FDA Drug Safety
U.S. Food and Drug Administration — Drug recalls and safety communications
17,379 recalls · Page 27 of 348
Critical Feb 14, 2024
Lubricant Gel Drops (Carboxymethylcellulose sodium 1.0%), packaged in 0.5 FL OZ (15 mL) bottles, Distributed by: Rite Aid 30 Hunter Lane, Camp Hill, …
Kilitch Healthcare India Limited
Low Feb 14, 2024
HydrALAZINE Hydrochloride Tablets, USP, 10 mg, 100-count (10 x 10) per unit dose carton, Rx Only, Distributed by: American Health Packaging, Columbus…
Amerisource Health Services LLC
Critical Feb 14, 2024
Leader brand Dry Eye Relief (Polyethylene glycol 400 0.4% and Propylene glycol 0.3%) packaged in 0.33 FL OZ (10 mL) bottles, Distributed by Cardinal …
Kilitch Healthcare India Limited
Critical Feb 14, 2024
Lubricant Eye Drops (Propylene glycol 0.6%), packaged in 0.33 FL OZ (10 mL) each bottle (Twin Pack), Distributed by: Rite Aid 30 Hunter Lane, Camp Hi…
Kilitch Healthcare India Limited
Moderate Feb 7, 2024
Budesonide Extended-Release Tablets, 9 mg, 30-count bottles, Rx only, Marketed by: GSMS, Incorporated, Camarillo, CA, UPC 5140782430, NDC 51407-824-30
Golden State Medical Supply Inc.
Moderate Feb 7, 2024
Budesonide Extended-Release Tablets 9mg, 30-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314 USA, Di…
Teva Pharmaceuticals USA, Inc
Critical Feb 7, 2024
VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3206, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC…
Denver Solutions, LLC DBA Leiters Health
Critical Feb 7, 2024
FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3355, for IV use only; Leiters 13796 Compark Blvd Englewood, CO …
Denver Solutions, LLC DBA Leiters Health
Critical Feb 7, 2024
Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle, Rx only, Mfd. for: Arbor Pharmaceuticals, LLC., Atlanta, Georgia, 30328…
Azurity Pharmaceuticals, Inc.
Critical Feb 7, 2024
VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F3208, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112; NDC …
Denver Solutions, LLC DBA Leiters Health
Critical Feb 7, 2024
FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL), Item F3342, for IV use only; Leiters 13796 Compark Blvd Englewood, CO …
Denver Solutions, LLC DBA Leiters Health
Critical Feb 7, 2024
PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item F3360, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112;…
Denver Solutions, LLC DBA Leiters Health
Moderate Feb 7, 2024
Hydrogen Peroxide Oral Rinse, Significantly Reduces Bacteria, Fresh Mint Flavor, Alcohol Free, a)16 fl. oz. (473 mL) bottle, NDC 59883-202-16, UPC 3 …
Den-Mat Holdings, LLC
Moderate Feb 7, 2024
Rifampin Capsules USP 150mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manuf…
Lupin Pharmaceuticals Inc.
Critical Feb 7, 2024
PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Item F3352, for IV use only; Leiters 13796 Compark Blvd Englewood, CO 80112…
Denver Solutions, LLC DBA Leiters Health
Moderate Feb 7, 2024
Rifampin Capsules USP, 150 mg, 30 Capsules (3 x 10) unit doses per carton, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. …
Amerisource Health Services LLC
Moderate Feb 7, 2024
Cefixime for Oral Suspension 100mg/5mL, 50 mL bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, Manufactured…
Lupin Pharmaceuticals Inc.
Moderate Feb 7, 2024
Rifampin Capsules USP 300mg, 30-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, Maryland 21202 United States, Manufa…
Lupin Pharmaceuticals Inc.
Moderate Feb 7, 2024
OralProCare medicated lip treatment, Net Wt 9.9 g (0.35 oz) tube, Ethyl alcohol 6.0% Antibacterial, Manufactured by: Den-Mat Holdings, LLC, Lompoc, C…
Den-Mat Holdings, LLC
Moderate Jan 31, 2024
Lurasidone Hydrochloride Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manu…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Zolpidem Tartrate Extended-Release Tablets, USP 12.5mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbur…
SUN PHARMACEUTICAL INDUSTRIES INC
Critical Jan 31, 2024
Bleomycin for Injection, USP, 15 units per vial, 1 single dose glass fliptop vial, Rx Only, Distributed by: Hospira, Inc., Lake Forest, IL 68045, NDC…
PFIZER
Moderate Jan 31, 2024
Mesalamine Delayed-Release Tablets, USP 1.2 g per tablet, Rx Only, 120 Tablets per bottle, Once Daily, Distributed by: Sun Pharmaceutical Industries,…
SUN PHARMACEUTICAL INDUSTRIES INC
Critical Jan 31, 2024
Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramine HCl 25mg), 8 FL OZ (237 mL) bottle, Distributed by: GSK Consumer Healt…
Haleon US Holdings LLC
Moderate Jan 31, 2024
Cinacalcet Tablets 60mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Su…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Lurasidone Hydrochloride Tablets 120mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Man…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Niacin Extended-Release Tablets, USP 500mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, …
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Niacin Extended-Release Tablets, USP 1000mg, Rx Only, 90 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512,…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Febuxostat Tablets 80 mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: S…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Methoxsalen Capsules, USP 10mg, 50-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd. Bengaluru - 562106, India. Distributed by:Stri…
Strides Pharma Inc.
