Showing 12,281–12,300 of 17,974 drug recalls
Drug Recall
Terminated
Historical record Class II
Dextroamphetamine Sulfate Tablets USP, 5 mg, 100-count bottle, Rx only, Manufactured and Distributed by: CorePharma, LLC, Middlesex, NJ 08846, NDC 64720-215-10 by Impax Laboratories, Inc.
Reason
Failed Impurities/Degradation Specifications Recall initiated
March 14, 2016 Reported by FDA
April 27, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Dextroamphetamine Sulfate Tablets USP, 10 mg, 100-count bottle, Rx only, Manufactured and Distributed by: Corepharma, LLC, Middlesex, NJ 08846, NDC 64720-0216-10 by Impax Laboratories, Inc.
Reason
Failed Impurities/Degradation Specifications Recall initiated
March 14, 2016 Reported by FDA
April 27, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class III
Telmisartan 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. by Torrent Pharmaceuticals Limited
Reason
Presence of Foreign Substance: Product complaint for the presence of foreign matter identified as silicone within the tablet. Recall initiated
February 25, 2016 Reported by FDA
April 27, 2016 Distribution
Nationwide
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Drug Recall
Terminated
Historical record Class III
Fenofibrate 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. by Amerisource Health Services
Reason
Labeling: Incorrect or Missing Lot and/or Exp Date Recall initiated
March 31, 2016 Reported by FDA
April 20, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class III
Fenofibrate 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. by Amerisource Health Services
Reason
Labeling: Incorrect or Missing Lot and/or Exp Date Recall initiated
March 31, 2016 Reported by FDA
April 20, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class III
Fenofibrate Capsules (Micronized) 200 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0533-02 by Impax Laboratories, Inc.
Reason
Labeling: Incorrect or Missing Lot and/or Exp. Date Recall initiated
March 17, 2016 Reported by FDA
April 20, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class III
Fenofibrate Capsules (Micronized) 134 mg, 500-count bottle, Rx Only, Distributed by Impax Generics, Hayward, CA 94544, NDC 0115-0522-02 by Impax Laboratories, Inc.
Reason
Labeling: Incorrect or Missing Lot and/or Exp. Date Recall initiated
March 17, 2016 Reported by FDA
April 20, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Cisatracurium 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 by Fresenius Kabi USA, LLC
Reason
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. Recall initiated
April 5, 2016 Reported by FDA
April 20, 2016 Distribution
Nationwide and Puerto Rico
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Drug Recall
Terminated
Historical record Class III
Haloperidol Decanoate Injection, 50 mg/mL, 1 mL vial, Rx Only. Fresenius Kabi USA LLC, Lake Zurich, IL 60047, NDC 63323-469-01. by Fresenius Kabi USA, LLC
Reason
Failed Impurities/Degradation Specifications: Firm is recalling product due to an impurity out-of-specification result. Recall initiated
April 7, 2016 Reported by FDA
April 20, 2016 Distribution
Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical record Class III
Simvastatin 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 by Biocon Inc
Reason
Subpotent Drug Recall initiated
March 24, 2016 Reported by FDA
April 20, 2016 Distribution
PA, CA, & OH
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Drug Recall
Terminated
Historical record Class II
Dextroamphetamine 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. by Actavis Elizabeth LLC
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities. Recall initiated
February 16, 2016 Reported by FDA
April 13, 2016 Distribution
US: Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Dextroamphetamine 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. by Actavis Elizabeth LLC
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities. Recall initiated
February 16, 2016 Reported by FDA
April 13, 2016 Distribution
US: Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Dextroamphetamine 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. by Actavis Elizabeth LLC
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities. Recall initiated
February 16, 2016 Reported by FDA
April 13, 2016 Distribution
US: Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Dextroamphetamine 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. by Actavis Elizabeth LLC
Reason
Failed Impurities/Degradation Specifications: Out of specification for impurities. Recall initiated
February 16, 2016 Reported by FDA
April 13, 2016 Distribution
US: Nationwide
View recall →
Drug Recall
Terminated
Historical record Class III
SODIUM IODIDE I 131 CAPSULE, USP DIAGNOSTIC ORAL , Rx only, Manufactured by Jubilant DraxImage, Inc., Kirkland, QC, Canada, NDC 65174-461-05 by Jubilant Draximage Inc
Reason
Labeling: Label Error on Declared Strength Recall initiated
March 11, 2016 Reported by FDA
April 13, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class III
Minocycline 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. by Apace KY LLC
Reason
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. Recall initiated
February 12, 2016 Reported by FDA
April 13, 2016 Distribution
All product was shipped to KY and further distributed Nationwide
View recall →
Drug Recall
Terminated
Historical record Class III
Intermezzo (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. by Purdue Pharma L.P.
Reason
Failed Dissolution Specifications Recall initiated
March 31, 2016 Reported by FDA
April 13, 2016 Distribution
U.S. Including: FL, LA, MI, MS, NC, NJ, OH and SC.
View recall →
Drug Recall
Terminated
Historical record Class III
Ranitidine 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 by Bio-pharm, Inc.
Reason
Failed Impurities/Degradation Specifications: Product recalled due to elevated impurity result detected during routine stability testing. Recall initiated
December 17, 2015 Reported by FDA
April 13, 2016 Distribution
Nationwide and Puerto Rico
View recall →
Drug Recall
Terminated
Historical record Class II
Formula 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. by Meditech Laboratories, Inc
Reason
Stability Does Not Support Expiry: manufactured with an active ingredient that expired before the labeled Beyond Use Date. Recall initiated
March 14, 2016 Reported by FDA
April 13, 2016 Distribution
Nationwide
View recall →
Drug Recall
Terminated
Historical record Class II
Formula 0 (PGE 20 mcg/mL) Injection, 5 mL vials, Rx only, Meditech Laboratories, Inc., 3200 Polaris Ave., Suite 27, Las Vegas, NV 89102. by Meditech Laboratories, Inc
Reason
Lack of Assurance of Sterility: incomplete or missing data regarding production. Recall initiated
March 14, 2016 Reported by FDA
April 13, 2016 Distribution
Nationwide
View recall →
Data last updated: September 26, 2026 ET
This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace
does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice --
always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take.
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