US Drug Recall Register

FDA Drug Recalls

2,661 recalls, newest first

Class II · Moderate risk Ongoing

Estradiol Cypionate 10mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1201-2022
Class II · Moderate risk Ongoing

Dexpanthenol 250mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1199-2022
Class II · Moderate risk Ongoing

Calcium Chloride Preservative Free

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1198-2022
Class II · Moderate risk Ongoing

Biotin 5mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1197-2022
Class II · Moderate risk Ongoing

BCAAs

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1196-2022
Class II · Moderate risk Ongoing

Ascorbic Acid 500mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1195-2022
Class II · Moderate risk Ongoing

Alpha Lipoic Acid 25mg/mL

Reason Lack of Assurance of Sterility

TMC Acquisition LLC dba Tailor Made Compounding D-1192-2022
Class II · Moderate risk Ongoing

All Over-The-Counter

Reason CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center.

Dollar Tree Distribution, Inc. D-0641-2022
Class II · Moderate risk Ongoing

Luxury 70% Isopropyl Alcohol

Reason Labeling - product contains undeclared ethyl alcohol

Tsm Brands LLC D-0636-2022
Class II · Moderate risk Ongoing

Methylphenidate Hydrochloride Chewable Tablets

Reason Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.

Rising Pharmaceuticals NDC 64980-221-01 D-0573-2022
Class II · Moderate risk Ongoing

Premium Nature Instant Hand Sanitizer

Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

AMS Packaging Inc D-0647-2022
Class II · Moderate risk Ongoing

Premium Nature Instant Hand Sanitizer

Reason Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for ethanol.

AMS Packaging Inc D-0646-2022
Class II · Moderate risk Ongoing

Lexette

Reason CGMP Deviation: Difficulty dispensing/does not dispense or dispensing liquid instead of foam.

Mayne Pharma Inc NDC 51862-604-50 D-0387-2022
Class II · Moderate risk Ongoing

Medroxyprogesterone Acetate Injection

Reason Lack of Assurance of Sterility

Ideal Specialty Apothecary, Inc. dba Ideal Pharmacy D-0463-2022
Class II · Moderate risk Ongoing

Lidocaine Hydrochloride

Reason Superpotent Drug: Minimally superpotent

Teligent Pharma, Inc. NDC 63739-997-64 D-0296-2022
Class I · High risk Ongoing

Lidocaine Hydrochloride

Reason Superpotent Drug

Teligent Pharma, Inc. NDC 63739-997-64 D-0295-2022
Class II · Moderate risk Ongoing

Diclofenac Sodium Topical Solution

Reason Defective container: Out of specification for container integrity leading to bottles leaking.

Preferred Pharmaceuticals, Inc. NDC 68788-7707-01 D-0278-2022