Drug Recall Enforcement Reports

What are the Drug Enforcement Reports?

All drug recalls are monitored by the Food and Drug Administration (FDA) and are included in the Enforcement Report once they are properly classified. The FDA will determine if a firm's removal or correction actions of a marked product meet the requirements to be considered a "recall". The FDA will also determine the public hazard assessment and a recall classification will be published in the Enforcement Report.

The Drug Enforcement Reports included in this listing was last updated on October 09, 2026 and include a total of 18002 recall reports.

Recall Number	Recall Initiation Date	Product Description	Recall Reason	Recall Firm / Quantity	Recall Classification	Status
D-0266-2017	11-17-2016	L-Arginine HCL 100 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 41 vials	Class II	Ongoing
D-0251-2017	11-17-2016	BiMix Phentolamine/Papaverine 0.06 mg/1.8 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 28 vials	Class II	Ongoing
D-0286-2017	11-17-2016	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 18mcg/1mg/1.8mg/0.02mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 17 vials	Class II	Ongoing
D-0289-2017	11-17-2016	Sermorelin Acetate 15 mg. Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 91 vials	Class II	Ongoing
D-0261-2017	11-17-2016	HCG 5,000 IU Vial. Compounded by Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 4,884 vials	Class II	Ongoing
D-0247-2017	11-17-2016	Amino Acid Recover Eaze (50 ML), Phenylaline (L) 8 mg/ml + Tyrosine (L) 0.45 mg/ml + L-Taurine 0.7 mg/ml. Compounded by Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 105 vials	Class II	Ongoing
D-0307-2017	11-17-2016	Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 347 vials	Class II	Ongoing
D-0252-2017	11-17-2016	BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 5 vials	Class II	Ongoing
D-0313-2017	11-17-2016	TriMix, Alprostadil/Phentolamine/Papaverine 20mcg/2mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 25 vials	Class II	Ongoing
D-0284-2017	11-17-2016	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 5 vials	Class II	Ongoing
D-0275-2017	11-17-2016	Myers Cocktail #5 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg + Folic Acid 1 mg + Vitamin E Succinate 10 IU + Vitamin A Acetate 100 IU/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 21 vials	Class II	Ongoing
D-0265-2017	11-17-2016	IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL), (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 132 vials	Class II	Ongoing
D-0296-2017	11-17-2016	Taurine 50 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 90 vials	Class II	Ongoing
D-0250-2017	11-17-2016	B-Complex (30 ML), (Thiamine HCL 100 mg/Riboflavin-5-Phosphate 2 mg/Pyridoxine HCL 2 mg/Niacinamide 100 mg/Methylcobalamin 300 mcg/ml). Compounded by Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 67 vials	Class II	Ongoing
D-0301-2017	11-17-2016	Testosterone Cypionate/Zinc Gluconate in Sesame Oil, 200 mg/2 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 1,544 vials	Class II	Ongoing
D-0311-2017	11-17-2016	TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 35 vials	Class II	Ongoing
D-0317-2017	11-17-2016	TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 5 vials	Class II	Ongoing
D-0300-2017	11-17-2016	Testosterone Cypionate in Sesame Oil, 200 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 7,168 vials	Class II	Ongoing
