💊

Drugs Recalls

Prescription and over-the-counter medications

17,302 Total Recalls

LCL-2-0191, 5 gallon carboys, Rx only, Manufactured for: LaCore Labs, LLC, by: Washington Homeopathic Products, Inc.260 J R Hawvermale Way Berkeley Springs West Virginia 25411

Washington Homeopathic Products

Class I - Dangerous

An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Mar 18, 2021 Prescription Drugs View Details →

Mometasone Furoate Topical Solution, USP, 0.1%, (Lotion), a) 30 mL (NDC 0713-0701-85) and b) 60 mL (NDC 0713-0701-53), Rx Only, Distributed by: Cosette Pharmaceuticals, Inc., South Plainfield, NJ 07080

Cosette Pharmaceuticals

Class I - Dangerous

CGMP Deviaitons

Mar 25, 2021 Prescription Drugs Nationwide View Details →

Neomycin Sulfate Tablets, USP 500mg, Rx Only, 10x10 Unit dose 100 Tablets, Manufactured for: X-GEN Phamaceuticals, Inc. Big Flats, NY 14814. NDC 39822-0310-5

X-Gen Pharmaceuticals

Class I - Dangerous

Failed Stability Specifications: Out of Specification (OOS) result reported for microbiological assay

Mar 19, 2021 Prescription Drugs Nationwide View Details →

Telmisartan Tablets, USP 20 mg, 30-count bottles, Rx only, Manufactured by: Alembic Pharmaceuticals Limited (Formulation Division) Panelav 38935, Gujarat, India Manufactured for: Alembic Pharmaceuticals, Inc. 750 Route 202, Bridgewater, NJ 08807, NDC 62332-087-30

Alembic Pharmaceuticals Limited

Class I - Dangerous

Labeling: Label-mixup

Mar 17, 2021 Prescription Drugs Nationwide View Details →

Macula Pellets Homeopathic Medicine, 1 Oz bottles, Rx only, Manufactured for: Natural Ophthalmics Inc. PO Box 1510 Dillon, CO 80435, NDC 58770-190-42

Washington Homeopathic Products

Class I - Dangerous

An error occurred where the product was manufactured with Potassium Chloride instead of Potassium Phosphate.

Mar 18, 2021 Prescription Drugs View Details →

Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed in the U.S. by Kimberly-Clark Global Sales, LLC, Roswell, GA 30076-2199 Distributed in Canada by Kimberly-Clark Inc., Mississauga, Ontario L5B 3Y5 UPC 0 36000 91592 1

Kimberly-Clark

Class I - Dangerous

Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled as Moisturizing Foam Hand Sanitizer

Feb 1, 2021 Other Drugs Nationwide View Details →

Guanfacine Extended-Release Tablets 2 mg,100-count bottles, Rx Only, Manufactured by: Apotex Inc. Toronto, Ontario Canada M9L 1T9 Manufactured for: Apotex Corp. Weston, Florida 33326, NDC 60505-3928-1, UPC 3 60505 39281 0

Apotex

Class I - Dangerous

Cross Contamination with Other Product: Product is being recalled due to Trace Amounts of Quetiapine Fumarate

Mar 31, 2021 Prescription Drugs Nationwide View Details →

Tremfya (guselkumab) Injection, 100 mg/mL, one single-dose prefilled syringe per carton, Rx only, Manufactured by: Janssen Biotech, Inc., Horsham, PA 19044; NDC 57894-640-01.

Cardinal Health

Class I - Dangerous

Temperature Abuse

Mar 9, 2021 Prescription Drugs View Details →

ZOMA-Jet 10 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 10 mg vial, ZOMA-Jet 10 Demonstration Kit contains -ZOMA-Jet 10 device - 7 Needle-Free Head A's - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 19031 4.

Ferring Pharmaceuticals

Class I - Dangerous

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

Mar 11, 2021 Prescription Drugs Nationwide View Details →

ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACTON (somatropin) for injection 5mg vial, Rx only, ZOMA-Jet 5 Demonstration Kit contains -ZOMA-Jet 5 device - 5 Needle-Free Head A's - 2 Vial Adaptors - 1 Carrying Case - 1 User Manual; Manufactured for: Ferring Pharmaceuticals Inc. Parsippany, NJ 07054; UPC 3 55566 18031 5.

