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.
- 2022-03-02FDA-DrugPositive HealthClass IRISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton, ASIN B08JCWG84D, barcode X002NI8PE1.
Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- 2022-03-02FDA-DrugDr. Reddy's Laboratories, Inc.Class IIISapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual packets per carton, Rx Only, Dr. Reddy's, Distributor: Dr. Reddy's Laboratories Inc., Princeton, NJ 08540, Made in India, NDC: 43598-477-11 (packet), 43598-477-30 (carton).
Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride powder 100mg.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-989-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISinus Severe, Oxymetazoline HCl 0.05% Nasal Decongestant with Menthol, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-696-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IINo Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: Walmart Inc., Bentonville, AR 72716. NDC 49035-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IINo Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC, ELK GROVE VILLAGE, IL 60007. NDC 36800-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IINo Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-703-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IINo Drip Nasal Decongestant, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-801-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6319-1
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DIST. BY MEIJER DISTRIBUTION, INC., GRAND RAPIDS, MI 49544. NDC 41250-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISoothing 12 Hour Nasal Decongestant Spray No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed By MAJOR PHARMACEUTICALS, 17177 N Laurel Park Drive, Suite 233 Livonia, MI 48152. NDC 0904-6761-30
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IINasal Spray Decongestant, No Drip, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY THE KROGER CO., CINCINNATI, OHIO 45202. NDC 30142-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaxiumum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY OLD EAST MAIN CO., 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-623-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IINo Drip Nasal Mist, Oxymetazoline HCl 0.05% Nasal decongestant, 1 FL Oz (30 mL) per bottle, Distributed by: CVS Pharmacy, Inc., One CVS Drive, Woonsocket, RI 02895. NDC 59779-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC, 410 TERRY AVENUE N. SEATTLE, WA 9810. NDC 72288-388-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY TOPCO ASSOCIATES LLC., ELK GROVE VILLAGE, IL 60007. NDC 36800-907-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Dist. by Target Corp., Mpls., MN 55403. NDC 11673-935-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, Distributed by SUPERVALU INC., Eden Prairie, MN 55344 USA. NDC 41163-343-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: BETTER LIVING BRANDS LLC, P.O. BOX 99, PLEASANTON, CA 94566-0009. NDC 21130-813-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: RITE AID, 30 HUNTER LANE, CAMP HILL, PA 17011. NDC 11822-6378-1
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion No Drip Nasal Spray Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY DOLGENCORP, LLC, 100 MISSION RIDGE, GOODLETTSVILLE, TN 37072. NDC 55910-511-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05%, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY FOODHOLD U.S.A., LLC, LANDOVER, MD 20785. NDC 41520-108-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IISevere Congestion Nasal Spray, No Drip Plus Menthol, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, Packaged by Perrigo Company for: Big Lots Stores, Inc., P.O. Box 28523, Columbus, OH 43228-0523. NDC: 50594-719-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIMaximum Strength Plus Menthol No Drip Nasal Spray, Oxymetazoline HCl 0.05% Nasal Decongestant, 1 FL Oz (30 mL) per bottle, DISTRIBUTED BY: AMAZON.COM SERVICES LLC 410 TERRY AVENUE N.SEATTLE, WA 98109. NDC: 72288-703-10
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
- 2022-03-02FDA-DrugPerrigo Company PLCClass IIAcetaminophen Child Bubble Gum Flavored Oral Suspension (160 mg/5 ml), 4 FL OZ (118 mL) per bottle, Distributed by Perrigo, Allegan, MI 49010. NDC: 0113-0020-26
CGMP Deviations: Products were manufactured with contaminated excipient that was recalled from the excipient supplier.
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