Drug and pharmaceutical recalls
17732 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2016-05-04FDA-DrugMckesson Packaging ServicesClass IIISKY Aspirin Chewable Tablets, 81 mg, Unit Dose 750 tablets (25 x 30) box, OTC, Distributed by: McKesson Packaging Service, Concord, NC 28027, NDC 63739-434-01.
Labeling: Label mix-up -outer carton incorrectly labeled as aspirin chewable tablets.
- 2016-04-27FDA-DrugAbbVie Inc.Class IIIZemplar (paricalcitol) capsules, 1 mcg, 30-count bottle, Rx Only, Mfd for AbbVie Inc. North Chicago, IL 60064, NDC 0074-4317-30.
Failed Content Uniformity Specifications
- 2016-04-27FDA-DrugHospira Inc.Class IIPotassium Chloride Injection 20 mEq, 400 mEq/L, Packaged in 50 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7077-14
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIMannitol I.V., 20%, USP (20 g/ 100 mL), Packaged in 250 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-7715-02, Barcode (01) 0 030409 771502 2
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIAminosyn-PF (amino acids) 7%, Sulfite-Free, 500 mL Bags, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC: 0409-4178-03 Barcode (01) 0 030409 417803 5
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIDextrose Injection, USP, 20%, Packaged as 500 mL in 1000 mL Bags, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7935-19, Barcode (01) 0 030409 793519 2
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIDextrose Injection, USP, 50%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7936-19, Barcode (01) 0 030409 793619 9
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugHospira Inc.Class IIDextrose Injection, USP, 70%, Packaged as 500 mL in 1000 mL Bag, Rx only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7918-19, Barcode (01) 0 030409 791819 5
Chemical Contamination: Potential for contamination of the products with an aromatic hydrocarbon resin.
- 2016-04-27FDA-DrugImpax Laboratories, Inc.Class IIDextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10
Failed Impurities/Degradation Specifications
- 2016-04-27FDA-DrugImpax Laboratories, Inc.Class IIDextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10
Failed Impurities/Degradation Specifications
- 2016-04-27FDA-DrugTorrent Pharmaceuticals LimitedClass IIITelmisartan Tablets, USP, 80 mg, 30-count (3 x 10 unit-dose blisters) per carton, Rx only, Manufactured by: Torrent Pharmaceuticals LTD., Indrad-382 721, Dist. Mehsana, INDIA.; For: Torrent Pharma Inc., 150 Allen Road, Suite 102, Basking Ridge, NJ 07920, NDC 13668-158-72, UPC 3 13668 158 72 4.
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet.
- 2016-04-20FDA-DrugAmerisource Health ServicesClass IIIFenofibrate Capsules (Micronized), 200 mg , 30-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217 Carton of 30:NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2016-04-20FDA-DrugAmerisource Health ServicesClass IIIFenofibrate Capsules (Micronized), 134 mg Capsules, 20-count Unit Dose Blister Packs per carton, Rx Only, Packaged and Distributed by: American Health Packaging Columbus, Ohio 43217, Carton of 20: NDC 68084-835-32, Individual Dose: NDC 68084-835-33.
Labeling: Incorrect or Missing Lot and/or Exp Date
- 2016-04-20FDA-DrugImpax Laboratories, Inc.Class IIIFenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2016-04-20FDA-DrugImpax Laboratories, Inc.Class IIIFenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02
Labeling: Incorrect or Missing Lot and/or Exp. Date
- 2016-04-20FDA-DrugFresenius Kabi USA, LLCClass IICisatracurium Besylate Injection, 20 mg per 10 mL (2 mg per mL), For intravenous injection, 10 mL Multiple Dose Vial, Rx only, Fresenius Kabi USA, LLC Lake Zurich, IL 60047, NDC 63323-417-10
Incorrect/ Undeclared Excipient: Firm is recalling product due to an incorrect statement of Preservative free on the individual carton label. The vial label and outer carton label contain the correct statement of 0.9% benzyl alcohol added as a preservative.
- 2016-04-20FDA-DrugFresenius Kabi USA, LLCClass IIIHaloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01.
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result.
- 2016-04-20FDA-DrugBiocon IncClass IIISimvastatin Tablets, USP 5 mg Rx only, a) 90 count (NDC 24658-0300-90) and b) 1000 count (NDC 24658-0300-10 )bottles, Manufactured by: Blu Caribe Dorado PR 00646, Manufactured for: Blu Pharmaceuticals Franklin, KY 42134
Subpotent Drug
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 5 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-743-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 30 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-749-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 20 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-748-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugActavis Elizabeth LLCClass IIDextroamphetamine Saccharate, Amphetamine Aspartate, Dextroamphetamine Sulfate, and Amphetamine Sulfate Tablets, 10 mg, 100 ct. bottle, Rx Only. Manufactured by: Actavis Elizabeth LLC, Elmora Avenue, Elizabeth, NJ 07207. Distributed by: Actavis, Inc., 80 Columbia Road, Bldg B, Morristown, NJ 07960. NDC: 45963-745-11.
Failed Impurities/Degradation Specifications: Out of specification for impurities.
- 2016-04-13FDA-DrugJubilant Draximage IncClass IIISODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05
Labeling: Label Error on Declared Strength
- 2016-04-13FDA-DrugApace KY LLCClass IIIMinocycline Hydrochloride Capsules USP, 100 mg*, 30 Capsules (3 x 10) Unit Dose blisters (NDC 50268-569-11, barcode 5026856911) per carton (NDC 50268-569-13, barcode 5026856913), Rx only, Manufactured for: AvKARE, Inc., Pulaski, TN 38478.
Labeling: Incorrect or Missing Lot and/or Exp Date: the individual blisters are mislabeled with an incorrect lot number of 13560 rather than the correct lot number of 13650.
- 2016-04-13FDA-DrugPurdue Pharma L.P.Class IIIIntermezzo (zolpidem tartrate) sublingual tablet 1.75 mg, CIV, 30 Ct Cartons, Rx Only. Dist by Purdue Pharma L.P., Stamford, CT 06901-3431. NDC: 59011-256-30.
Failed Dissolution Specifications
- 2016-04-13FDA-DrugBio-pharm, Inc.Class IIIRanitidine Syrup (Ranitidine Oral Solution, USP), 15 mg/mL (75 mg/5 mL), 16 fl oz Bottle, Rx only, Mfd For: Heritage Pharmaceuticals Inc., Eatontown, NJ 07724, NDC 23155-291-51
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 2 (Papaverine 9 mg, Phentolamine 1 mg, Atropine 0.1 mg, PGE 10 mcg/mL), 5 mL vials, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Lack of Assurance of Sterility: incomplete or missing data regarding production.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 3 (Papaverine 20 mg, Phentolamine 3 mg, Atropine 0.2 mg, PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
- 2016-04-13FDA-DrugMeditech Laboratories, IncClass IIFormula 1 (Papaverine 1.8 mg, Phentolamine 0.2 mg, Atropine 0.02 mg, PGE 18 mcg/mL) Injection, 5 mL vial, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102.
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date.
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