Drug and pharmaceutical recalls
17728 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2018-03-21FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIClocortolone Pivalate Cream, 0.1%, 90-gram tube, Rx only, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08540, Manufactured by: DPT, Laboratories Ltd. San Antonio, TX 78215, NDC 43598-341-90
Failed Stability Specifications:Out-of-specification results observed for viscosity during stability testing.
- 2018-03-21FDA-DrugPfizer Inc.Class IHydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Hospira, Inc., Lake forest, IL 60045 USA. NDC: 0409-2634-01
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- 2018-03-21FDA-DrugPfizer Inc.Class IHydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Single-dose Vial, High Potency Formulation. Mfd For: Teva Parenteral Medicines, Inc., Irvine, CA 92618. NDC: 0703-0110-01
Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty or cracked.
- 2018-03-21FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IISermorelin Acetate, powder, a) 1 GM-bottle (NDC58597-8092-1) b) 5 GM-bottle (NDC 58597-8092-2) c) 10 GM-bottle (NDC 58597-8092-4) API American Pharmaceutical Ingredients
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
- 2018-03-21FDA-DrugAmerican Pharmaceutical Ingredients LLCClass IIOxytocin USP, powder, 1g-bottle, API American Pharmaceutical Ingredients, NDC 58597-7042-3
Stability Data Does Not Support Expiry: Stability data from manufacturer does not support expiration dates listed.
- 2018-03-21FDA-DrugAlva-Amco Pharmacal Companies., Inc.Class IIIPsoriasin Daytime Relief Cream with Vitamin D & Oatmeal, (Coal Tar 1.25%), packagedin 57 g plastic tubes, Distributed by: ALVA-AMCO Pharmacal Cos., Inc., Niles, IL 60714, USA. NDC 52389-745-56, UPC 0 72959 01045 4.
Subpotent Drug: The product has failed to maintain its label claim of coal tar throughout its labeled 24-month expiry period.
- 2018-03-21FDA-DrugSagent Pharmaceuticals IncClass IImethylPREDNISolone Sodium Succinate for Injection, USP, 1 gram* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-810-30.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- 2018-03-21FDA-DrugSagent Pharmaceuticals IncClass IImethylPREDNISolone Sodium Succinate for Injection, USP, 125 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-808-10.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- 2018-03-21FDA-DrugSagent Pharmaceuticals IncClass IImethylPREDNISolone Sodium Succinate for Injection, USP, 40 mg* per vial, Single-Dose Vial, Rx only, Mfd. for: Sagent Pharmaceuticals, Schaumburg, IL 60195 (USA), Made in India. NDC 25021-807-05.
Failed Impurities/Degradation Specifications: High out of specification results for an impurity.
- 2018-03-14FDA-DrugMckesson Packaging ServicesClass IIRANITIDINE Tablets, USP 150 mg UD 100 tablets (10x10), RX Only, Manufactured by: Amneal Pharmaceuticals, Hauppauge, NY 11788, NDC 63739-489-10
Failed Stability Specifications
- 2018-03-14FDA-DrugSCA Pharmaceuticals, LLC.Class IIIlabetalol HCl injection 20 mg/4 mL (5mg/mL), 4 mL syringe, Rx Only, for IV Use, SCA Pharmaceuticals, Windsor, CT 06095 --- NDC 70004-0700-28, UPC 70004070028
Labeling; Incorrect or Missing Lot number/Expiration Date; some product labels incorrectly indicates a compounding date of 12/27/2018 and use-by date of 03/27/2019 instead of 12/27/2017 and use-by-date of 03/27/2018
- 2018-03-14FDA-DrugBella All NaturalClass IBella Capsules, 600mg, 30-count bottles, Manufactured for: Bella All Natural 304 E 11th Street, Los Angeles, CA 90015
Marketed Without An Approved NDA/ANDA: This product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was withdrawn from the U.S. market in October 2010 due to safety concerns, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.
- 2018-03-14FDA-DrugBayer HealthCare Pharmaceuticals, Inc.Class IICoppertone Kids Sunscreen Spray (avobenzone 3%, Homosalate 10%, Octisalate 5%, Octocrylene 4%, Oxybenzone 5%) 8.3 oz. bottle, Dist. by: Bayer Healthcare LLC Whippany, NJ 07981, UPC 41100573636.
Labeling: Label mix-up
- 2018-03-14FDA-DrugAstraZeneca Pharmaceuticals LPClass IIILynparza (olaparib) capsules 50 mg, 112 count bottles, Rx only, Manufactured for: Astra Zeneca Pharmaceuticals LP Wilmington, DE 19850 by: Patheon Pharmaceuticals, Inc. Cincinnati OH 45237 Product of Switzerland NDC 0310-0657-58
Failed Impurities/Degradation Specifications; elevated levels of quality attribute Form L (polymorph).
- 2018-03-14FDA-DrugOxygen Development LlcClass IIILife Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653
Superpotent drug: failed assay throughout the stick after 6 months stability.
