FDA Drug Recalls

1,122 recalls, newest first

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Dual Action with Acetaminophen Acetaminophen 250 mg and Ibuprofen (NSAID) 125 mg Tablets Pain Reliever, 36 Caplets bottles

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0565-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) 24-count Caplets

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0564-2023

Class II · Moderate risk Ongoing Mar 31, 2023

Advil Ibuprofen Tablets, 200 mg Pain Reliever/Fever Reducer (NSAID) packaged in a) 100-count bottles, b) 50-count bottles, and c)…

Reason CGMP deviation: product outside labeled storage temperature requirements.

Family Dollar Stores, Llc. D-0563-2023

Class III · Low risk Terminated Mar 29, 2023

Norepinephrine Bitartrate Injection, USP, 4 mg/4 mL* (1 mg/mL), 4 mL Single-dose Fliptop Vial (NDC 47335-615-40); packaged in 10…

Reason Failed Impurities/Degradation Specifications: Above the specification limits yielded for related substance norepinephrine sulfonic acid impurity…

Sun Pharmaceutical Industries INC NDC 47335-615-40 D-0529-2023

Class III · Low risk Terminated Mar 29, 2023

Dodex Injectable Cyanocobalamin Injection, USP 1,000 mcg/mL, 25 x1 ML Multiple dose vials, For Intramuscular or Subcutaneous Use…

Reason Sub-potent drug: assay test result below specifications at 9-month timepoint.

Accord Healthcare, Inc. NDC 16729-533-08 D-0528-2023

Class I · High risk Terminated Mar 27, 2023

SOFT HANDS Alcohol Antiseptic 80%, Topical Solution, HAND SANITIZER, NON-STERILE SOLUTION, cleanpro SUPPLY, 1 US gallon /…

Reason Chemical Contamination: FDA testing found Presence of methanol

Jarman's Midwest Cleaning Systems, Inc. D-0874-2023

Class I · High risk Terminated Mar 27, 2023

Alcohol Antiseptic 80%, Topical Solution, Hand Sanitizer, Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle, MCS…

Reason Chemical Contamination: FDA testing found Presence of methanol

Jarman's Midwest Cleaning Systems, Inc. D-0873-2023

Class II · Moderate risk Terminated Mar 27, 2023

Isopropyl Alcohol Antiseptic 75%, Topical Solution, Hand Sanitizer Non-sterile Solution, Volume: 3.785 L, plastic gallon bottle…

Reason CGMP deficiencies: Product manufactured at the same site where FDA testing found Presence of methanol in other products.

Jarman's Midwest Cleaning Systems, Inc. D-0872-2023

Class III · Low risk Terminated Mar 27, 2023

Bevacizumab 2.5 mg/0.1 mL, Solution for Injection in 1mL, silicone free slip tip syringe, each Syringe supplied in individually…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: Lot code on primary packaging is incorrect.

Pine Pharmaceuticals, LLC NDC 69194-0458-1 D-0531-2023

Class III · Low risk Terminated Mar 27, 2023

Montelukast Sodium Oral Granules USP, 4 mg, packaged in a carton containing 30 packets, Rx only, Distributed By: Teva…

Reason Failed Impurities/Degradation Specifications: failed impurities for Sulphoxide and Impurity A.

Teva Pharmaceuticals USA Inc NDC 0093-7487-56 D-0510-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 1mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7596-3), b) 60-count bottle (NDC68788-7596-6); Rx…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7596-3 D-0506-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 0.5mg, (CIV), packaged in: a) 30-count bottle (NDC 68788-7595-3), b) 60-count bottle (NDC 68788-7595-6), c)…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7595-3 D-0505-2023

Class II · Moderate risk Terminated Mar 27, 2023

Alprazolam Tab, USP 0.25mg, (CIV), 30-count bottle, Rx Only, Preferred Pharmaceuticals, Inc. Manufactured by: Breckenridge…

Reason CGMP Deviations: Downstream recall from Breckenridge Pharmaceuticals, Inc due to potential risk of Cross Contamination.

Preferred Pharmaceuticals, Inc. NDC 68788-7594-3 D-0504-2023