D-0257-2017	11-17-2016	GAC, L-Glutamine/L-Arginine/L-Carnitine 25 mg/100 mg/200 mg/mL (30 mL). Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 114 vials	Class II	Ongoing
D-0254-2017	11-17-2016	Calcium Gluconate 10% Injection (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 12 vials	Class II	Ongoing
D-0288-2017	11-17-2016	Sermorelin Acetate 9 mg. Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 54 vials	Class II	Ongoing
D-0246-2017	11-17-2016	Amino Energy Cocktail (30 ML), (Methionine (L) 12.5 mg/Inositol 25 mg/Choline Chloride 25 mg/Methylcobalamin 300 mcg/Carnitine (L) 125 mg/Thiamine HCL 50 mg/Riboflavin-5-Phosphate Sod 5 mg/Niacinamide 20 mg/Pyridoxine HCL 2 mg/Folic Acid 2 mg/Ascorbic Acid 50 mg/Chromium Picolinate 200 mcg/Glutamine (L) 30 mg/Lidocaine HCL 10 mg/mL). Compounded by Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 59 vials	Class II	Ongoing
D-0264-2017	11-17-2016	Infuvite IV (Ascorbic Acid 200 mg+ Vitamin A Acetate 330 IU+Vitamin D3 200 IU+Thiamine HCL 6 mg+Riboflavin-5-Phosphate Sod 3.6 mg+Pyridoxine HCL 6 mg+Niacinamide 40 mg+Dexpanthenol 15 mg+Vitamin 40E Succinate 10 IU+Phytonadione (K1) 150 mcg/5 mL). 30 ML. Compounded by Tri-Coast Pharmacy.	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 161 vials	Class II	Ongoing
D-0287-2017	11-17-2016	Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 260 vials	Class II	Ongoing
D-0253-2017	11-17-2016	BiMix Phentolamine/Papaverine 2 mg/30 mg/mL (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 2 vials	Class II	Ongoing
D-0325-2017	11-17-2016	Vitamin D3 100,000 Unit/mL, in olive oil, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 662 vials	Class II	Ongoing
D-0310-2017	11-17-2016	TriMix, Alprostadil/Phentolamine/Papaverine 10mcg/0.5mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 9 vials	Class II	Ongoing
D-0304-2017	11-17-2016	Testosterone Cypionate/Enanthate/Propionate, 160 mg/20 mg/20 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 882 vials	Class II	Ongoing
D-0298-2017	11-17-2016	Testosterone Cypionate in Sesame, 150 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 400 vials	Class II	Ongoing
D-0260-2017	11-17-2016	Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 367 vials	Class II	Ongoing
D-0306-2017	11-17-2016	Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 13 vials	Class II	Ongoing
D-0291-2017	11-17-2016	Sermorelin Forte 12 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 188 vials	Class II	Ongoing
D-0280-2017	11-17-2016	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 5 vials	Class II	Ongoing
D-0259-2017	11-17-2016	Glutamine 25 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 12 vials	Class II	Ongoing
D-0273-2017	11-17-2016	Methylcobalamin/Folic Acid/Pyridoxine 1 mg/1 mg/50 mg/mL, 1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 99 vials	Class II	Ongoing
D-0277-2017	11-17-2016	Mineral Mix Schrader, Zinc Chloride 5 mg/ml + Vanadium 100 mcg/ml + Manganese HCL 100 mcg/ml + Sodium Molybdate 250 mcg/ml + Strontium Chloride 3 mg/ml + Lithium Citrate 5 mg/ml + Chromium Picolinate 100 mcg/ml + Boron Citrate 1798 mg/ml + Sodium Selenite 200 mcg.ml + Cupric Sulfate 1 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 36 vials	Class II	Ongoing
D-0316-2017	11-17-2016	TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/0.5mg/10mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 13 vials	Class II	Ongoing
