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Recall data is sourced from official U.S. government agencies (CPSC, FDA, NHTSA, USDA) and processed using AI to improve readability. This site is not affiliated with or endorsed by any government agency. Always refer to the original agency notice for authoritative information.

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Medium RiskFDA Drug
Medications & Supplements/Prescription Drugs

Various Cardinal Health Drugs Recalled for Temperature Storage Errors

Agency Publication Date: December 26, 2023
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Summary

Cardinal Health is recalling 77 total units of various prescription and over-the-counter medications because they were exposed to temperatures outside of their required storage conditions. The recall affects 42 different products, ranging from asthma inhalers like Albuterol to antibiotics like Amoxicillin and daily medications such as Warfarin and Aspirin. Because these drugs were not kept at the proper temperature, they may have degraded or lost their effectiveness, which means they might not work correctly to treat your medical condition. Consumers should check the specific list of affected brands and lot numbers to see if their medication is involved.

Risk

Exposure to temperatures outside of a product's approved range can cause medications to break down chemically, potentially making them less effective or unstable. This poses a health risk if a patient relies on a full dose of medication for serious conditions like infection, blood clots, or respiratory distress.

What You Should Do

  1. This recall affects dozens of prescription and over-the-counter drug products distributed by Cardinal Health, including brands like Albuterol, Amoxicillin, Jardiance, Spiriva, and Leader Nasal Decongestant.
  2. Check your medication packaging for the specific brand name, dosage strength, and lot number printed on the label or box. See the Affected Products section below for the full list of affected codes.
  3. If you have health concerns, contact your healthcare provider or pharmacist. Return any unused product to the place of purchase for a refund, throw it away, or contact Cardinal Health directly for further instructions.
  4. Call the FDA Consumer Complaint hotline at 1-888-723-3332 (1-888-SAFEFDA) if you have additional questions or wish to report an adverse event.

Your Remedy Options

You have 2 options:

๐Ÿ’ฐOption 1: Full Refund
How to: Contact your healthcare provider or pharmacist for guidance, or return any unused product to the place of purchase for a refund
๐Ÿ—‘๏ธOption 2: Dispose of Product
How to: Throw the product away. For prescription medications, a DEA take-back location or pharmacy mail-back program is preferred when available.

Affected Products

Product: Ipratropium Bromide and Albuterol Sulfate Inhalation Solution (0.5 mg/3 mg per 3 mL)
Variants: 60 x 3 mL Sterile Unit-Dose Vials, Inhalation Solution
Lot Numbers:
21C56
NDC:
69097-840-64

Quantity: 2 cartons

Product: ALBUTEROL SULFATE HFA Inhalation Aerosol (90MCG per actuation)
Variants: 200 Metered Inhalations, Inhalation Aerosol
Lot Numbers:
MY7E
NDC:
66993-019-68

Quantity: 2 cartons

Product: ALBUTEROL SULFATE IN (90MCG per actuation)
Variants: 200 Metered Inhalations, Inhalation Aerosol
Lot Numbers:
K100715
NDC:
68180-963-01

Quantity: 11 cartons

Product: ALLOPURINOL Tablets, USP (300 MG)
Variants: 500 count Tablets per bottle, Tablets
Lot Numbers:
L100813
NDC:
55111-730-05

Quantity: 1 unit

Product: AMOXICILLIN for Oral Suspension USP (400MG/5ML)
Variants: 100ML (when reconstituted), Oral Suspension
Lot Numbers:
35447184A
NDC:
0093-4161-73

Quantity: 3 units

Product: AMOXICILLIN Tablets, USP (875MG)
Variants: 20 Tablets, Tablets
Lot Numbers:
LJ9004
NDC:
0781-5060-20

Quantity: 2 units

Product: Aripiprazole Tablets, USP (5 mg)
Variants: 30 Tablets per bottle, Tablets
Lot Numbers:
AR202318
NDC:
65162-897-03

Quantity: 2 units

Product: ARMOUR THYROID (thyroid tablets, USP) (2 GRAIN (120 mg))
Variants: 100 Tablets, Tablets
Lot Numbers:
W05543
NDC:
0456-0461-01

