Drug Recalls

Here you'll find every drug recall the FDA has issued, including prescription medications, over-the-counter drugs, compounded pharmacy products, and dietary supplements. We've been tracking these since 2006 and our database updates several times a day so you're always looking at current information.

Drugs get recalled for a number of reasons: contamination during manufacturing, incorrect potency or dosage, failed quality testing (like dissolution or stability tests), sterility problems in injectable products, or labeling and packaging errors that could cause someone to take the wrong dose. If you find a product on this list that you use, please follow the instructions provided by the FDA to take the necessary precautions.

17,529 total recalls
1 this month

Showing 7901–7920 of 17,529 recalls

December 11, 2018· Asclemed USA Inc. dba Enovachem

Recalled Item: Dyural-80 Injection Kit

The Issue: Labeling: Not eslewhere classified - The kits include

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

Class I — Serious Health HazardTerminated
Refund
December 11, 2018· KVK-Tech, Inc.

Recalled Item: Oxybutynin Chloride Tablets

The Issue: Labeling: Wrong bar code

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

Class II — Potential Health HazardTerminated
Refund
December 10, 2018· CBI Laboratories, Inc.

Recalled Item: Advanced Protection Sunscreen spf 30 (Octinoxate 7.5%

The Issue: Subpotent Drug:Out of specification for percentage of active

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

Class III — Low RiskTerminated
Refund
December 10, 2018· CBI Laboratories, Inc.

Recalled Item: Options Rx Anti-Oxidant Oil-Free Sunscreeen (Octinoxate 7.5%

The Issue: Subpotent Drug:Out of specification for percentage of active

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

Class III — Low RiskTerminated
Refund
December 10, 2018· Gordon Laboratories

Recalled Item: Monsel's (Ferric Subsulfate) Solution

The Issue: Superpotent Drug: contains higher levels of Iron than

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

Class II — Potential Health HazardTerminated
Refund
December 10, 2018· Dr. Reddy's Laboratories, Inc.

Recalled Item: Clopidogrel Tablets

The Issue: Failed dissolution specification -Two additional lots being recalled

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

Class II — Potential Health HazardTerminated
Refund
December 7, 2018· US Pharmaceuticals Inc.

Recalled Item: Soothe & Cool Protect Moisture Guard Skin Protectant (petrolatum 59%)

The Issue: GMP Deviations: Out of specification results for Total

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

Class II — Potential Health HazardTerminated
Refund
December 7, 2018· US Pharmaceuticals Inc.

Recalled Item: Medline Remedy Essential Barrier Skin Protectant Ointment (petrolatum 59%)...

The Issue: GMP Deviations: Out of specification results for Total

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

Class II — Potential Health HazardTerminated
Refund
December 7, 2018· US Pharmaceuticals Inc.

Recalled Item: Hydrocortisone Cream 1% MS Anti itch Cream with Intensive Healing 2 oz tubes

The Issue: GMP Deviations: Out of specification results for Total

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

Class II — Potential Health HazardTerminated
Refund
December 7, 2018· Sun Pharmaceutical Industries, Inc.

Recalled Item: Absorica (Isotretinoin) Capsules 30 mg USP

The Issue: Subpotent Drug: Isotretinoin content results were lower than

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

Class III — Low RiskTerminated
Refund
December 6, 2018· Pfizer Inc.

Recalled Item: Levoxyl (levothyroxine sodium tablets

The Issue: Superpotent Drug

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

Class II — Potential Health HazardTerminated
Refund
December 5, 2018· Pharmedium Services, LLC

Recalled Item: Fentanyl Citrate 2 mcg per mL (200 mcg per 100

The Issue: Sub-potent

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

Class II — Potential Health HazardTerminated
Refund
December 5, 2018· Pharmedium Services, LLC

Recalled Item: Fentanyl Citrate 2 mcg per mL (100 mcg per 50

The Issue: Sub-potent

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

Class II — Potential Health HazardTerminated
Refund
December 4, 2018· Epic Pharma, LLC

Recalled Item: Estradiol Tablets

The Issue: Presence of foreign tablet/capsule: A single foreign tablet

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

Class II — Potential Health HazardTerminated
Refund
December 4, 2018· Mylan Laboratories Limited, (Nashik FDF)

Recalled Item: Valsartan and Hydrochlorothiazide Tablets

The Issue: GCMP Deviations: FDA analysis confirmed presence of trace

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

Class II — Potential Health HazardOngoing
Refund
December 4, 2018· Mylan Laboratories Limited, (Nashik FDF)

Recalled Item: Valsartan and Hydrochlorothiazide Tablets

The Issue: GCMP Deviations: FDA analysis confirmed presence of trace

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

Class II — Potential Health HazardOngoing
Refund
December 4, 2018· Mylan Laboratories Limited, (Nashik FDF)

Recalled Item: Valsartan and Hydrochlorothiazide Tablets

The Issue: GCMP Deviations: FDA analysis confirmed presence of trace

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

Class II — Potential Health HazardOngoing
Refund
December 4, 2018· Mylan Laboratories Limited, (Nashik FDF)

Recalled Item: Valsartan Tablets

The Issue: GCMP Deviations: FDA analysis confirmed presence of trace

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

Class II — Potential Health HazardOngoing
Refund
December 4, 2018· Mylan Laboratories Limited, (Nashik FDF)

Recalled Item: Valsartan Tablets

The Issue: GCMP Deviations: FDA analysis confirmed presence of trace

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

Class II — Potential Health HazardOngoing
Refund
December 4, 2018· Mylan Laboratories Limited, (Nashik FDF)

Recalled Item: Amlodipine and Valsartan Tablets

The Issue: GCMP Deviations: FDA analysis confirmed presence of trace

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

Class II — Potential Health HazardOngoing
Refund