D-0299-2017	11-17-2016	Testosterone Cypionate in Grapeseed, 200 mg/mL, (5 ML and 10 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 2,818 vials	Class II	Ongoing
D-0308-2017	11-17-2016	Tri-Amino (Ornithine (L) HCL 100 mg/Arginine HCL 100 mg/Citrulline (L) 100 mg/Lidocaine HCL 10 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 78 vials	Class II	Ongoing
D-0267-2017	11-17-2016	L-Carnitine 250 mg/mL, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 14 vials	Class II	Ongoing
D-0292-2017	11-17-2016	Sermorelin Forte Plus 18 mg (Sermorelin Acetate 6 mg/GHRP-6 6 mg/GHRP-2 6 mg). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 441 vials	Class II	Ongoing
D-0324-2017	11-17-2016	Ultra Slim Shot (Methionine (L) 25mg/Inositol 50mg/Choline Chloride 50 mg/Methylcobalamin 1mg/Carnitine (L) 170mg/Pyridoxine HCL 2mg/Lidocaine HCL 10mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 874 vials	Class II	Ongoing
D-0281-2017	11-17-2016	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/1mg/9mg/0.1mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 2 vials	Class II	Ongoing
D-0315-2017	11-17-2016	TriMix, Alprostadil/Phentolamine/Papaverine 30mcg/1mg/30mg/mL, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 141 vials	Class II	Ongoing
D-0323-2017	11-17-2016	Ultra Cocktail #2 (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25 mg/Methylcobalamin 300mcg/Carnitine (L) 170mg/Thiamine HCL 20mg/Riboflavin-5-Phosphate Sod 2mg/Pyridoxine HCL 2mg/Folic Acid 2mg/Ascorbic Acid 20mg/Chromium Picolinate 66mcg/Lidocaine HCL 10mg/mL), (30 ML and 10 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 123 vials	Class II	Ongoing
D-0321-2017	11-17-2016	Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L) HCL 75 mg + Glutamine (L) 75 mg/ml + Lidocaine HCL 10 mg/mL), (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 79 vials	Class II	Ongoing
D-0302-2017	11-17-2016	Testosterone Cypionate in Sesame Oil, 250 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 1,244 vials	Class II	Ongoing
D-0290-2017	11-17-2016	Sermorelin Forte 6 mg (Sermorelin Acetate 6 mg/GHRP-6 3 mg). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 7 vials	Class II	Ongoing
D-0279-2017	11-17-2016	Pyridoxine HCL 100 mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 3 vials	Class II	Ongoing
D-0274-2017	11-17-2016	Myers Cocktail #4 (Ascorbic Acid 2000 mg + Magnesium Chloride 1000 mg + Calcium Gluconate (Anhydrous) 200 mg + Pyridoxine HCL 100 mg + Dexpanthenol 252 mg + Methylcobalamin 2 mg + Thiamine HCL 100 mg + Riboflavin-5-Phosphate Sod 2 mg/10-mL), (10 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 66 vials	Class II	Ongoing
D-0285-2017	11-17-2016	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 40mcg/2mg/40mg/0.04mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 5 vials	Class II	Ongoing
D-0271-2017	11-17-2016	Lipotropic with MIC (Methionine (L) 12.5mg/Inositol 25mg/Choline Chloride 25mg/L-Carnitine 170 mg + Methylcopalamin 300 mcg + Thiamine HCL 20 mg + Riboflavin-5-Phosphate Sod 2 mg + Niacinamide 20 mg + Pyridoxine HCL 2 mg + Folic Acid 1 mg/Lidocaine HCL 20mg/ml, (30 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 236 vials	Class II	Ongoing
D-0282-2017	11-17-2016	Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/3mg/30mg/200mg/ml, (1 ML). Compounded by Tri-Coast Pharmacy	Lack of Assurance of Sterility	Tri-Coast Pharmacy / 10 vials	Class II	Ongoing
