US Drug Recall Register

FDA Drug Recalls

14,801 recalls, newest first

Class II · Moderate risk Terminated

Hydrocortisone Cream

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0638-03 D-1733-2019
Class II · Moderate risk Terminated

Hydrocortisone Cream With Aloe

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0620-04 D-1732-2019
Class II · Moderate risk Terminated

Hydrocortisone Cream With Aloe

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0620-03 D-1731-2019
Class II · Moderate risk Terminated

Adult Glycerin Suppositories

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0441-00 D-1730-2019
Class II · Moderate risk Terminated

Adult Glycerin Suppositories

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0441-50 D-1729-2019
Class II · Moderate risk Terminated

Adult Glycerin Suppositories

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0445-25 D-1728-2019
Class II · Moderate risk Terminated

Children Glycerin Suppositories Laxative for ages 2 to 5. Package…

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0440-25 D-1727-2019
Class II · Moderate risk Terminated

CVS Therapeutic Menthol Gel

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. D-1726-2019
Class II · Moderate risk Terminated

Eczema Lotion Hydrocortisone 1% / Anti-Itch Lotion

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. NDC 0363-0670-04 D-1725-2019
Class II · Moderate risk Terminated

CVS Health Glycerin Suppositories

Reason CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.

US Pharmaceuticals Inc. D-1724-2019
Class II · Moderate risk Terminated

Hydrocodone Polistirex and Chlorpheniramine Polistirex…

Reason Superpotent Drug and Failed Stability Specifications: High out-of-specification results for the active ingredients, hydrocodone and chlorpheniramine, as well as high out-of-specification results for the preservatives.

Tris Pharma Inc. NDC 27808-086-02 D-1517-2019
Class III · Low risk Terminated

Gatifloxacin Ophthalmic Solution 0.5%

Reason Labeling: Missing label; Product complaints reported missing bottle label.

Lupin Pharmaceuticals Inc. NDC 68180-435-01 D-1490-2019
Class II · Moderate risk Terminated

Equate Night-time Sleep Aide

Reason Microbial contamination of non-sterile product

LNK International, Inc. NDC 49035-330-02 D-1630-2019
Class I · High risk Terminated

Drospirenone and Ethinyl Estradiol Tablets

Reason Failed dissolution specifications : failed results at the 3-month stability time point.

Jubilant Cadista Pharmaceuticals, Inc. NDC 59746-763-43 D-1837-2019
Class II · Moderate risk Terminated

Milrinone Lactate Injection 200 mcg

Reason Lack of Assurance of Sterility: Bags have the potential to leak.

Pfizer Inc. NDC 0409-2776-23 D-1487-2019
Class II · Moderate risk Terminated

Milrinone Lactate Injection 200 mcg

Reason Lack of Assurance of Sterility: Bags have the potential to leak.

Pfizer Inc. NDC 0409-2776-02 D-1486-2019
Class II · Moderate risk Terminated

Gablofen

Reason Failed Impurities/Degradation Specification -This recall is being initiated as a precaution due to the presence of an unknown impurity observed during shelf life of the product.

Piramal Critical Care, Inc. NDC 66794-151-01 D-1742-2019
Class II · Moderate risk Terminated

Kaitlib Fe norethindrone and ethinyl estradiol chewable tablets

Reason Failed Impurities/Degradation Specifications: Kaitlib Fe Tablets has an out of specification result observed in long term stability study.

Lupin Pharmaceuticals Inc. NDC 68180-903-11 D-1565-2019
Class I · High risk Terminated

Fluorouracil Injection

Reason Presence of Particulate Matter; glass particulates

Fresenius Kabi USA, LLC NDC 63323-117-69 D-1489-2019
Class II · Moderate risk Terminated

Serum Tears 20% Eye Drops PF Solution

Reason Lack of Assurance of Sterility.

First Pharma Associates LLC dba Riverpoint Pharmacy D-1485-2019
Class II · Moderate risk Terminated

Chorionic Gonadotropin 2

Reason Lack of Assurance of Sterility.

First Pharma Associates LLC dba Riverpoint Pharmacy D-1483-2019