Skip to content

FDA Drug Recalls

17,898 recalls, newest first

Class III · Low risk Ongoing Mar 8, 2023

MEKTOVI (binimetinib) tablets, 15 mg, 180-count bottle, Rx only, Distributed by: Array BioPharma Inc., a wholly owned subsidiary…

Reason Labeling: Incorrect or Missing Lot and/or Exp Date: The carton and bottle labels state an expiry date of March 2026; the correct expiration date is…

Pfizer Inc. D-0532-2023

Class II · Moderate risk Terminated Mar 2, 2023

Calcitonin Salmon Nasal Spray, USP, 2200 International Units per mL corresponding to 200 International Units/spray, 3.7 mL…

Reason Failed Impurities/Degradation Specifications and Subpotent Drug: High Out of Specification results for a known and unknown impurity as well as low…

Endo Pharmaceuticals, Inc. NDC 49884-161-11 D-0475-2023

Class II · Moderate risk Terminated Mar 2, 2023

Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA…

Reason CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc NDC 51991-901-01 D-0463-2023

Class II · Moderate risk Terminated Mar 2, 2023

Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Centaur Pharmaceuticals Pvt. Ltd., Pune, INDIA…

Reason CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc NDC 51991-900-01 D-0462-2023

Class II · Moderate risk Terminated Mar 2, 2023

Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 51991-0707-01) and b) 500-count bottle (NDC…

Reason CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc NDC 51991-0707-01 D-0461-2023

Class II · Moderate risk Terminated Mar 2, 2023

Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0706-01), b) 500-count bottle (NDC 51991-0706-05)…

Reason CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc NDC 51991-0706-01 D-0460-2023

Class II · Moderate risk Terminated Mar 2, 2023

Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0705-01), b) 500-count bottle (NDC…

Reason CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc NDC 51991-0705-01 D-0459-2023

Class II · Moderate risk Terminated Mar 2, 2023

Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 51991-0704-01), b) 500-count bottle and c)…

Reason CGMP Deviations: Potential risk of Cross Contamination

Breckenridge Pharmaceutical, Inc NDC 51991-0704-01 D-0458-2023

Class II · Moderate risk Terminated Mar 1, 2023

Heparin Sodium, 25,000USP units per 250 mL, (100 USP units per mL) in 5% Dextrose Injection, 250 mL Excel Container, B.Braun…

Reason Subpotent Drug: low Anti-Factor IIa potency.

B. Braun Medical Inc NDC 0264-9587-20 D-0434-2023

Class II · Moderate risk Completed Mar 1, 2023

Brimonidine Tartrate Ophthalmic Solution 0.15%, Rx Only, Packaged as: a) 5 mL dropper bottle, NDC 60505-0564-1, UPC 3 60505 05641…

Reason Lack of sterility assurance: Cracks have developed in some of the units caps of Brimonidine tartrate ophthalmic solution bottles. There is a…

Apotex Corp. NDC 60505-0564-1 D-0433-2023

Class II · Moderate risk Terminated Feb 28, 2023

Heparin Sodium Injection, USP, 20,000 USP units per mL, 25 x 1 mL Multi-Dose Vials, Rx Only, For Intravenous or Subcutaneous Use…

Reason Labeling: Not elsewhere classified

Sagent Pharmaceuticals Inc D-0435-2023

Class I · High risk Ongoing Feb 24, 2023

Delsam Pharma's Artificial Eye Ointment (Mineral Oil 15%, White Petrolatum 83%), 3.5 grams (1/8 oz.) tube, Distributed By: Delsam…

Reason Non-Sterility: FDA analysis found unopened tubes to be contaminated with bacteria.

Global Pharma Healthcare Private Limited D-0488-2023

Class III · Low risk Terminated Feb 24, 2023

Colchicine Tablets, USP 0.6 mg, Rx Only, a) 30 tablets per bottle, NDC 16714-0039-01, b) 100 tablets per bottle, NDC…

Reason Failed Impurities/Degradation Specifications: An out-of-specification (OOS) result was observed during release testing of one lot for a related…

Zydus Pharmaceuticals (USA) Inc NDC 16714-0039-01 D-0467-2023

Class II · Moderate risk Terminated Feb 24, 2023

Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide…

Reason CGMP DEVIATIONS

Ecometics, Inc. D-0452-2023

Class II · Moderate risk Terminated Feb 24, 2023

Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid oral rinse plastic bottles, Manufactured for: All USA…

Reason CGMP DEVIATIONS

Ecometics, Inc. D-0451-2023

Class II · Moderate risk Terminated Feb 24, 2023

Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in 0.46 oz. (13g) metal tubes, Distributed by…

Reason CGMP DEVIATIONS

Ecometics, Inc. D-0450-2023

Class II · Moderate risk Terminated Feb 24, 2023

Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) plastic jars and b) 3 Oz (85g) plastic jars

Reason CGMP DEVIATIONS

Ecometics, Inc. D-0449-2023

Class II · Moderate risk Terminated Feb 24, 2023

Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Oxide 6.6%) packaged in 1 oz. (28g) metal…

Reason CGMP DEVIATIONS

Ecometics, Inc. D-0448-2023

Class II · Moderate risk Terminated Feb 24, 2023

Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed by: The Larkspur Group Inc. Norwalk, CT 06854

Reason CGMP DEVIATIONS

Ecometics, Inc. D-0447-2023

Class II · Moderate risk Terminated Feb 24, 2023

Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (207 ml) and b) 16 fluid oz. (472 ml) bottles…

Reason CGMP DEVIATIONS

Ecometics, Inc. D-0446-2023

Class III · Low risk Terminated Feb 24, 2023

Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentration = 50 mcg/mL, Preservative Free, Rx Only, Single…

Reason Subpotent Drug

SCA Pharmaceuticals NDC 70004-0200-16 D-0363-2023

Class II · Moderate risk Terminated Feb 23, 2023

Clear Eyes, Once Daily, Eye Allergy Itch Relief, olopatadine hydrochloride ophthalmic solution, USP, 0.2%, Antihistamine, 2.5 mL…

Reason Failed Impurities Specification: Out-of-specification (OOS) stability test result was obtained for unspecified impurity.

Teva Pharmaceuticals USA Inc NDC 67172-504-01 D-0469-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NaturalCare, children's, Allergy Care, Homeopathic, 4 Months and Up, Liquid Drops, 0.1% Alcohol, 1 FL OZ( 30mL), Mfd…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0440-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NaturalCare bioAllers, Mold, Yeast and Dust, Homeopathic, Liquid Drops, 20% Alcohol, 1 FL OZ( 30mL), Mfd. for Nutraceutical Corp…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0439-2023

Class II · Moderate risk Ongoing Feb 23, 2023

NatraBio, Cold& Sinus Nasal Spray, Homeopathic Medicine, 0.8 FL Oz. ( 24ml), Mfd. for Healthway Corp. Comments or Questions…

Reason CGMP Deviations: Raw material recalled by repackager, due to discoloration.

Nutraceutical Corporation D-0438-2023