D-0172-2017	11-17-2016	SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE INJECTION, 62.5mg elemental iron/5mL, 10 (5mL vials) per shelf pack, Rx only, Mfd: Hikma Farmaceutica (Portugal,) SA Distributed by: Westward Eatowntown NJ 07724 USA, Shelf pack NDC 0143-9570-10, Unit dose NDC 0143-9570-01 Package NDCs: 0143-9570-01; 0143-9570-10	Subpotent Drug: Product has an an out of specification in iron assay analysis found during 18 month stability testing.	West-Ward Pharmaceuticals Corp. / 5,142 Shelf-packs	Class III	Terminated
D-0152-2017	11-14-2016	Desoximetasone Ointment USP, 0.25%, a) 15 g tubes (NDC 61748-206-15 and b) 60 g tubes (NDC 61748-206-60, Marketed by Versapharm Inc., An Akorn Company, Lake Forest, IL, Manufactured by Hi-Tech, Pharmacal Co, Inc., Amityville, NY	Failed Stability Specifications; out-of specification value for homogeneity / phase separation.	Akorn Inc / a) 62 tubes and b) 91 tubes	Class II	Terminated
D-0210-2017	11-13-2016	Ultimate Body Tox PRO capsules, Proprietary Blend, 350 mg, 45 count bottle, Manufactured for: JSN Health, 305 Broadway, 7th Floor, New York, NY 10007.	Marketed Without An Approved NDA/ANDA: The product contains undeclared sibutramine. The presence of sibutramine, a previously approved controlled substance that was removed from the U.S. market in October 2010 for safety reasons, in this tainted product renders it an unapproved drug for which safety and efficacy have not been established and therefore subject to recall.	Ultimate Body Tox / 25 bottles	Class I	Terminated
D-0140-2017	11-09-2016	L-Cysteine Hydrochloride Injection, USP, 0.5 g/10 mL (50 mg/mL), 10 mL Single Dose Vial (NDC 66758-004-01), packaged in 10 x 10mL Vials per carton (NDC 66758-004-02), Rx only, Manufactured for: Sandoz Inc., Princeton, NJ 08540.	Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.	Sandoz Inc / 18,751 vials	Class II	Terminated
D-0146-2017	11-09-2016	Lactulose Solution, USP, 10 g/15 mL, 15 mL unit dose cups (NDC 66689-039-01), packaged in 15 mL x 50 unit dose cups per case (NDC 66689-039-50), Rx only, Manufactured by VistaPharm, Inc., Largo, FL 33771.	Microbial Contamination of Non-Sterile Products: bulk solution tested positive for the presence of the bacteria, Burkholderia cepacia.	VistaPharm, Inc. / 1497 cases	Class II	Terminated
D-0141-2017	11-09-2016	L-Cysteine Hydrochloride Injection, USP, 50 mg/mL, 50 mL Pharmacy Bulk Package Vials (NDC 66758-005-01), packaged in 5 x 50 mL Vials per carton(NDC 66758-005-02), Rx only, Manufactured for: Sandoz, Inc., Princeton, NJ.	Lack of Assurance of Sterility: a recent FDA inspection at the manufacturing firm raised concerns that the product sterility may be compromised.	Sandoz Inc / 33,624 vials	Class II	Terminated
D-0235-2017	11-08-2016	Techni-Care Surgical Hand Scrub and Patient Preoperative Skin Preparation (3.0% w/v Chloroxylenol), packaged in a) 4 oz. bottles (NDC 46706-201-01), b) 8 oz bottles (NDC 46706-201-02), c) 16 oz. bottles (NDC 46706-201-03), d) 12 oz. pumpette (NDC 46706-201-05), e) 32 oz. bottles (NDC 46706-201-06), OTC, Care-Tech Laboratories, Inc., St. Louis, MO 63139	Labeling: Incorrect or Missing Lot and/or Exp Date - Product is missing or has illegible lot and expiry codes, as well as defective or cracked caps.	Care-Tech Laboratories, Inc. / 106,506 bottles: 1761/4oz.; 241/ 8oz.; 107/12oz.; 439/ 16oz; 241/32 oz.	Class III	Terminated
