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
2 this month

Showing 4001–4020 of 17,529 recalls

December 6, 2021· Edge Pharma, LLC

Recalled Item: Lidocaine HCL / Bupivacaine HCL (contains Hyaluronidase 15 units/mL)

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: PHENYLephrine

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: Trypan Blue 0.03%

The Issue: CGMP Deviations

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: LT Topical Cream

The Issue: CGMP Deviations

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: Lidocaine HCl/Phenylephrine HCl Nasal Solution

The Issue: CGMP Deviations

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: Vancomycin HCl in 0.9 % Sodium Chloride Injection

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: Ceftazidime

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: CSF Otic Insufflation Capsule

The Issue: CGMP Deviations

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: Methotrexate

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: Tetracaine HCl Nasal Solution

The Issue: CGMP Deviations

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Edge Pharma, LLC

Recalled Item: Phenylephrine HCl

The Issue: Sterility Concerns

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Medique Products

Recalled Item: Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen

The Issue: CGMP Deviations: manufacturer recalled after an FDA inspection

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Medique Products

Recalled Item: Extra Strength Headache (acetaminophen 250 mg

The Issue: CGMP Deviations: manufacturer recalled after an FDA inspection

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Medique Products

Recalled Item: Medique Pain-Off (Acetaminophen 250 mg

The Issue: CGMP Deviations: manufacturer recalled after an FDA inspection

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

Class II — Potential Health HazardTerminated
Refund
December 6, 2021· Valisa MFG LLC

Recalled Item: kleantouch HAND SANITIZER (ethyl alcohol 70%)

The Issue: Marketed Without an Approved NDA/ANDA: Product labeled to

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

Class I — Serious Health HazardTerminated
Refund
December 3, 2021· Dental Alliance Holdings LLC

Recalled Item: CTx7 Kit

The Issue: Subpotent Drug: Product contains less Sodium Fluoride than

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

Class III — Low RiskTerminated
Refund
December 3, 2021· Dental Alliance Holdings LLC

Recalled Item: CariFree sample boxes

The Issue: Subpotent Drug: Product contains less Sodium Fluoride than

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

Class III — Low RiskTerminated
Refund
December 3, 2021· Dental Alliance Holdings LLC

Recalled Item: CTx12 5000 Kit which contains 3 boxes of CariFree CTx4

The Issue: Subpotent Drug: Product contains less Sodium Fluoride than

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

Class III — Low RiskTerminated
Refund
December 3, 2021· Dental Alliance Holdings LLC

Recalled Item: CTx21 Kit

The Issue: Subpotent Drug: Product contains less Sodium Fluoride than

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

Class III — Low RiskTerminated
Refund
December 3, 2021· Dental Alliance Holdings LLC

Recalled Item: CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint

The Issue: Subpotent Drug: Product contains less Sodium Fluoride than

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

Class III — Low RiskTerminated
Refund