Drug and pharmaceutical recalls

17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.

2019-11-20FDA-DrugApotex Inc.Class II
Equate Maximum Strength Ranitidine Tablets, USP 150 mg Acid Reducer 130 Tablets Distributed by Wal-Mart Stores, Inc. Bentonville, AR 72716 a) Twin Pack NDC: 49035-100-07; b) Single Pack NDC: 49035-100-00
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
2019-11-20FDA-DrugApotex Inc.Class II
Walgreens Regular Strength Wal-Zan 75 Ranitidine Tablets, USP 75 mg/Acid Reducer 30 Tablets NDC 0363-1029-03 Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
2019-11-20FDA-DrugApotex Inc.Class II
Walgreens Maximum Strength Wal-Zan 150 Ranitidine Tablets, USP 150 mg/Acid Reducer Distributed By: Walgreen Co., 200 Wilmot RD., Deerfield, IL 60015 a) 200 Tablets NDC 0363-1030-07; b) 24 Tablets NDC 0363-1030-02; c) 95 Tablets NDC 0363-1030-09; d) 65 Tablets NDC 0363-1030-06
GGMP Deviations: Possible contamination with impurity N-nitrosodimethylamine (NDMA).
2019-11-20FDA-DrugNovitium Pharma LLCClass II
Novitium Pharma Ranitidine Capsules 300 mg 100 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-40
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-11-20FDA-DrugNovitium Pharma LLCClass II
Novitium Pharma Ranitidine Capsules 300 mg 30 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-002-10
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-11-20FDA-DrugNovitium Pharma LLCClass II
Novitium Pharma Ranitidine Capsules 150 mg 500 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-40
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-11-20FDA-DrugNovitium Pharma LLCClass II
Novitium Pharma Ranitidine Capsules 150 mg 60 capsules Rx Only Manufactured by: Novitium Pharma LLC 70 Lake Drive, East Windsor, New Jersey 08520 NDC 70954-001-20
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-11-20FDA-DrugLannett Company, Inc.Class II
Lannett Ranitidine Syrup (Ranitidine Oral Solution, USP), 15mg/mL Rx Only Distributed by: Lannett Company, Inc. Philadelphia, PA 19154 NDC 54838-550-80
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-11-20FDA-DrugGolden State Medical Supply Inc.Class II
GSMS: Ranitidine Capsules 300 mg, Rx only, 100 count bottles (NDC 51407-098-01) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-11-20FDA-DrugGolden State Medical Supply Inc.Class II
GSMS: Ranitidine Capsules 150 mg, Rx only, 500 count bottles (NDC 51407-097-05) Manufactured by Novitium Pharma LLC, 70 Lake Drive, East Windsor, New Jersey 08520; Packaged by GSMS, Incorporated, Carmillo, CA 93012 USA.
CGMP Deviations: Presence of NDMA impurity detected in product.
2019-11-13FDA-DrugGreen Lumber Holdings, LLCClass I
Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 capsules, 2618 San Miguel Drive, Suite #296, Newport Beach, CA 92660 (949) 426-8622.
Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tadalafil, an FDA approved drug for the treatment of erectile dysfunction.
2019-11-13FDA-DrugICU Medical IncClass I
0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira, Inc. Lake Forest, IL 60045. NDC 0409-7983-25
Presence of Particulate Matter.
2019-11-13FDA-DrugICU Medical IncClass I
LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045. NDC 0409-7953-03
Presence of Particulate Matter.
2019-11-13FDA-DrugLupin Pharmaceuticals Inc.Class III
Cefdinir for Oral Suspension USP, 125 mg/5mL, packaged in a) 60 mL bottle (NDC 68180-722-20), b) 100 mL bottle (NDC 68180-722-10), Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA
Presence of Foreign substance: identified as a dead ant.
2019-11-13FDA-DrugLupin Pharmaceuticals Inc.Class III
