Drug and pharmaceutical recalls
17707 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-759-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, MADE WITH PRIDE & CARE FOR H-E-B SAN ANTONIO, TX 78204. NDC: 37808-759-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walmart, Inc., Bentonville, AR 72716. NDC: 49035-042-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Target Corp., Minneapolis, MN 55403 NDC: 11673-130-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC: 55910-251-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC: 49035-959-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC: 30142-818-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed By Perrigo, Allegan, MI 49010. NDC: 0113-8959-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Dye Free Cherry Flavor Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, DISTRIBUTED BY THE KROGER CO. CINCINNATI, OHIO 45202. NDC: 30142-818-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIInfant's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC: 59779-946-16
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Infant Dye Free Grape Oral Suspension (160mg/5ml), 2 FL OZ (59 mL) per bottle, Distributed by Target Corporation, Minneapolis, MN 55403. NDC: 11673-133-16
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Strawberry Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by: Walgreen Co., 200 Wilmot Rd., Deerfield, IL 60015. NDC: 0363-0971-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIChildren's Cherry Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 45802-203-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIChildren's Grape Flavored Acetaminophen Oral Suspension (160mg/5ml), 4 FL OZ (118 mL) per bottle, Distributed by: Rugby Laboratories, 17177 N Laurel Park Drive, Suite 233, Livonia, MI 48152. NDC: 0536-1321-97
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIChildren's Pain & Fever Bubblegum Flavored Acetaminophen Suspension (160mg/5ml), 4 fl oz (118 mL) per bottle, Distributed by: Wal-Mart Stores, Inc., Bentonville, AR 72716. NDC: 49035-313-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Oral Suspension Grape Flavor, 160 mg per 5 mL, 16 fl oz (473 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 50941-009-43
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIBortezomib, 3.5 mg/vial, Single-Dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-865-60
Failed stability specifications
- 2022-03-02FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAzacitidine, 100mg/vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-465-62
Failed stability specifications
- 2022-03-02FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAzacitidine, 1,00mg/Vial, One Single-dose Vial, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited, Visakhapatnam - 530 046, India, NDC 43598-305-62
Failed stability specifications
- 2022-03-02FDA-DrugPharmasol CorporationClass IILung Cleaner (saline eucalyptus) inhaler, 37 oz cans, Manufactured For: The Lung Cleaner LLC Boulder, CO 80302
cGMP deviations
- 2022-03-02FDA-DrugRISING PHARMACEUTICALSClass IIMethylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx Only, Manufactured for: Rising Pharmaceuticals Inc., Saddle Brook, NJ 07863, NDC 64980-221-01
Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufacturer due to a market complaint, which stated that a tablet in the sealed bottle was twice larger in size when compared to the remaining tablets. This complaint is second of its kind.
- 2022-03-02FDA-DrugProfessional Disposables International, Inc.Class IIPrevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Swabstick, 0.054 fl. oz. (1.6 mL) Each in a pouch, NDC 10819-4077-1; 50 Individual Swabsticks per carton, 10 boxes of 50 Individual Swabsticks per case, REORDER NO. S40750, NDC 10819-4077-4; b) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Individual Swabsticks per case, REORDER NO. S32450, NDC 10819-4077-2; c) One Swabstick, 0.054 fl. Oz. (1.6 mL) Each in a pouch, 500 Ind
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
- 2022-03-02FDA-DrugProfessional Disposables International, Inc.Class IIPrevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v and 70% v/v, packaged as a) One Swab, 0.034 fl. Oz. (1 mL) Each in a pouch, 100 Individual Swabs per carton, 10 boxes of 100 Individual Swabs per case, REORDER NO. B10800, NDC 10819-1080-1; b) One Swab, 0.034 fl. oz. (1 mL) Each in a pouch, 3000 Individual Swabs per case, REORDER NO. B11400, NDC 10819-1080-2; Professional Disposables International, Inc., Orangeburg, NY 10962-1376.
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
- 2022-03-02FDA-DrugProfessional Disposables International, Inc.Class IIPrevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.15% w/v and 70% v/v, packaged as a) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 30 Individual Maxi Swabsticks per carton, 10 boxes of 30 Individual Swabsticks per case, NDC 10819-4076-4, REORDER NO. S41950; b) One Maxi Swabstick, 0.172 fl. Oz. (5.1 mL) Each in a pouch, 300 Individual Swabsticks per case, NDC 10819-4076-3, REORDER NO. S27350; Professional Disposables International, Inc., Orangeburg, NY 1
cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufacture the products.
- 2022-03-02FDA-DrugBayCare Integrated Service Center, LLC /dba BayCare Central PharmacyClass IIINorepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx only, BayCare Central Pharmacy 7802 E. Telecom Parkway Temple Terrace, FL 33637 (813) 901-6392
Subpotent drug
- 2022-02-23FDA-DrugTeligent Pharma, Inc.Class IIErythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, Distributed by: McKesson Corporation, dba Sky Packaging, 4971 Southridge Blvd., Suite 101, Memphis, TN 38141, NDC 63739-053-66.
Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Related Compounds.
- 2022-02-23FDA-DrugRevive Rx LLC dba Revive Rx PharmacyClass IHCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only, Not For IV Use, Vial, Rx Only, Compounded By: Revive Rx 3831 Golf Dr., Houston, TX 77018, NDC: 88888-1739-01.
Non-sterility; bacterial contamination identified as Paenibacillus lautus.
- 2022-02-23FDA-DrugCooperSurgical, IncClass IPARAGARD T380A (intrauterine copper contraceptive), 1 unit per carton together with an insertion tube and solid white rod in a Tyvek polyethylene pouch, Rx Only, Manufactured by Teva Women's Health Inc. a subsidiary of Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 51285-204-01
Non-sterility
- 2022-02-23FDA-DrugCelebrate TodayClass IRED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN B00KA8FBNI, barcode X001ANE0I5.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tadalafil, ingredients found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- 2022-02-23FDA-DrugSTAQ Pharma, Inc.Class IMorphine Sulfate PF 25 mg/25mL (1 mg/mL) in NaCl, 25 mL in 30 mL Single Dose Syringe, Rx only, STAQ Pharma, Inc., Denver, CO 80239, NDC: 73177-0105-04.
Labeling: Label Mix up; A limited number of syringes containing HYDROmorphone HCl PF were incorrectly labeled as Morphine Sulfate PF with lot number 21104221A
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