Quantity: 1 unit

Product: Asmanex Twisthaler (mometasone furoate inhalation powder) (220 mcg per actuation)
Variants: 120 Metered Doses, Inhalation Powder
Lot Numbers:
U027458
NDC:
78206-114-01

Quantity: 3 units

Product: Low Dose ASPIRIN (81 mg)
Variants: 120 Enteric Coated Tablets, Tablets
Lot Numbers:
P126201
NDC:
0536-1234-41

Quantity: 2 units

Product: Bumetanide Tablets, USP (2 mg)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
AM211171

Quantity: 1 unit

Product: CHLORTHALIDONE Tablets, USP (25MG)
Variants: 1000 Tablets, Tablets
Lot Numbers:
2107329UM
NDC:
43598-719-10

Quantity: 1 unit

Product: CITALOPRAM Tablets, USP (20MG)
Variants: 100 Tablets, Tablets
Lot Numbers:
3131748
NDC:
0378-6232-01

Quantity: 1 unit

Product: Colgate Total SF Toothpaste (4.8 oz (136 g))
Variants: Clean Mint, Stannous Fluoride 0.454%
Lot Numbers:
1293US561C

Quantity: 1 unit

Product: Dicyclomine Hydrochloride Tablets, USP (20 mg)
Variants: 100 Tablets, Tablets
Lot Numbers:
3197790
NDC:
0591-0795-01

Quantity: 1 unit

Product: Donepezil HCl Tablets (10 mg)
Variants: 90 Tablets, Tablets
Lot Numbers:
17616
NDC:
43547-276-09

Quantity: 1 unit

Product: Donepezil HCl Tablets (5 mg)
Variants: 90 Tablets, Tablets
Lot Numbers:
17605
NDC:
43547-275-09

Quantity: 1 unit

Product: Doxycycline Capsules, USP (100 mg)
Variants: 50 Capsules, Capsules
Lot Numbers:
G104819
NDC:
68180-652-08

Quantity: 1 unit

Product: Enoxaparin Sodium Injection, USP (150MG/ML)
Variants: Ten 1 mL Single-Dose Syringes per box, Injection
Lot Numbers:
SAH06821A
NDC:
0781-3299-69

Quantity: 2 units

Product: ESTRADIOL TABLETS USP (0.5MG)
Variants: 100 Tablets, Tablets
Lot Numbers:
100023687
NDC:
0555-0899-02

Quantity: 1 unit

Product: FIRST LANSOPRAZOLE PT (3MG/ML)
Variants: 300ML
Lot Numbers:
21025A
NDC:
65628-080-10

Quantity: 1 unit

Product: Fluticasone Propionate Nasal Spray USP (50MCG per spray)
Variants: 16 g net fill weight (120 Metered Sprays), Nasal Spray
Lot Numbers:
TE9159
TE8156
NDC:
60505-0829-1

Quantity: 6 units

Product: FOLIC ACID TABLETS, USP (1MG)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
H08221
NDC:
69315-127-10

Quantity: 1 unit

Product: HydrALAZINE Hydrochloride Tablets, USP (25 mg)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
G210553
G210551
NDC:
23155-002-01

Quantity: 2 units

Product: Jardiance (empagliflozin tablets) (25 mg)
Variants: 30 tablets (3 blister cards), Tablets
Lot Numbers:
D41919
NDC:
0597-0153-37

Quantity: 1 unit

Product: Leader Nasal Decongestant PE (Phenylephrine HCl 10 mg)
Variants: 18 Tablets per carton, Tablets
Lot Numbers:
P125514
NDC:
70000-0126-1

Quantity: 1 unit

Product: Lillow (Levonorgestrel and Ethinyl Estradiol Tablets, USP) (0.15 mg/0.03 mg)
Variants: 1 Blister Pack (28 Tablets), Tablets
Lot Numbers:
A5921
NDC:
69238-1554-6

Quantity: 1 unit

Product: Lisinopril and Hydrochlorothiazide Tablets USP (10mg/12.5mg)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
Q101699
Q101981
NDC:
68180-518-01

Quantity: 2 units

Product: Lithium Carbonate Extended-Release Tablets, USP (300 mg)
Variants: 100 Tablets per bottle, Extended-Release Tablets
Lot Numbers:
3138326
NDC:
0378-1300-01