Cefdinir for Oral Suspension USP, 250 mg/5mL,100 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mandideep 462 046 INDIA, NDC 68180-723-10
Presence of Foreign substance: identified as a dead ant.
2019-11-13FDA-DrugLupin Pharmaceuticals Inc.Class III
Cephalexin for Oral Suspension USP, 250 mg/5mL, 200 mL bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc. 111 South Calvert Street, Baltimore, Maryland 21202, United States, Manufactured by: Lupin Limited, Mumbai 400 098 INDIA, NDC 68180-0441-02
Presence of Foreign substance: identified as a dead ant.
2019-11-13FDA-DrugSato Pharmaceutical Inc.Class III
Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) tablets, 150-count bottles, Manufactured by SATO PHARMACEUTICAL CO., LTD., 1-5-27 Motoakasaka Minato-KU Tokyo, Japan; SATO PHARMACEUTICAL, INC., 20695 S. Western Ave., Suite 240, Torrance, CA 90501; NDC 49873-404-01.
Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TRIMIX various strengths to include:a) S-TRIMIX (15MG/1MG/10MCG/ML) MDV: b) S-TRIMIX (18MG/0.6MG/6MCG/ML) MDV INJ: c) S-TRIMIX (24MG/0.89MG/8.9MCG/ML) MDV INJ: d) S-TRIMIX (28.85MG/1.9MG/19.2MCG/ML) MDV: e) S-TRIMIX (30MG/1MG/10MCG/ML) MDV: f) S-TRIMIX (30MG/2MG/25MCG/ML) MDV: g) S-TRIMIX (40MG/3MG/39MCG/ML) MDV INJ: h) S-TRIMIX (PA 60MG/PH 1.25MG/PG 6MCG/ML) MDV INJ: i) S-TRIMIX HYOCTANE (29.4MG/1MG/9MCG/ML) j) S-TRIMIX III (29.4MG/0.98MG/9.8MCG/ML) INJ: k) S-TRIMIX STD (16.67MG/0.58MG
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TRIMIX (29.4MG/0.98MG/9.8MCG/ML) INJ; Rx Only, 5ml glass vial. Red Mountain Compounding Rx
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TRIMIX (40MG/2.5MG/29MCG) MDV INJ; Rx Only, 5ml glass vial, Red Mountain Compounding Rx
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TRIMIX (15MG/0.5MG/16MCG/ML) INJ, Rx Only, 5ML glass vial. Red Mountain Compounding Rx.
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-VIT B COMPLEX INJ SOLN (HP); Rx Only, 30ML glass vial, Red Mountain Compounding Rx
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TESTOSTERONE ULTRA 250MG/ML MDV IN SESAME OIL (TEST CYP 200MG/TEST PROP 25MG/NANDROLONE DECA 25MG) Rx Only, 10ml glass vial Red Mountain Compounding Rx.
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TESTOSTERONE PROPIONATE 100MG/ML MDV IN SESAME OIL, Rx Only, 5ML glass vial, Red Mountain Compounding Rx.
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TEST CYP/PROP 160/40MG/ML MDV IN SESAME OIL; Rx Only, a) 10ml b) 13 ml glass vials, Red Mountain Compounding Rx.
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TEST CYP/PROP/DECA-NAN 250MG/ML (80/10/10) IN SESAME OIL, Rx only, Rx Only, 10ml glass vial. Red Mountain Compounding Rx.
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TEST CYP/PROP 160/40MG/ML MDV IN ETHYL OLEATE; Rx Only, a) 10ml b) 13ml glass vials. Red Mountain Compounding Rx.
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TEST CYP/NAN-DECA 200/50MG/ML MDV IN SESAME OIL; Rx Only, 10ml glass vial. Red Mountain Compounding Rx
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TESTOSTERONE CYP 200MG/ML MDV In SESAME OIL, Rx Only, a) 5ML, b) 10ML, c) 13 ML glass vial, Red Mountain Compounding Rx
Lack of Assurance of Sterility
2019-11-13FDA-DrugFirst Royal Care Co. LLC, dba Red Mountain Compounding PharmacyClass II
S-TEST CYP 200MG/ML MDV IN ETHYL OLEATE OIL, Rx only, a) 5ml, b) 10 ml, c) 13ml glass vials, Red Mountain Compounding Rx.
Lack of Assurance of Sterility

← prevpage 222/588next →

Get notified about new drug recalls

Free weekly digest. We email when a new federal recall in this category — or anything else affecting your household — is published.

Get the Sunday Brief

Get notified about new drug recalls

Explore other recall topics