D-0150-2017	11-07-2016	LEVOXYL(R) (levothyroxine sodium tablets, USP), 200 mcg, 100 count bottles, Rx only, Manufactured and Distributed by: King Pharmaceuticals, Inc., Bristol, TN 37620, NDC 60793-860-01 Package NDCs: 60793-850-10; 60793-850-01; 60793-851-10; 60793-851-01; 60793-852-10; 60793-852-01; 60793-853-10; 60793-853-01; 60793-854-10; 60793-854-01; 60793-855-10; 60793-855-01; 60793-856-10; 60793-856-01; 60793-857-10; 60793-857-01; 60793-858-10; 60793-858-01; 60793-859-10; 60793-859-01; 60793-860-10; 60793-860-01	Superpotent	Pfizer Inc. / 2,666 bottles	Class II	Terminated
D-0147-2017	11-04-2016	Amoxicillin for Oral suspension, USP 400 mg/5 mL, 100 mL (when reconstituted), Rx only, Manufactured by: Hikma Pharmaceuticals, P.O. Box 183400, Amman 11118 - Jordan, NDC 0143-9887-01 Package NDCs: 0143-9886-01; 0143-9886-50; 0143-9886-75; 0143-9887-01; 0143-9887-50; 0143-9887-75	Labeling: Label Error on Declared Strength: Some bottles miss a color coded panel where the strength of the product is typically displayed.	West-Ward Pharmaceuticals Corp. / 32,102 bottles	Class III	Terminated
D-0151-2017	11-03-2016	Diltiazem HCl Extended-release Capsules, USP 120 mg, 100-count bottle (NDC 0378-5220-01), 500-count bottle (NDC 0378-5220-05), Rx Only, Manufactured by: Mylan Pharmaceuticals Inc., Morgantown, WV, 26505 USA	Failed Impurities/Degradation Specifications: OOS results for known compound.	Mylan Pharmaceuticals Inc. / 51,983 extended release capsules	Class III	Terminated
D-0173-2017	11-02-2016	PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 18 mg/0.6 mg/0.006 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.	Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.	Fallon Wellness Pharmacy, L.L.C. / 10 vials	Class II	Terminated
D-0174-2017	11-02-2016	PAPA/PHEN/PROST (papverine/phentolamine/prostaglandin) 30 mg/4 mg/0.04 mg/mL Injection, 1 mL vials, Fallon Wellness Pharmacy LLC, 1057 Troy-Schenectady Rd, Latham, NY 12110.	Lack of Assurance of Sterility: product produced on a day there was an excursion in environmental monitoring data.	Fallon Wellness Pharmacy, L.L.C. / 5 vials	Class II	Terminated
D-0163-2017	11-02-2016	Metformin Hydrochloride Tablets, USP 500 mg, 1000 tablets, Rx Only Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013, India, Distributed by: Ascend Laboratories, LLC, Montvale, NJ NDC 67877-217-10 Package NDCs: 67877-217-01; 67877-217-05; 67877-217-10; 67877-217-33; 67877-217-38; 67877-218-01; 67877-218-05; 67877-218-10; 67877-218-33; 67877-218-38; 67877-221-01; 67877-221-05; 67877-221-10; 67877-221-33; 67877-221-38; 67877-413-01; 67877-413-05; 67877-413-10; 67877-413-33; 67877-413-90; 67877-414-01; 67877-414-05; 67877-414-10; 67877-414-33; 67877-414-90	Presence of Foreign Tablets/Capsules; report of Amlodipine Tablets found in 1000 count bottles of Metformin Hydrochloride Tablets USP	Ascend Laboratories LLC / 1739 bottles	Class II	Terminated
D-0207-2017	11-02-2016	BuPROPion Hydrochloride Extended-Release Tablets (XL), 300 mg, Rx Only, a) 30 count bottles (NDC 68382-354-06) and b) 500 count bottles (NDC 68382-354-05), Manufactured by: Cadila Healthcare LTD. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534 Package NDCs: 68382-354-06; 68382-354-16; 68382-354-05; 68382-354-10; 68382-353-06; 68382-353-16; 68382-353-05; 68382-353-10	Failed Dissolution Specifications; 6 month time point	Zydus Pharmaceuticals USA Inc / 16,356 bottles	Class III	Terminated
D-0171-2017	11-01-2016	Qnasl (beclomethasone dipropionate) Nasal Aerosol 80 Mcg, 50 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-210-13.	Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.	Teva Pharmaceuticals USA / N/A	Class III	Terminated
