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 37013720 of 13,494 recalls

DrugOctober 13, 2021· Ultra Seal Corporation

Recalled Item: PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets...

The Issue: Failed Stability Specifications: Out-of-Specification results observed for...

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

Class III — Low RiskOngoing
Refund
DrugOctober 13, 2021· Ultra Seal Corporation

Recalled Item: Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin...

The Issue: Failed Stability Specifications: Out-of-Specification results observed for...

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

Class III — Low RiskOngoing
Refund
DrugOctober 13, 2021· Ultra Seal Corporation

Recalled Item: Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65...

The Issue: Failed Stability Specifications: Out-of-Specification results observed for...

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

Class III — Low RiskOngoing
Refund
DrugOctober 13, 2021· Ultra Seal Corporation

Recalled Item: North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg...

The Issue: Failed Stability Specifications: Out-of-Specification results observed for...

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

Class III — Low RiskOngoing
Refund
DrugOctober 13, 2021· Ultra Seal Corporation

Recalled Item: AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65...

The Issue: Failed Stability Specifications: Out-of-Specification results observed for...

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

Class III — Low RiskOngoing
Refund
DrugOctober 12, 2021· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine...

The Issue: Failed Moisture Limits

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

Class III — Low RiskOngoing
Refund
DrugOctober 12, 2021· Lupin Pharmaceuticals Inc.

Recalled Item: Irbesartan Tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to CGMP...

The Issue: CGMP Deviations: impurity N-nitrosoirbesartan detected in API

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 12, 2021· Lupin Pharmaceuticals Inc.

Recalled Item: Irbesartan Tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to CGMP...

The Issue: CGMP Deviations: impurity N-nitrosoirbesartan detected in API

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 12, 2021· Lupin Pharmaceuticals Inc.

Recalled Item: Irbesartan and Hydrochlorothiazide Tablets USP Recalled by Lupin...

The Issue: CGMP Deviations: impurity N-nitrosoirbesartan detected in API

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 12, 2021· Teligent Pharma, Inc.

Recalled Item: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Recalled by...

The Issue: Superpotent Drug

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

Class I — Serious Health HazardOngoing
Refund
DrugOctober 12, 2021· Lupin Pharmaceuticals Inc.

Recalled Item: Irbesartan Tablets USP Recalled by Lupin Pharmaceuticals Inc. Due to CGMP...

The Issue: CGMP Deviations: impurity N-nitrosoirbesartan detected in API

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 12, 2021· SUN PHARMACEUTICAL INDUSTRIES INC

Recalled Item: AllerClear D-24 hr Recalled by SUN PHARMACEUTICAL INDUSTRIES INC Due to...

The Issue: Failed Moisture Limits

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

Class III — Low RiskOngoing
Refund
DrugOctober 12, 2021· Teligent Pharma, Inc.

Recalled Item: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Recalled by...

The Issue: CGMP Deviations: Lots recalled because they were manufactured at the same...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 12, 2021· Teligent Pharma, Inc.

Recalled Item: Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL) Recalled by...

The Issue: CGMP Deviations: Lots recalled because they were manufactured at the same...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 12, 2021· Lupin Pharmaceuticals Inc.

Recalled Item: Irbesartan and Hydrochlorothiazide Tablets USP Recalled by Lupin...

The Issue: CGMP Deviations: impurity N-nitrosoirbesartan detected in API

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 12, 2021· Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals

Recalled Item: Methocarbamol 500mg Tablet Recalled by Bryant Ranch Prepack, Inc. dba BRP...

The Issue: Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol...

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

Class I — Serious Health HazardOngoing
Refund
DrugOctober 8, 2021· Lupin Pharmaceuticals Inc.

Recalled Item: Imipramine Pamoate Capsules 125 mg Recalled by Lupin Pharmaceuticals Inc....

The Issue: Out of specification result observed in a dissolution test at the 9-month...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 5, 2021· Dr. Reddy's Laboratories, Inc.

Recalled Item: Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled by Dr. Reddy's...

The Issue: Failed Excipient Specifications; product manufactured using an excipient...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 5, 2021· Dr. Reddy's Laboratories, Inc.

Recalled Item: Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled by Dr. Reddy's...

The Issue: Failed Excipient Specifications; product manufactured using an excipient...

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

Class II — Potential Health HazardOngoing
Refund
DrugOctober 5, 2021· Dr. Reddy's Laboratories, Inc.

Recalled Item: Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled by Dr. Reddy's...

The Issue: Failed Excipient Specifications; product manufactured using an excipient...

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

Class II — Potential Health HazardOngoing
Refund