1300-01
- Where it went
- Nationwide USA
- How much
- 1 unit
Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Labora
D-0192-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Nyamyc, 100,000 USP units per gram, 60 grams, Rx only, Topical Use Only, Manufactured by: Upsher-Smith Laboratories, Inc, Minneapolis, MN 55447.
- Where it went
- Nationwide USA
- How much
- 2 units
HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceu
D-0184-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- HydrALAZINE Hydrochloride Tablets, USP, 25 mg, 100 Tablets per bottle, Rx only, Distributed by: Avet Pharmaceuticals Inc., East Brunswick, NJ 08816. NDC: 23155-002-01
- Where it went
- Nationwide USA
- How much
- 2 units
Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PA
D-0174-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Colgate Total SF Toothpaste, Net Wt 4.8 oz (136 g), Stannous Fluoride 0.454%, Clean Mint, Dist. by: COLGATE-PALMOLIVE CO., New York, NY 10022 USA
- Where it went
- Nationwide USA
- How much
- 1 unit
Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewate
D-0167-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Aripiprazole Tablets, USP, 5 mg, 30 Tablets per bottle, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 65162-897-03
- Where it went
- Nationwide USA
- How much
- 2 units
PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuti
D-0193-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- PredniSONE Tablets, USP, 20 mg, 100 Tablets per bottle, Rx Only, Manufactured by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801. NDC: 59746-175-06
- Where it went
- Nationwide USA
- How much
- 1 unit
Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, In
D-0191-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Metoprolol Succinate Extended-Release Tablets, USP, 50 mg, 1000 Tablets, Rx Only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454. NDC: 45963-676-96
- Where it went
- Nationwide USA
- How much
- 1 unit
Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tabl
D-0187-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP), 0.15 mg/0.03 mg, 1 Blister Pack Containing 28 Tablets, Rx only, Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC 69238-1554-6
- Where it went
- Nationwide USA
- How much
- 1 unit
Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuti
D-0194-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd., Ahmedabad 382213, India; Distributed by: Amneal Pharmaceuticals LLC, Bridgewater, NJ 08807. NDC: 69238-2078-1
- Where it went
- Nationwide USA
- How much
- 2 units
ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratori
D-0164-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufactured By: Dr. Reddy's Laboratories LA LLC, Shreveport, LA 71106. NDC: 55111-730-05
- Where it went
- Nationwide USA
- How much
- 1 unit
AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton,
D-0166-2024 · Class II · reported 2024-01-03 · Terminated
- Why it was recalled
- CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage conditions.
- Product
- AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz GmbH for Sandoz Inc., Princeton, NJ 08540. NDC: 0781-5060-20
- Where it went
- Nationwide USA
- How much
- 2 units
Showing the 30 most recent of 42. The rest are searchable at the FDA enforcement report database.
Read these counts with three things in mind
A firm with more recalls usually makes more products. A contract packer runs
hundreds of lines. It will out-recall a company with one product whatever either
does. This is not a safety ranking.
Most recalls here are voluntary. A firm found its own fault and pulled the stock.
That is the system working. It lands in this database looking the same as a recall
the FDA had to push for.
Terminated means the FDA considers the recall finished. It is not a verdict.
It does not mean anyone was harmed.
Source: openFDA enforcement reports, retrieved 2026-08-05. FDA dataset last updated 2026-07-29.
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