D-0153-2017	11-01-2016	Fentanyl Citrate Injection, USP, 100 mcg Fentanyl/ 2mL, Single Dose, 50 mcg/mL, Rx only, Hospira, Inc., Lake Forest IL 60045, NDC 0409-4093-32	Lack of Assurance of Sterility: Complaints of broken tips on the ampules.	Hospira Inc. / 797,800 ampules	Class II	Terminated
D-0170-2017	11-01-2016	Qnasl (beclomethasone dipropionate) Nasal Aerosol 40 Mcg, 60 Metered Sprays, Rx only, Manufactured for Teva Respiratory, LLC, Horsham, PA 19044, By: 3M Drug Delivery Systems, Northridge, CA 91324, NDC 59310-206-06 and 59310-206-08 (Physician Samples).	Failed Content Uniformity: Product was out of specification for spray content uniformity obtained during stability testing.	Teva Pharmaceuticals USA / 201, 234 Canisters	Class III	Terminated
D-0223-2017	10-28-2016	Skinny Bee Diet capsules, 500 mg, packaged in a 60-count bottle	Marketed without an approved NDA/ANDA: presence of undeclared sibutramine, desmethylsibutramine (an active metabolite of sibutramine) and phenolphthalein.	Love My Tru Body / 74 bottles	Class I	Terminated
D-0167-2017	10-28-2016	Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-701-10.	CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.	Nationwide Laboratories, LLC / 6,333,669 tablets	Class II	Terminated
D-0166-2017	10-28-2016	Salsalate Tablets, USP, 750 mg, packaged in a) 100 count bottles (NDC 42937-704-10); b) 500 count bottles (NDC 42937-704-18); and c) 1000 count bottles (NDC 42937-704-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.	CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.	Nationwide Laboratories, LLC / 2,514,500 tablets	Class II	Terminated
D-0165-2017	10-28-2016	Salsalate Tablets, USP, 500 mg, packaged in a) 500 count bottles (NDC 42937-703-18); b) 100 count bottles (NDC 42937-703-10); and c) 1000 count bottles (NDC 42937-703-20); Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830.	CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.	Nationwide Laboratories, LLC / 2,882,661 tablets	Class II	Terminated
D-0168-2017	10-28-2016	Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Nationwide Laboratories LLC, Iselin, New Jersey 08830, NDC 42937-702-10.	CGMP Deviations: manufactured under practices which may result in assay or content uniformity failures.	Nationwide Laboratories, LLC / 5,786,653 tablets	Class II	Terminated
D-0148-2017	10-28-2016	KENALOG (Triamcinolone Acetonide) Spray with Spray Tube Topical Aerosol, USP, (0.147 mg/g), 15 g bottle, Physician Sample: Not For Sale, Rx only, RANBAXY, Jacksonville, FL 32257, UPC 3 10631 09335 8.	Failed Stability Specifications: Low Out of Specification results for alcohol content.	Sun Pharmaceutical Industries, Inc. / 326,103 bottles	Class III	Terminated
D-0137-2017	10-27-2016	Bupropion Hydrochloride Extended-Release Tablets, USP (XL), 300 mg, a) 90-count bottle (NDC 68001-264-05), b) 500-count bottle (NDC 68001-264-03) , Rx only, Manufactured by: Cadila Healthcare Limited, Ahmedabad, India For BluePoint Laboratories	Failed Dissolution Specifications: The firm was notified that there was a dissolution out of specification result on the 6 month stability samples.	Amerisource Health Services / a) 15,409 bottles b) 5,128 bottles	Class III	Terminated
D-0159-2017	10-24-2016	AZUPHEN MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-314-10	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 604 bottles	Class II	Terminated
