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Search our full database of product recalls from FDA, CPSC, NHTSA, and USDA. Find recalls by product name, brand, manufacturer, hazard type, or keyword.

PlainRecalls indexes tens of thousands of recall records across multiple federal agencies. Use the search box below to find specific products or browse by agency, category, or date on the respective listing pages. Search results include the recall title, the recalling firm, severity classification, and the date the recall was announced.

Found 298 recalls matching "phenylephrine"

FDA Drug Moderate Aug 9, 2023

PHENYLephrine, 10mg/250ml added to 0.9% sodium chloride, 40mcg/mL, IV Bag, Rx Only, Central Admixture Pharmacy Services, Inc., 2200 South 43rd Avenue…

Central Admixture Pharmacy Services, Inc.

FDA Drug Moderate Aug 9, 2023

PHENYLephrine 1,000 mcg/10mL, (100mcg/mL) in 0.9% sodium chloride, Syringe, Rx Only, CAPS, Inc., 2200 South 43rd Avenue, Phoenix, AZ 85043, NDC: 7219…

Central Admixture Pharmacy Services, Inc.

FDA Drug Moderate Jul 26, 2023

PHENYLephrine HCl 10mg added to 0.9% Sodium Chloride 250mL, 250 mL IV Bag @60 Total volume), RX only, Advanced Compounding Solutions, 4 Constitution …

New England Life Care, Inc. dba Advanced Compounding Solutions

FDA Drug Critical Jun 7, 2023

G-Supress DX (Dextromethorphan HBr, Guaifenesin, Phenylephrine HCl) Pediatric Drops Cough Suppressant Expectorant Nasal Decongestant, Cherry Flavor S…

Novis PR, LLC dba Kramer Novis

FDA Drug Low Jun 7, 2023

Phenylephrine HCl 20 mg added to 0.9% Sodium Chloride 250mL Bag, Rx Only, Compounded by: Advanced Compounding Solutions, 4 Constitution Way Ste L Wob…

New England Life Care, Inc. dba Advanced Compounding Solutions

FDA Drug Moderate May 31, 2023

PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Sno…

Central Admixture Pharmacy Services, Inc.

FDA Drug Moderate May 31, 2023

phenylephrine 50 mg added to 0.9% sodium chloride 250 mL*, 200 mcg/mL*, 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snow…

Central Admixture Pharmacy Services, Inc.

FDA Drug Moderate May 31, 2023

PHENYLephrine added to 0.9% sodium chloride, 10 mg/250 mL* (40 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snow…

Central Admixture Pharmacy Services, Inc.

FDA Drug Moderate May 31, 2023

PHENYLephrine added to 0.9% sodium chloride, 25 mg/250 mL* (100 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Sno…

Central Admixture Pharmacy Services, Inc.

FDA Drug Moderate May 31, 2023

PHENYLephrine added to 0.9% sodium chloride, 20 mg/250 mL* (80 mcg/mL), 250 mL per bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snow…

Central Admixture Pharmacy Services, Inc.

FDA Drug Moderate May 24, 2023

PHENYLephrine HCl Injection, 1 mg per 10 mL (100 mcg/mL), Single-Use Syringe, Solution for IV Use Only. Apollo Care, LLC, 3801 Mojae Ct., Suite 101,…

Apollo Care, LLC

FDA Drug Moderate Mar 15, 2023

Phenylephrine HCl 40 mg (160 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Leiter Compounding Health 13796 Compark Blvd Englewood CO 80112, N…

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Mar 15, 2023

Phenylephrine HCl 0.5 mg per 5 mL (100 mcg/mL), 5 mL Syringe, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-11

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Mar 15, 2023

Phenylephrine HCl 1mg per 10mL (100 mcg/mL) 10 mL syringes, Rx only, Leiters 13796 Compark Blvd Englewood CO 80112, NDC 71449-001-15

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Mar 15, 2023

Phenylephrine HCl 20 mg (80 mcg/mL) added to 0.9% Sodium Chloride 250 mL IV Bag, Rx only, Leiters Compounding Health 13796 Compark Blvd Englewood CO …

Denver Solutions, LLC DBA Leiters Health

FDA Drug Moderate Mar 8, 2023

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Sterile Single-Dose Vials per carton, 12 x …

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Mar 8, 2023

Phenylephrine HCl in 0.9% Sodium Chloride Injection, USP, 50 mg/250 mL (200 mcg/mL), 250 mL Single-Dose Container bottle, packaged in 15 x 1 IV Bottl…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Mar 8, 2023

Phenylephrine Hydrochloride Injection, USP 10 mg/mL Rx Only, 1 mL Single Dose Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Manuf…

Accord Healthcare, Inc.

FDA Drug Moderate Mar 8, 2023

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vial…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Mar 8, 2023

Phenylephrine Hydrochloride Injection, USP 100 mg/10 mL (10 mg/mL), Rx Only, 10 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703…

Accord Healthcare, Inc.