Quantity: 1 unit

Product: Meloxicam Tablets, USP (15 mg)
Variants: 1000 Tablets per bottle, Tablets
Lot Numbers:
KA11489
NDC:
69097-159-15

Quantity: 1 unit

Product: Metoprolol Succinate Extended-Release Tablets, USP (50 mg)
Variants: 1000 Tablets, Extended-Release Tablets
Lot Numbers:
2447J211
NDC:
45963-676-96

Quantity: 1 unit

Product: Nyamyc (100,000 USP units per gram)
Variants: 60 grams, Topical Powder
Lot Numbers:
400454

Quantity: 2 units

Product: PredniSONE Tablets, USP (20 mg)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
21P0659
NDC:
59746-175-06

Quantity: 1 unit

Product: Propranolol Hydrochloride Tablets (20 mg)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
100023596
NDC:
69238-2078-1

Quantity: 2 units

Product: Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg)
Variants: 10 Drops per roll, Throat Drops
Lot Numbers:
2000058693
NDC:
54305-507-10

Quantity: 2 units

Product: RIVASTIGMINE TRANSDERMAL SYSTEM (4.6 mg/24 hours)
Variants: 30 systems per box, Transdermal Patch
Lot Numbers:
P0248AL0AT
NDC:
47781-304-03

Quantity: 1 unit

Product: SPIRIVA HANDIHALER (tiotropium bromide inhalation powder) (18 mcg/Capsule)
Variants: 30 capsules (3 blister cards), Inhalation Powder
Lot Numbers:
104440
NDC:
0597-0075-41

Quantity: 5 units

Product: Terconazole Vaginal Suppositories (80 mg)
Variants: 3 Suppositories with Vaginal Applicator, Vaginal Suppositories
Lot Numbers:
1014228A
NDC:
0713-0552-73

Quantity: 1 unit

Product: Triamterene and Hydrochlorothiazide Capsules, USP (37.5 mg/25 mg)
Variants: 100 capsules per bottle, Capsules
Lot Numbers:
21000279A
21000280A
NDC:
0527-1632-01

Quantity: 2 units

Product: Warfarin Sodium Tablets, USP (2.5 mg)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
2169041
NDC:
0093-1714-01

Quantity: 1 unit

Product: Warfarin Sodium Tablets, USP (5 mg)
Variants: 100 Tablets per bottle, Tablets
Lot Numbers:
2323041
NDC:
0093-1721-01

Quantity: 1 unit

Product: Inhub Wixela (fluticasone propionate and salmeterol inhalation powder, USP) (500/50MCG)
Variants: 60 Doses, Inhalation Powder
Lot Numbers:
62002532
NDC:
0378-9320-32

Quantity: 1 unit

Additional Information

Agency: Food and Drug Administration (FDA)
Event ID: 89450
Status: Resolved
Manufacturer: CARDINAL HEALTHCARE
Sold By: Cardinal Health; Retail Pharmacies
Manufactured In: United States, India, Canada, Singapore, Switzerland
Units Affected: 42 products (2 cartons; 2 cartons; 11 cartons; 1 unit; 3 units; 2 units; 2 units; 1 unit; 3 units; 2 units; 1 unit; 1 unit; 1 unit; 1 unit; 1 unit; 1 unit; 1 unit; 1 unit; 2 units; 1 unit; 1 unit; 6 units; 1 unit; 2 units; 1 unit; 1 unit; 1 unit; 2 units; 1 unit; 1 unit; 1 unit; 2 units; 1 unit; 2 units; 2 units; 1 unit; 5 units; 1 unit; 2 units; 1 unit; 1 unit; 1 unit)
Distributed To: Nationwide

Were You Affected by This Recall?

If you or a family member were harmed by this recalled product, you may have legal rights. Consider consulting a consumer protection attorney to understand your options for compensation.

Find an Attorney

This is general information, not legal advice. Go Backs is not a law firm and does not provide legal services.

AI-Enhanced Content: The summary, action steps, and risk assessment on this page were generated by AI from official government recall data to improve readability. This is not legal or medical advice. Always refer to the official agency sources below for authoritative information.

Sources: FDA iRES ยท Raw API Response

openFDA Disclaimer: This recall information is sourced from the openFDA API. Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. Refer to the openFDA terms of service for more information.