D-0161-2017	10-24-2016	Phenazopyridine Hydrochloride Tablets, USP, 100 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-304-10	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 17,788 bottles	Class II	Terminated
D-0156-2017	10-24-2016	UROLET MB URINARY ANTISEPTIC, ANTISPASMODIC Tablets, Each tablet contains: Methenamine 81.6 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue, 10.8 mg; Hyoscyamine Sulfate, 0.12 mg, (a) 30 count (NDC 35573-302-30) and (b) 100 count bottles (NDC 35573-302-10), Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 11,539 bottles	Class II	Terminated
D-0162-2017	10-24-2016	Phenazopyridine Hydrochloride Tablets, USP, 200 mg, 100 count bottles, Rx only, Manufactured for: Burel Pharmaceuticals, Inc., Richland, MS --- NDC 35573-306-10	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 35,149 bottles	Class II	Terminated
D-0158-2017	10-24-2016	UROPHEN MB URINARY ANTISEPTIC Tablets, Each tablet contains: Methenamine 81.6 mg, Benzoic Acid 9.0 mg, Phenyl Salicylate 36 mg, Methylene Blue 10.8 mg, Hyoscyamine Sulfate 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-307-10	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 823 bottles	Class II	Terminated
D-0160-2017	10-24-2016	Indiomin MB URINARY ANTISEPTIC, ANTISPASMODIC Capsules, Each capsule contains: Methenamine 120 mg, Monobasic Sodium Phosphate 40.8 mg, Methylene Blue, 10 mg; Hyoscyamine Sulfate, 0.12 mg, 100 count, Rx only, Manufactured for: BUREL PHARMACEUTICALS, NDC 35573-315-10	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 795 bottles	Class II	Terminated
D-0155-2017	10-24-2016	Hyolev MB URINARY ANTISEPTIC Tablets, Each tablet for oral administration contains: Hyoscyamine Sulfate 0.12 mg, Methenamine 81 mg, Methylene Blue 10.8 mg, Phenyl Salicylate 32.4 mg, Sodium Phosphate Monobasic 40.8 mg, 90 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-301-90	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 2861 bottles	Class II	Terminated
D-0157-2017	10-24-2016	URAMIT MB URINARY ANTISEPTIC Capsules, Each capsule contains: Methenamine 118 mg, Monobasic Sodium Phosphate 40.8 mg, Phenyl Salicylate 36 mg, Methylene Blue 10 mg, Hyoscyamine Sulfate, 0.12 mg, 100 count bottles, Rx only, Manufactured for: BUREL PHARMACEUTICALS, Richland, MS --- NDC 35573-300-10	CGMP Deviations; deficiencies at the manufacturer may result in assay or content uniformity failures	Burel Pharmaceuticals Inc / 2,771 bottles	Class II	Terminated
D-0124-2017	10-21-2016	Sodium Chloride Ophthalmic Solution, USP, 5%, 15 mL (0.5 fL oz.) bottle, Akorn, Inc., Lake Forest, IL 60045, NDC 17478-623-12.	Subpotent Drug: concentration of product is less than labeled amount.	Akorn Inc / 29,972 bottles	Class II	Terminated
D-0138-2017	10-20-2016	FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 5 oz., Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-05	Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL	CutisPharma, Inc. / 8,748 kits	Class III	Terminated
D-0139-2017	10-20-2016	FIRST Omeprazole 2mg/mL in FIRST PPI Suspension Compounding Kit , 3 OZ, Rx only, Manufactured for CutisPharma Wilmington, MA, NDC# 65628-070-03	Labeling: Label error on declared strength. Package Insert -Error in the Description section of the package insert refers to the strength as 3mg per mL; however it should state 2mg per mL	CutisPharma, Inc. / 5904 kits	Class III	Terminated
