US Drug Recall Register

FDA Drug Recalls

11,815 recalls · Class II, newest first

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 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 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 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
Class II · Moderate risk Terminated

Methylcobalamin 10 mg/mL Injection

Reason Lack of Assurance of Sterility.

First Pharma Associates LLC dba Riverpoint Pharmacy D-1478-2019
Class II · Moderate risk Terminated

Methylcobalamin 1 mg/mL Injection

Reason Lack of Assurance of Sterility.

First Pharma Associates LLC dba Riverpoint Pharmacy D-1477-2019
Class II · Moderate risk Terminated

Hydroxocobalamin 10 mg/mL Injection

Reason Lack of Assurance of Sterility.

First Pharma Associates LLC dba Riverpoint Pharmacy D-1476-2019
Class II · Moderate risk Terminated

Diphenhydramine HCL Liquid

Reason Microbial Contamination of Non-sterile Products: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).

H J Harkins Company Inc dba Pharma Pac NDC 52959-0123-03 D-1430-2019