Ferring Pharmaceuticals

Class I - Dangerous

Defective Delivery System: customer complaints concerning the injector pen breaking apart and disintegrating into pieces.

Mar 11, 2021 Prescription Drugs Nationwide View Details →

Acyclovir Sodium Injection 1000mg/20mL (50mg/mL) vial NDC 68382-049-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 20mL Single-Dose Vials per pack NDC 68382-049-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India. Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Crystallization: customer complaints for crystallization in finished product.

Feb 18, 2021 Prescription Drugs Nationwide View Details →

Acyclovir Sodium Injection 500mg/10mL (50mg/mL) vial NDC 68382-048-01, For Intravenous Infusion Only MUST BE DILUTED PRIOR TO USE, packaged in 10 x 10mL Single-Dose Vials per pack NDC 68382-048-10, Rx only, Manufactured by: Cadila Healthcare Ltd., Vadodara, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534.

Zydus Pharmaceuticals (USA)

Class I - Dangerous

Crystallization: customer complaints for crystallization in finished product.

Feb 18, 2021 Prescription Drugs Nationwide View Details →

0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manufactured for ICU Medical, Inc., Lake Forest, Illinois, 60045 USA. NDC 0990-7138-09

ICU Medical

Class I - Dangerous

Presence of particulate matter.one confirmed customer report of particulate matter within two semi-rigid bottles identified prior to use

Mar 9, 2021 Prescription Drugs Nationwide View Details →

Adam's Secret Extra Strength 3000, 840 mg, 10 count blister packs, Distributed by AS Inc., Made in USA, UPC 6 09728 43452 6.

Adams.Secret.co

Class I - Dangerous

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.

Feb 15, 2021 Other Drugs Nationwide View Details →

Omeprazole Delayed Release Capsules, USP, 20 mg, 1000-count bottles, Rx only, Packaged by GSMS Incorporated, Camarillo, CA 93012-8601 USA, NDC 51407-129-10

Golden State Medical Supply

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out of Specification results obtained for unknown impurities during stability testing by manufacturer

Mar 19, 2021 Prescription Drugs View Details →

Adam's Secret Extra Strength 1500, 800 mg, 10 count blister packs, Distributed by KP Inc., Made in USA, UPC 6 09728 43462 5

Adams.Secret.co

Class I - Dangerous

Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of tadalafil and sildenafil.

Feb 15, 2021 Other Drugs Nationwide View Details →

Romidepsin Injecton, 27.5 mg/5.5 mL (5 mg/mL) Rx Only, 5.5 ml vial, Teva Pharmaceuticals USA, Inc. NDC 0703-4004-01

Teva Pharmaceuticals USA

Class I - Dangerous

Failed Impurity/Degradation Specifications: Out-of-specifications results observed for impurities during stability testing.

Mar 4, 2021 Prescription Drugs Nationwide View Details →

Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Manufactured by: Frontida BioPharm, Inc., Philadelphia, PA 19124 USA, Repackaged by: Bryant Ranch Prepack, Inc., Burbank, CA 91504 USA, NDC 63629-1067-01

Bryant Ranch Prepack, Inc.

Class I - Dangerous

Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolactone 25 mg tablets.

Jan 27, 2021 Prescription Drugs Nationwide View Details →

Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose cups per tray, For Institutional Use Only, Rx only, Hi-Tech Pharmacal Co., Inc, Amityville, NY 11701, NDC Tray: 50383-311-07; NDC Unit Dose Cup 50383-311-07

Akorn

Class I - Dangerous

Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed during 6 month stability testing

Mar 8, 2021 Prescription Drugs Nationwide View Details →

Omeprazole Delayed-Release Capsules, USP, 20 mg, 1000 count bottles, Rx Only, distributed by Breckenridge Pharmaceutical, Inc., Berlin, CT, Manufactured by Tow Pharmaceutical Europe, S.L., Martorelles (Barcelona), Spain NDC 51991-643-10

Breckenridge Pharmaceutical

Class I - Dangerous

Failed Impurities/Degradation Specifications: Out-of-Specification results obtained for unknown impurities during stability testing.

Mar 11, 2021 Prescription Drugs Nationwide View Details →