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FDA Drug Recalls

17,898 recalls, newest first

Class I · High risk Ongoing Feb 14, 2023

Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-Sterile Solution, 4fl. oz. [118mL], Distributed by…

Reason Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and acetal above the limits.

Nanomaterials Discovery Corporation NDC 75288-100-04 D-0455-2023

Class I · High risk Terminated Feb 13, 2023

PrimeZEN Black 6000 capsule, 2000mg, Male Sexual Performance Enhancement, 1-count blister card, Distributed by: Prime Premier…

Reason Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclared sildenafil and tadalafil, ingredients found in…

Volt Candy Wholesale Club D-0453-2023

Class II · Moderate risk Completed Feb 10, 2023

0.9% Sodium Chloride Injection, USP, 500 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC…

Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…

B. Braun Medical Inc. NDC 0264-5802-10 D-0347-2023

Class II · Moderate risk Completed Feb 10, 2023

0.9% Sodium Chloride Injection, USP, 1000 mL Excel Plus Container, Rx Only, B. Braun Medical Inc. Bethlehem, PA 18018, NDC…

Reason Lack of sterility assurance: Recall of certain batches of 0.9% Sodium Chloride for Injection USP in EXCEL¿ Plus IV Container product due to the…

B. Braun Medical Inc. NDC 0264-5802-00 D-0346-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 36800-691-39), b)45-count…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 36800-691-39 D-0912-2023

Class II · Moderate risk Terminated Feb 9, 2023

Picnic, Fexofenadine Hydrochloride Tablets, 180 mg, Antihistamine, 90-count cartons, Distributed by: Thirty Madison, Inc., New…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company D-0911-2023

Class II · Moderate risk Terminated Feb 9, 2023

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 11673-617-22), b)30-count cartons…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 11673-617-22 D-0910-2023

Class II · Moderate risk Terminated Feb 9, 2023

allergyrelief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)30-count cartons (NDC 56062-847-39); and b) 45-count…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 56062-847-39 D-0909-2023

Class II · Moderate risk Terminated Feb 9, 2023

Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 0113-0847-39), and b) 45-count cartons (NDC…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 0113-0847-39 D-0908-2023

Class II · Moderate risk Terminated Feb 9, 2023

Fexofenadine Hydrochloride Tablets, 180 mg, 100-count cartons, Distributed by: Perrigo, Allegan, MI 49010. NDC 45802-847-78

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 45802-847-78 D-0907-2023

Class II · Moderate risk Terminated Feb 9, 2023

allergy relief, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a)15-count cartons (NDC 79481-0847-0), b)30-count cartons…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 79481-0847-0 D-0906-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy ALLER-FEX, Fexofenadine Hydrochloride Tablets, 180 mg, 180-count cartons, Packaged by: Perrigo, 515 Eastern Ave…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 63981-847-48 D-0905-2023

Class II · Moderate risk Terminated Feb 9, 2023

aller-ease, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Packaged For: Your Military Exchanges, By: Perrigo…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 55301-847-39 D-0904-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 30-count cartons, Distributed By: CVS Pharmacy, Inc., One CVS Drive…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 69842-0914-39 D-0903-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 15-count cartons, Distributed By: Adusa Distribution, LLC, Salisbury…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 72476-847-22 D-0902-2023

Class II · Moderate risk Terminated Feb 9, 2023

Non-Drowsy Allergy Relief, Fexofenadine Hydrochloride Tablets, 180 mg, 150-count cartons, Distributed By: BJ's Wholesale Club, 25…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 68391-847-47 D-0901-2023

Class II · Moderate risk Terminated Feb 9, 2023

Allergy, Fexofenadine Hydrochloride Tablets, 180 mg, packaged in a) 30-count cartons (NDC 72288-847-39), and b)150-count cartons…

Reason Failed Impurities/Degradation Specifications

L. Perrigo Company NDC 72288-847-39 D-0900-2023

Class II · Moderate risk Terminated Feb 9, 2023

Maximum Zone2 Topical Analgesic, 1oz bottle, for use during a pain sensitive procedure, distributed by: DERMAL SOURCE, Portland…

Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

HTO Nevada, Inc. D-0271-2023

Class II · Moderate risk Terminated Feb 9, 2023

New & Improved Blue Gel Anesthetic, to reduce pain and swelling during pain sensitive procedures, 1 oz bottle, distributed by…

Reason cGMP Deviation: Raw material recalled by repackager, due to discoloration of the epinephrine API.

HTO Nevada, Inc. D-0270-2023

Class II · Moderate risk Ongoing Feb 8, 2023

Fentanyl 500mcg (2mcg/mL) and Ropivacaine HCl 250mg (1mg/mL) added to 250mL 0.9% Sodium Chloride, For Epidural Use Only, Rx only…

Reason Lack of assurance of sterility: Suspected microbial growth present on external label packaging.

Apollo Care NDC 71170-950-25 D-0487-2023

Class II · Moderate risk Ongoing Feb 8, 2023

Tacrolimus Capsules, USP, 0.5 mg, 100-count bottle, Rx Only, Mfd. by Dr. Reddy's Laboratories Limited, Bachupally - 500 090…

Reason Presence of Foreign Tablets/Capsules: Presence of one Tacrolimus 1 mg capsule co-mingled in a bottle containing and labeled as Tacrolimus 0.5 mg…

Dr. Reddy's Laboratories, Inc. NDC 55111-525-01 D-0330-2023

Class II · Moderate risk Terminated Feb 7, 2023

rOPINIRole Tablets USP 5 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-238-01 D-0431-2023

Class II · Moderate risk Terminated Feb 7, 2023

rOPINIRole Tablets USP 4 mg* 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-237-01 D-0430-2023

Class II · Moderate risk Terminated Feb 7, 2023

rOPINIRole Tablets USP 3 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manufactured…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-236-01 D-0429-2023

Class II · Moderate risk Terminated Feb 7, 2023

rOPINIRole Tablets USP 2 mg*, 100-count bottle, Rx Only, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Reason CGMP Deviations: recalling drug products following an FDA inspection.

Accord Healthcare, Inc. NDC 16729-235-01 D-0428-2023