Critical Jan 31, 2024
Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorphan HBr 20 mg), a) 4 FL OZ (118mL) and b) 8 FL OZ (237 mL) bottles, Distr…
Haleon US Holdings LLC
Moderate Jan 31, 2024
Febuxostat Tablets 40mg, Rx Only, 30 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, Manufactured by: Su…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Zolpidem Tartrate Extended-Release Tablets, USP 6.25 mg, Rx Only, 100 Tablets per bottle, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbu…
SUN PHARMACEUTICAL INDUSTRIES INC
Low Jan 31, 2024
Benzonatate Capsules, USP, 100 mg, 100 Capsules (10 capsules x 10 unit dose cards), Rx only, Distributed by: American Health Packaging, Columbus, Ohi…
Amerisource Health Services LLC
Moderate Jan 31, 2024
Fexofenadine Hydrochloride Tablets, USP 180mg, Antihistamine, Allergy, 24 hour, a) 30 Tablets per bottle, NDC 51660-998-30; Distributed by: Ohm Labor…
SUN PHARMACEUTICAL INDUSTRIES INC
Moderate Jan 31, 2024
Vasopressin 2 Unit/2 mL in 0.9% Sodium Chloride, 2 mL per syringe, Rx Only, 719 Kasota Ave SE, Minneapolis, MN. NDC 71139-0190-1
IntegraDose Compounding Services LLC
Moderate Jan 31, 2024
Fosaprepitant for Injection 150 mg per vial, Sterile lyophilized powder for Intravenous use only after reconstitution and dilution, Single Dose Vial,…
BE PHARMACEUTICALS AG
Moderate Jan 31, 2024
Fluocinolone Acetonide Oil, 0.01% (Ear Drops), package in 1 Oz. (20 mL fill volume) bottle, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd., …
Glenmark Pharmaceuticals Inc., USA
Moderate Jan 24, 2024
Freskaro refresh & revitalize Magnesium Citrate Saline Laxative Oral Solution Grape Flavor 10 fl. oz, Manufactured by: Pharma Lobis, 7400 Alumax Dr.,…
Pharma Nobis LLC
Moderate Jan 24, 2024
Good Neighbor Pharmacy, DYE FREE, SUGAR FREE Magnesium Citrate Saline Laxative, Oral Solution, Cherry Flavor 10 fl. oz, Distributed by AmerisourceBer…
Pharma Nobis LLC
Moderate Jan 24, 2024
Secret OUTLAST Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Protecting Powder, Topical spray can 3.8 oz (107 g), Dist. by: Procter & Ga…
The Procter & Gamble Company
Critical Jan 24, 2024
4.2% Sodium Bicarbonate Injection, USP 5 mEq/10 mL (0.5 mEq/mL), Glass ABBOJECT Unit of Use Syringe, For Intravenous Use, Rx Only, 10 mL Syringe per …
Pfizer Inc.
Moderate Jan 24, 2024
Old Spice Pure Sport 2021 Gift Set, Contains: Old Spice Pure Sport Body Wash 18 Fl Oz (532 mL), 2-in-1 Shampoo & Conditioner 13.5 Fl Oz (400 mL), an…
The Procter & Gamble Company
Critical Jan 24, 2024
Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 37000…
The Procter & Gamble Company
Moderate Jan 24, 2024
Secret, OUTLAST, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Completely Clean, Topical spray can 3.8 oz (107 g), Dist. by: Procter & G…
The Procter & Gamble Company
Moderate Jan 24, 2024
Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Anti-Perspirant, Topical spray can 3.8 OZ (107 g), Distr. by: Procter & Gam…
The Procter & Gamble Company
Moderate Jan 24, 2024
Old Spice, SWEAT DEFENSE PURE SPORT PLUS, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant, Topical spray can, Net WT 3.8 oz (107 g) cans, Distr. by:…
The Procter & Gamble Company
Moderate Jan 24, 2024
Secret, powder fresh, (Aluminum chlorohydrate 24%), Anti-Perspirant/Deodorant, Topical spray can Net Wt., (a) 4OZ (113g), NDC 37000-134-11, UPC 0 370…
The Procter & Gamble Company
Critical Jan 24, 2024
Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, Topical spray can Net Wt 3.8 oz (107 g), Dist. by: Procter & Gamble, Cinci…
The Procter & Gamble Company
Moderate Jan 24, 2024
Vasostrict (vasopressin in 5% Dextrose) Injection, 20 units per 100 mL (0.2 units per mL), 100 mL x 10 Single Dose Vials per carton, Ready to Use, Fo…
Par Sterile Products LLC