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.
- 2018-05-23FDA-DrugPrescript Pharmaceuticals, Inc.Class IIAcetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pak containers, Rx Only. Mnfct for: Aurobindo Pharma USA, Inc., Dayton, NJ 08810. Mnfct by: Aurolife Pharma LLC, Dayton, NJ 08810. Pckgd by PreScript Pharm Inc. Pleasanton, CA 94566. NDC: 13107-059-99 Bar Code 0078-20-2033
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
- 2018-05-23FDA-DrugPrescript Pharmaceuticals, Inc.Class IIClindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannett Co. Inc., Philadelphia, PA. Mnfct for: Lannett Co. Inc., Philadelphia, PA. Pckgd by PreScript Pharm. Inc. Pleasanton, CA 94566. NC 00527-1382-01, Bar Code 0639-30-176
Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F to 86¿F) which differs from the original manufacturer declaration of; Store at 20¿C to 25¿C (68¿F to 77¿F).
- 2018-05-23FDA-DrugBoiron Inc.Class IIICalendula Cream, calendula officinalis 1X HUS-10%, 2.5 oz. tubes, Distributed by Boiron Inc., Newtown Square, PA
Labeling: Labeling Error on Declared Strength; The outer carton (secondary packaging) statement of ingredients misstates the concentration of active ingredient at 7%. The primary packaging (tube) correctly states the active ingredient at 10%.
- 2018-05-23FDA-DrugSun Pharmaceutical Industries, Inc.Class IISulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-count bottle, Mfg. by: Frontida BioPharm, Inc., 1100 Orthodox St., Philadelphia, PA 19124, Dist, by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512. NDC 53489-146-05
Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg (500 ct.) because a foreign matter identified as polyethylene was detected in two (2) tablets.
- 2018-05-16FDA-DrugAuroMedics Pharma LLCClass IAmpicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular or Intravenous Use, Sterile, Manufactured for: AuroMedics Pharma LLC, 6 Wheeling Road, Dayton, NJ, NDC 55150-117-20.
Presence of Particulate Matter: confirmed customer report of the presence of visible particulate matter believed to be red rubber particles from the manufacturing process of the active ingredients.
- 2018-05-16FDA-DrugNoven Pharmaceuticals, Inc.Class IIMinivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (NDC 68968-6637-1), packaged in 8 pouches per box (NDC 68968-6637-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- 2018-05-16FDA-DrugNoven Pharmaceuticals, Inc.Class IIMinivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC 68968-6610-1), packaged in 8 pouches per box (NDC 68968-6610-8), Rx only, Mfd. by: Noven Pharmaceuticals, Inc., Miami, Florida 33186; Dist. by: Noven Therapeutics, LLC, Miami, Florida 33186.
Defective Delivery System: no longer meets the specification for shear, an attribute related to the adhesive properties of the transdermal patches. As a result, patients could experience patches that do not stick well to the skin.
- 2018-05-16FDA-DrugSeptodont Inc.Class IIIOraVerse (Phentolamine Mesylate) Injection, 0.4 mg/1.7mL, packaged in a box of 10 cartridges of 0.4mg/1.7mL each, Rx only, Distributed by Septodont, Inc., Louisville, CO 80027, Made in Canada by Novocol Pharmaceutical of Canada, Inc., NDC 0362-0101-10
Failed Impurities/Degradation: This recall has been initiated due to an out of specification (OOS) result that was obtained for related substance (Phentolamide), a known degradation product impurity at the 15 month stability test point.
- 2018-05-16FDA-DrugCoast Quality Pharmacy LLCClass IIMacroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggregated and non-Aggregated Human Serum Albumin 2.5-5 mg Sodium Acetate Sol 200 mL/0.125 mL lyophilized powder in 10 mL glass vial, Rx only, AnazaoHealth, Tampa, FL
Lack of Assurance of Sterility
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IILupron Depot 22.5 mg 3 month Kit NDC 00074-3346-03 84 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIKisqali 600 Dose 63 tablet 200 mg NDC 00078-0874-63 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIOPDIVO 40 mg/4 mL SDV NDC 00003-3772-11 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IITasigna Capsules 150 mg NDC 00078-0592-87 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIZarxio 300 mcg/0.5 mL PFS NDC 14 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIPerjeta 420 mg/14 mL SDV Vials 50242-0145-01 21 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IILetrozole 2.5 mg tab NDC 51991-0759-33 30 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIOndansetron 8 mg tablet NDC 57237-0076-30 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIBendeka 25 mg/mL 4 mL MDVPF NDC 63459-0348-04 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IICapecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IICapecitabine 150 mg Tablet NDC 00378-2511-91 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIImatinib Mesylate Tablet 400 mg NDC 60505-2901-03 30 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IISutent 50 mg capsules x28 NDC 00069-0550-38 42 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IISutent 37.5 mg capsules x28 NDC 00069-0830-38 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIDexamethasone 4 mg tablet NDC 49884-0087-01 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IICyclophosphamide 50 mg cap NDC 00054-0383-25 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IISprycel 100 mg tablet NDC 00003-0852-22 30 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IISprycel 80 mg tablet NDC 00003-0855-22 30 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IIGleevec 100 mg tablet NDC 00078-0401-34 30 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IITemozolomide 250 mg NDC 43975-0257-05 28 days supply
Lack of Processing Controls.
- 2018-05-16FDA-DrugKroger Specialty Pharmacy, Inc.Class IITemozolomide 20 mg NDC 43975-0253-05 28 days supply
Lack of Processing Controls.
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