- 2018-03-14FDA-DrugSpirit Pharmaceuticals, LLCClass IIIbuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1
CGMP deviations: Ibuprofen is being recalled in response to previous recall
- 2018-03-14FDA-DrugKalchem International, Inc.Class IIVardenafil HCl, USP (trihydrate), 500 GM Part # 330-05, Rx only, For Manufacturing, Repackaging and Processing for Rx and Research Only, Kalchem International, Inc. 224 South Main Street Lindsay, OK 73052 888-298-9905, NDC 60592-330-05
cGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest or expiration date in firm's container/closure system.
- 2018-03-14FDA-DrugOsmotica Pharmaceutical CorpClass IIIMethylphenidate Hydrochloride Extended-release Tablets, USP, 36 mg, 100-count bottle, Rx only, Trigen Laboratories, LLC Bridgewater, NJ 08807. NDC 13811-708-10
Subpotent Drug:100-count product bottle labeled as Methylphenidate HCL ER Tablets 36 mg found to contain 1 27 mg Methylphenidate HCL ER Tablet.
- 2018-03-14FDA-DrugApollo CareClass IIVancomycin 1.25g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-264-25.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
- 2018-03-14FDA-DrugApollo CareClass IIVancomycin 1g added to 250mL of 0.9% Sodium Chloride IV bag, Rx only, APOLLOcare, 3801 Mojave Ct., Suite 101, Columbia, MO 65202, NDC 71170-254-25.
Stability Data Does Not Support Expiry: 90-day beyond use date (BUD) for the affected product is not supported.
- 2018-03-14FDA-DrugAkorn, Inc.Class IIIAtropine Sulfate Ophthalmic 1% Solution, USP, 5mL per bottle, Sterile, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-215-05
Failed Stability Specification: OOS low viscosity results discovered during retain testing.
- 2018-03-14FDA-DrugHospira Inc. A Pfizer CompanyClass IILabetalol Hydrochloride Injection, USP, 100 mg/ 20 mL (5 mg/mL), 20 mL Multidose Vial, Rx only, labeled as a) Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-20; and b) NOVAPLUS, Manufactured by Hospira, Inc., Lake Forest, IL 60045, NDC 0409-2267-25.
Defective Container: Cracked glass at the rim surface of glass vials, covered by the stopper and crimp seal.
- 2018-03-07FDA-DrugAuroMedics Pharma LLCClass ILevofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46
Presence of Particulate Matter; contains visible particulate matter identified as mold.
- 2018-03-07FDA-DrugKareway Products IncClass IGERICARE Eyewash, sterile eye irrigating solution, packaged in a 4 fl oz (118 mL) bottle, OTC, Distributed by Geri-Care Pharmaceuticals Corp., Brooklyn, NY 11204, NDC 57896-0186-04
Non-sterility: confirmed microbial contamination with Achromobacter xylosoxidans
- 2018-03-07FDA-DrugLEADIANT BIOSCIENCES, INCClass IIICystaran (cysteamine ophthalmic solution) 0.44%, 15 mL bottle, Rx only, Manufactured by Hi-Tech Pharmacal Co. Inc., Amityville, NY 11701 for Leadiant Biosciences, Inc., Gaithersburg, MD 20878, NDC 54482-020-01
Subpotent Drug: Out of specification for an active ingredient cysteamine hydrochloride.
- 2018-03-07FDA-DrugB. Braun Medical IncClass II0.9% Sodium Chloride Irrigation USP, 1000 mL Plastic Irrigation Container (PIC), Rx only, B. Braun Medical Inc., Irvine, CA 92614, Catalog # R5200-01, NDC 0264-2201-00.
Presence of Particulate Matter: Customer complaint of particulate matter which has been identified as polyethylene, which is consistent with the material used to manufacture the container cap was received.
- 2018-03-07FDA-DrugFagron, IncClass IISyrSpend SF Suspending Base, a) 500 mL (NDC 51552-1079-5) and b) 4 L (NDC 51552-1079-9), Rx Only, Manufactured by Fagron Inc. St. Paul, MN 55120
Microbial contamination of Non-Sterile Product; product contamination with yeast and mold (Paecilomyces saturatus and Aspergillus fumigatus).
- 2018-03-07FDA-DrugMedline Industries IncClass IIPVP Scrub Solution, Povidone Iodine, 7.5% (equivalent to 0.75% available iodine), 4 FL OZ bottle, Manufactured in USA by Medline Industries, Inc., Northfield, IL 60093; Product Number MDS093945; NDC 53329-938-04
Subpotent Drug: product not meeting the iodine assay level requirements through the labeled expiry.
- 2018-03-07FDA-DrugALLERGANClass IIINFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013.
Failed Stability Specifications: Product stability testing results did not meet specifications for iron content.
- 2018-03-07FDA-DrugApace KY LLCClass IIAcyclovir Tablets, USP, 400 mg, 50 Tablets (5 x 10) unit dose blisters [NDC 50268-061-11] per carton [NDC 50268-061-15], Rx Only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478
Presence of Foreign Tablet/Capsule; cartons labeled to contain Acyclovir tablets may contain Torsemide tablets in some of the blister cavities.
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