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.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHCG 20 Day Injection, 2625 Units/4 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHCG 11,000 Units, 30 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIHCG 1,000 U/mL Injection, 30 mL, Vial Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIGentamicin 250 mg/1000 mL Irrigation, 1000 mL, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIGentamicin 120 mg/250 mL 0.9% Sodium Chloride for Irrigation, 30 mL Syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIEstradiol Cypionate 10 mg/mL, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIDMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41 mL syringe, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIDexamethasone 24 mg/mL Injection, 10 mL Vial, Anderson Compounding Pharmacy, 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIVancomycin 125 mg/3mL Inhalation, 3 mL Vial, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIAmphotericin B 0.15% Eye Drops, 2 mL Droppers, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIAtropine 0.01% Eye Drops, 1 mL and 2 mL Dropper, Anderson Compounding Pharmacy 310 Bluff City Hwy, Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugAnderson Compounding Pharmacy, Inc. DBA Anderson Compounding PharmacyClass IIAcetylcysteine 10% Ophthalmic Eye Drop 2 mL droptainer, Anderson Compounding Pharmacy 310 Bluff City Hwy Bristol, TN.
Lack of sterility assurance.
- 2019-04-24FDA-DrugIso-Tex Diagnostics, IncClass IIVolumex (Iodinated I 131 Albumin) Injection USP, 25 uCi per 1 mL syringe, Rx Only, Manufactured for Daxor Corp., NY, NY; By: Iso-Tex Diagnostics, Inc.; NDC 50914-7720-8.
Lack of Assurance of Sterility: environmental monitoring report exceeds limits, therefore sterility cannot be assured.
- 2019-04-24FDA-DrugDr. Reddy's Laboratories, Inc.Class IIDivalproex Sodium Extended-Release Tablets, USP, 250 mg a) 100-count bottle (NDC 55111-0533-01), b) 500-count bottle (NDC 55111-0533-05), Rx only, Mfd. By: Dr. Reddy's Laboratories Limited, Bachupally, - 500 090 INDIA
cGMP deviations: Product was exposed above 50% relative humidity levels during packaging operations.
- 2019-04-24FDA-DrugEstee Lauder IncClass IIIRepairwear Laser Focus Line Smoothing Cream Broad Spectrum SPF 15, packaged in a light green folding carton containing a 50 mL silver jar with a silver cap, Clinique Laboratories, Dist. New York, NY 10022
Defective container: Ineffective seal between the cap and jar of the affected product.
- 2019-04-24FDA-DrugMSM Nutraceuticals, LLCClass IIDr. Berne's MSM DROPS 15% Solution, Net Wt. 30ml/1.014 OZ, Distributed by: Dr. Berne's Whole Heallth Products, 400 Hillsboro Technology Drive, Deerfield BEach, FL 33441 SKU#182 UPC 00854582001036
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- 2019-04-24FDA-DrugMSM Nutraceuticals, LLCClass IIRed Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Naphazolene Chloride, Net Wt. 15ml, 0.15 fl oz., Manufactured by: MSM Nutraceuticals, LLC , UPC 8 54582 00118 0
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- 2019-04-24FDA-DrugMSM Nutraceuticals, LLCClass IIDry Eye, Eye Drops, Active Ingredients: OptiMSM, Glycerin USP, Hyaluronic Acid, Polyethylene Glycon, Net Wt. 15ml, 0.51 fl oz., Manufactured by: MSM Nutraceuticals, LLC, UPC 8 54582 00119 7.
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- 2019-04-24FDA-DrugMSM Nutraceuticals, LLCClass II15% MSM, Eye Drops, Net Wt. 30ml, 1.014 oz., Manufactured by: MSM Nutraceuticals, LLC 2103 West Parkside Lane, Ste.107, Phoenix, AZ 85027, UPC 8 54582 00120 3.
Lack of Assurance of Sterility: Product is not terminally sterialized and not tested per USP 71.
- 2019-04-24FDA-DrugInvaGen Pharmaceuticals, Inc.Class IITestosterone Cypionate Injection, USP, 1000 mg/10 mL (100 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-536-37.
Presence of Particulate Matter.
- 2019-04-24FDA-DrugInvaGen Pharmaceuticals, Inc.Class IITestosterone Cypionate Injection, USP, 200 mg/mL, For IM use only, 1 mL Vial, Single Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-31.
Presence of Particulate Matter.
- 2019-04-24FDA-DrugInvaGen Pharmaceuticals, Inc.Class IITestosterone Cypionate Injection, USP, 2000 mg/10 mL (200 mg/mL), For intramuscular use only, 10 mL Vial, Multiple-Dose, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc., 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise, FL 33323, NDC 69097-537-37.
Presence of Particulate Matter.
- 2019-04-17FDA-DrugAurobindo Pharma USA Inc.Class ILidocaine HCl Injection, USP 1 % 50 mg/5 mL (10 mg/mL), 5mL vial, Rx only, Mrd. in India for: AuroMedics Pharna LLC. E Windsor, NJ 08520 NDC 55150-162-05
Presence of Particulate Matter: One vial was found to contain a hair.
- 2019-04-17FDA-DrugUSA LESS Inc.Class ILEOPARD Miracle Honey packaged in a wooden box, UPC 8 699415 910534, containing 12 sachets 180Gr / 6.36 Oz, each 1 Sachet 15 gr / 0.53 Oz is labeled as LEOPARD Miracle of Honey, UPC 8 699415 912859, Manufactured in Turkey, www leopardhoneytr.com.
Marketed Without An Approved NDA/ANDA: product tainted with undeclared sildenafil, an FDA approved drug for the treatment of male erectile dysfunction. The presence of sildenafil in Leopard Miracle Honey renders it an unapproved drug for which safety and efficacy have not been established and, therefore, subject to recall.
- 2019-04-17FDA-DrugMedi-Physics Inc. dba GE HealthcareClass IIIThallous Chloride TI 201 Injection, Specific Concentration: 37 MBq/mL (1 mCi/mL), Total Activity: 325.6 MBq (8.8 mCi) Volume: 8.8 mL vial, Rx Only, Mfg. by GE Healthcare, Medi-physics, Inc., Arlington Heights, IL 60004. NDC: 17156-299-18
Chemical Contamination: Trace amounts of an impurity was detected in the reagent used to manufacture finished product.
- 2019-04-17FDA-DrugLohxa LLCClass IIPhenobarbital Oral Solution, USP 20 mg/5mL, unit dose cup, Rx Only, Rpkg. By.Lohxa Worcester, MA 01608 NDC 70166-536-02
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
- 2019-04-17FDA-DrugLohxa LLCClass IIBismuth Subsalicylate Oral Suspension 262mg/15mL, unit dose cups, OTC, Rpkg. By.: Lohxa Worcester, MA, NDC 70166-059-01
Labeling: Incorrect or Missing Lot and/or Exp Date - the label contains an incorrect Exp Date.
- 2019-04-17FDA-DrugAVKARE Inc.Class IIITelmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478 --- NDC 42291-795-30
Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)
- 2019-04-17FDA-DrugLupin Pharmaceuticals Inc.Class IIITelmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablet bottle, Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, MD, Manufactured by : Lupin Limited, Goa, INDIA -- NDC 68180-198-06
Failed Impurities/Degradation Specifications; 18 month long term stability study.
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