Browse Drug Recalls
207 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 207 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.
Drug Safety Recalls
Browse 207 FDA drug recalls in CT.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 9, 2023 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride, (Concentration = 0.2mg/... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | neostigmine methylsulfate 5 mg/5 mL Injection, (Concentration = 1mg/mL), 5 mL... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 2,500 mcg/50 mL in 0.9 % Sodium Chloride Injection (Concentration = ... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 2,500 mcg/250 mL in 0.9% Sodium Chloride Injection (Concentration = ... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | SUCcinylcholine Chloride 100 mg/5mL Injection (Concentration = 20mg/mL), 5 mL... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 400 mcg/10 mL in 0.9% Sodium Chloride Injection, (Concentra... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | HYDROmorphone HCl 10 mg/50 mL in 0.9% Sodium Chloride Injection (Concentratio... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 1,250 mcg/25 mL Injection (Concentration = 50 mcg/mL), 25 mL fill in... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | fentaNYL 100 mcg/50 mL, Bupivacaine HCl 0.125% in 0.9% Sodium Chloride 50 mL ... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 40 mg in 0.9% Sodium Chloride Injection, (Concentration = 1... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | HYDROmorphone HCl 30 mg/30 mL in 0.9% Sodium Chloride Injection, (Concentrati... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | labetalol HCl 20 mg/4mL Injection, (Concentration=5 mg/mL), 4 mL fill Syringe... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Nov 9, 2023 | PHENYLephrine HCl 5000 mcg/50 mL in 0.9% Sodium Chloride Injection, (Concentr... | Lack of Assurance of Sterility | Class II | SCA Pharmaceuticals, LLC |
| Aug 9, 2023 | YAGER'S LINIMENT (Camphor and Turpentine Oil) 3.1% and 8.12% respectively, pa... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | Unguentine Ointment, (Camphor 3.0%, Phenol 2.5%, Tannic Acid 2.2%, Zinc Oxide... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | Blis-To-Sol Liquid (Tolnaftate), 1%, packaged in a) 1 FLUID OZ. (29.5 mL) bot... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | ALCOLADO RELAMPAGO (Menthol and Camphor), 1% and 1.5% respectively, packaged ... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | AstrinGyn (Ferric Subsulfate) Aqueous, 259 mg/g, 8 gm Single Use Vials, Manuf... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | Lugol's (Strong Iodine Solution USP), Each mL contains Iodine 0.05gm and pota... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Aug 9, 2023 | activator concentrate, Sodium Fluoride 0.96% in Activator Concentrate; 0.08% ... | CGMP Deviations: Products not manufactured under current good manufacturing practices. | Class II | Ecometics, Inc. |
| Jul 20, 2023 | FentaNYL 500 mcg/250 mL - Bupivacaine HCl 0.1% in 0.9% Sodium Chloride 250mL ... | cGMP deviations: due to shipment of rejected units. | Class II | SCA Pharmaceuticals |
| Apr 10, 2023 | Oxytocin 30 units added to 0.9% Sodium Chloride 500 mL, Rx Only, Single Dose ... | Subpotent Drug: Out of specification results for low potency was obtained. | Class III | SCA Pharmaceuticals |
| Mar 9, 2023 | JARDIANCE (Empagliflozin), 25 mg Tablets, packaged in a) 30-count (NDC0597-01... | Labeling: Label Mix-up | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
| Mar 2, 2023 | Clobazam Tablets, 20 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Clobazam Tablets, 10 mg, CIV, 100-count bottle, Rx only, Manufactured by Cent... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 2 mg, CIV, packaged in: a)100-count bottle (NDC 5199... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.5mg, CIV, packaged in: a) 100-count bottle (NDC 51... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 0.25mg, CIV, packaged in: a) 100-count bottle (NDC 5... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Mar 2, 2023 | Alprazolam Tablets, USP, 1 mg, CIV, packaged in: a) 100-count bottle (NDC 519... | CGMP Deviations: Potential risk of Cross Contamination | Class II | Breckenridge Pharmaceutical, Inc |
| Feb 24, 2023 | Nose Better Gel (0.75% Camphor, 0.50% Menthol, 0.50% Allantoin), packaged in ... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Fentanyl 1,500 mcg/30 mL syringe, Injection for Intravenous Use, Concentratio... | Subpotent Drug | Class III | SCA Pharmaceuticals |
| Feb 24, 2023 | Soltice Quick-RUB (Menthol 5.1%, Camphor 5.1%) packaged in a) 1.33 oz (37g) p... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Unguentine Original Ointment for Burns (Camphor 3.0%, Phenol 2.5%, Tannic Aci... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Vencedor medicated balm (capsaicin 0.028%) 1.5 oz. (43g) tubes, Distributed b... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Activator Concentrate (sodium fluoride 0.96% in Activator) 1 fl. Oz, liquid o... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Alcolado Relampago (menthol 1%, camphor 1.5%), packaged in a) 7 fluid oz. (20... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Feb 24, 2023 | Unguentine Original Maximum Strength Pain Relieving/Antiseptic Ointment (Camp... | CGMP DEVIATIONS | Class II | Ecometics, Inc. |
| Jul 29, 2022 | Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.... | Chemical contamination: presence of benzene | Class I | Edgewell Personal Care Brands, LLC |
| Apr 25, 2022 | Fentanyl 2mcg/ml and Bupivacaine 0.125% in 0.9% Sodium Chloride 100 mL bags, ... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 25, 2022 | Norepinephrine 8mg in 0.9% Sodium Chloride 250 mL bag, Rx only, SCA Pharmaceu... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Apr 25, 2022 | Vancomycin HCl 1.5 g in 0.9% Sodium Chloride, 500 mL bags, Rx only, SCA Pharm... | CGMP Deviations | Class II | SCA Pharmaceuticals |
| Feb 16, 2022 | Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), p... | Chemical contamination: Presence of benzene | Class I | TCP HRB ACQUISITON LLC |
| Feb 16, 2022 | Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packag... | Chemical contamination: Presence of benzene | Class I | TCP HRB ACQUISITON LLC |
| Feb 16, 2022 | Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%)... | Chemical contamination: Presence of benzene | Class I | TCP HRB ACQUISITON LLC |
| Sep 30, 2021 | Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | cGMP Deviations | Class II | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | cGMP Deviations | Class II | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 1... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
Frequently Asked Questions
When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.
The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.
Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.