Product Recalls in Colorado

Product recalls affecting Colorado — including food, drugs, consumer products, medical devices, and vehicles distributed to Colorado. RecallDetector monitors distribution data from the FDA, USDA, CPSC, and NHTSA to show you which recalls are relevant to your area. 2,707 recalls have been distributed to Colorado in the last 12 months.

51,434 total recalls
2,707 in last 12 months

Showing 38413860 of 13,494 recalls

DrugAugust 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 1 mg Recalled by Pfizer Inc. Due to CGMP...

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Zydus Pharmaceuticals (USA) Inc

Recalled Item: Carvedilol Tablets Recalled by Zydus Pharmaceuticals (USA) Inc Due to...

The Issue: Presence of Foreign Tablets/Capsules; report of two Paroxetine tablets were...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 0.5mg/1mg Recalled by Pfizer Inc. Due to CGMP...

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Akorn, Inc.

Recalled Item: Betamethasone Dipropionate Lotion USP (Augmented) Recalled by Akorn, Inc....

The Issue: Failed impurities/degradation specification: Out of Specification for an...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 13, 2021· Pfizer Inc.

Recalled Item: Chantix (varenicline) tablets 0.5mg Recalled by Pfizer Inc. Due to CGMP...

The Issue: CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 11, 2021· Ebay Seller - John Nguyen

Recalled Item: Hydro Pinapple Burn Max Health Thach Dua Recalled by Ebay Seller - John...

The Issue: Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugAugust 10, 2021· SterRx, LLC

Recalled Item: Sodium Bicarbonate in 5% Dextrose Injection Recalled by SterRx, LLC Due to...

The Issue: Lack of Assurance of Sterility

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 10, 2021· SterRx, LLC

Recalled Item: Sodium Bicarbonate in 5% Dextrose Injection Recalled by SterRx, LLC Due to...

The Issue: Non-Sterility: firm's third party lab confirmed microbial contamination.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugAugust 6, 2021· XELLIA PHARMACEUTICALS USA, LLC

Recalled Item: Micafungin for Injection Recalled by XELLIA PHARMACEUTICALS USA, LLC Due to...

The Issue: Labeling; Incorrect or Missing Package Insert: The package insert provided...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 6, 2021· XELLIA PHARMACEUTICALS USA, LLC

Recalled Item: Micafungin for Injection Recalled by XELLIA PHARMACEUTICALS USA, LLC Due to...

The Issue: Labeling; Incorrect or Missing Package Insert: The package insert provided...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 5, 2021· Hikma Pharmaceuticals USA Inc.

Recalled Item: Bleomycin for Injection Recalled by Hikma Pharmaceuticals USA Inc. Due to...

The Issue: Labeling: Not elsewhere classified: Mislabeling

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugAugust 5, 2021· DuPont Nutrition USA, Inc

Recalled Item: Avicel Recalled by DuPont Nutrition USA, Inc Due to Out of specification...

The Issue: Out of specification results for conductivity.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class III — Low RiskOngoing
Refund
DrugAugust 3, 2021· Teligent Pharma, Inc.

Recalled Item: Lidocaine Hydrochloride Topical Solution Recalled by Teligent Pharma, Inc....

The Issue: Superpotent Drug

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugAugust 3, 2021· The Harvard Drug Group

Recalled Item: Fexofenadine Hydrochloride Tablets Recalled by The Harvard Drug Group Due to...

The Issue: Failed Impurities/Degradation Specifications

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 2, 2021· Akorn, Inc.

Recalled Item: Artificial Tears Ointment Recalled by Akorn, Inc. Due to Non-Sterility - OOS...

The Issue: Non-Sterility - OOS sterility testing observed during 12-month controlled...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugAugust 2, 2021· Je Dois Lavoir LLC

Recalled Item: 365 SKINNY High Intensity Capsules Recalled by Je Dois Lavoir LLC Due to...

The Issue: Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class I — Serious Health HazardOngoing
Refund
DrugAugust 2, 2021· Macleods Pharma Usa Inc

Recalled Item: Clopidogrel Tablets Recalled by Macleods Pharma Usa Inc Due to Presence of...

The Issue: Presence of foreign matter

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugJuly 30, 2021· Noven Pharmaceuticals Inc

Recalled Item: Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.25 mg...

The Issue: Failed Stability Specifications; out of specification for shear.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugJuly 30, 2021· Noven Pharmaceuticals Inc

Recalled Item: Combipatch (estradiol/norethindrone acetate transdermal system) 0.05/0.14 mg...

The Issue: Failed Stability Specifications; out of specification for shear.

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund
DrugJuly 30, 2021· Custopharm, Inc.

Recalled Item: FLUDARABINE PHOSPHATE FOR INJECTION Recalled by Custopharm, Inc. Due to Lack...

The Issue: Lack of Assurance of Sterility: the manufacturing firm had microbial...

Recommended Action: Stop taking this medication. Contact your pharmacy or healthcare provider.

Class II — Potential Health HazardOngoing
Refund