FDA Drug Moderate Mar 8, 2023

Phenylephrine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), Rx Only, 5 mL Vial, Manufactured for: Accord Healthcare, Inc., Durham, NC 27703 Man…

Accord Healthcare, Inc.

FDA Drug Moderate Mar 8, 2023

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Single-Dose Vial, packaged in 30 x 10 mL Single-Dose Vials per carton, 12 x 30 Vial…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Nov 9, 2022

LIDOCAINE/PHENYLEPHRINE PF SYR 1%/1.5% Solution, 3 mL syringes, Rx only, Vital Care Compounder, 115 S. 40th Ave., Hattiesburg, MS 39402

Pharmacy Plus, Inc. dba Vital Care Compounder

FDA Drug Low Oct 26, 2022

NDC 0363-6171-09 Walgreens Sinus Pressure, Pain & Cough ACETAMINOPHEN/ PAIN RELIEVER DEXTROMETHORPHAN HBr/ COUGH SUPPRESSANT GUAIFENESIN/ EXPECTORAN…

LNK International, Inc.

FDA Drug Moderate Jul 27, 2022

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per ca…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Jul 27, 2022

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL) syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per cas…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Jul 27, 2022

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL)syringe, packaged in 5 x 10 mL Pre-Filled Syringes per carton, 6 x 5 Syringe Carton per cas…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Jun 8, 2022

Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, N…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Jun 8, 2022

Phenylephrine HCl Injection, USP, 0.8 mg/10 mL (80 mcg/mL), 10 mL Pre-Filled Syringes, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, …

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Jun 8, 2022

Phenylephrine HCl Injection, USP, 1 mg/10 mL (100 mcg/mL), 10 mL Pre-Filled Syringe, 5 x 10 mL Pre-Filled Syringes, 6 x 5 Syringe Carton, Rx Only, Ne…

Nephron Sterile Compounding Center LLC

FDA Drug Moderate Jun 1, 2022

Phenylephrine 1 mg/mL, Multi-Dose 5 mL vial, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155 Orlando, FL 32835. NDC 73198-0021-05.

Olympia Compounding Pharmacy dba Olympia Pharmacy

FDA Drug Moderate May 4, 2022

Phenylephrine 1 mg/mL, 5 mL Multi-Dose vial, Rx Only, Olympia Pharmaceuticals 6700 Convoy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0021-05.

Olympia Compounding Pharmacy dba Olympia Pharmacy

FDA Drug Moderate Mar 30, 2022

Phenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-…

Athenex Pharma Solutions, LLC

FDA Drug Moderate Mar 30, 2022

Phenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, …

Athenex Pharma Solutions, LLC

FDA Drug Moderate Mar 30, 2022

Phenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, …

Athenex Pharma Solutions, LLC

FDA Drug Moderate Feb 16, 2022

Coated APAP 325 mg Phenyl HCl 5 mg tablet (Acetaminophen 325 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY ND…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

4-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Dextromethorphan HBr 15mg, Phenylephrine HCL 5mg) Bulk Container, ULTRAtab Laborator…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Kramer Novis Tusicof Caplet (Guaifenesin 400 mg, Dextromethorphan HBr 20 mg, Phenylephrine HCl 10 mg) Bulk Container, ULTRAtab Laboratories, Inc., Hi…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Coated Phenylephrine HCl 5mg Tablet (Phenylephrine HCl 5mg ) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-338-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Phenylephrine HCl 5 mg Tablet (Phenylephrine HCl 5mg) Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-333-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

Zee Cold Tabs (Acetaminophen 325 mg, Guaifenesin 100 mg, Phenylephrine HCl 5 mg Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

APAP 325 mg/Phenylephrine HCl, 5mg Tablets Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-135-00

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 16, 2022

APAP 500 mg Phenyl HCl 5mg tablet (Acetaminophen 500mg, Phenylephrine HCl 5mg), Bulk Container, ULTRAtab Laboratories, Inc., Highland, NY NDC 62959-…

ULTRAtab Laboratories, Inc.

FDA Drug Moderate Feb 9, 2022

Pain & Sinus Reliever Pain Reliever/Nasal Decongestant (acetaminophen 500mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg for Advanced First Aid, Bal…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

COLD TERMINATOR decongestant/cold relief (acetaminophen 325 mg, Guaifenesin 200mg, 5.0 Phenylephrine HCl) 2 tablet packets, Manufactured for: Tellus …

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Cold Relief (acetaminophen 250 mg, guaifenesin 200mg, phenylephrine HCl 5 mg) 2 tablets per packet, Mfd. for First Aid Direct, Mason, OH 45040, NDC 4…

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040

Ultra Seal Corporation

FDA Drug Moderate Feb 9, 2022

DILOTAB II, SINUS AND COLD RELIEF NON DROWSY (acetaminophen 325 mg, Phenylephrine HCl 5 mg) 2 tablet packets, Dist. by ZEE Medical Distributors, LLC …

Ultra Seal Corporation

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