D-0145-2017	10-19-2016	Ceftriaxone for Injection, USP, 1 gram, 10 Single use Vials, Rx only, For IM or I.V. Use, Manufactured by: Sandoz GMbH for Hospira Worldwide, Inc., Lake Forest, Il 60045, USA, Made in Austria, NDC 0409-7332-01 Package NDCs: 0409-7337-11; 0409-7337-01; 0409-7338-11; 0409-7338-01; 0409-7332-11; 0409-7332-01; 0409-7335-13; 0409-7335-03	Labeling: Missing Label	Sandoz Inc / 139,430 vials	Class III	Terminated
D-0115-2017	10-19-2016	Invokamet (canagliflozin and metformin HCl) tablets, 150 mg/1,000 mg, 60-count bottle, Rx only, Finished product manufactured by: Janssen Ortho, LLC, Gurabo PR 00778, Manufactured for: Janssen Pharmaceuticals, Inc., Titusville, NJ 08560, NDC 50458-543-60 Package NDCs: 50458-540-60; 50458-540-91; 50458-541-60; 50458-541-91; 50458-542-60; 50458-542-91; 50458-543-60; 50458-543-91; 50458-940-01; 50458-940-02; 50458-941-01; 50458-941-02; 50458-942-01; 50458-942-02; 50458-943-01; 50458-943-02	Labeling: Incorrect or Missing Package Insert - Xarelto prescribing information outserts may be affixed to the exterior of Invokamet bottles in place of the Invokamet prescribing information outsert.	Janssen Ortho L.L.C. / 5346 bottles	Class III	Terminated
D-0224-2017	10-19-2016	Duloxetine Delayed-release Capsules USP 30 mg 30-count bottles, Rx Only, Manufactured by: Inventia Healthcare Private Limited Additional Ambermath M.I.D.C., Ambermath (East) 421506, INDIA, Distributed by: Cipia USA, Inc., Miami, FL 33156, NDC 69097-298-02	Failed Tablet/Capsule Specifications: Capsule shell (s) opening inside the bottle The Initial reports stated one or two capsules in a bottle count of 30s opening. First report came in June 14, 2016. Till date about 22 reports have come in from pharmacies which report two batches 130/16/001 and 130/16/002. Third batch 130/16/003 is not distributed yet, will be recalled from warehouse.	Inventia Healthcare Private Limited / 46,848 delayed-release capsules	Class II	Terminated
D-0142-2017	10-18-2016	Zeasorb AF (miconazole nitrate), 2%, cures most athlete's foot, Net wt. 2.5 OZ (71 g), Manufactured for: Steifel Laboratories, Inc., Research Triangle Park, NC 27709, UPC 0 73462 15065 1; NDC 0145-1506-01	Labeling Not Elsewhere Classified: front labels have the incorrect NDC or 0145-1506-01 instead of the correct NDC of 0145-1506-05 and some back labels have the incorrect indication stating "use for the cure of most jock itch" rather than "use for the cure of most athlete's foot".	GSK Consumer Healthcare / 462,732 bottles	Class III	Terminated
D-0436-2017	10-18-2016	HCG (Chorionic Gonadotropin Lyopholized) II, 1000 unit vial, Rx only, Prepared by Town & Country, Compounding & Consultation Services, 106 Prospect St - 1st FL, Ridgewood, NJ 07459	Subpotent Drug: due to failed potency results of 74% (spec. 80-125%).	Town and Country Compounding and Consultation Services, LLC / 101 vials	Class III	Terminated
D-0144-2017	10-13-2016	AHP NIFEdipine Capsules, 10mg USP, 100 count carton (NDC: 68084-022-01); Individual Blister (NDC: 68084-022-11), Rx Only, Manufactured by: Actavis Elizabeth, LLC, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217	Presence of Foreign Tablets/Capsules	Amerisource Health Services / 5283 cartons (100 capsules per carton = 528,300 capsules)	Class III	Terminated
D-0468-2017	10-13-2016	Olanzapine tablets, USP, 2.5 mg, packaged in a 30-count bottle, Rx only, Mfd: By: Dr. Reddy's Laboratories Limited, Bachupally, India, NDC 55111-163-30 Package NDCs: 55111-163-30; 55111-163-01; 55111-163-05; 55111-163-79; 55111-163-78	Failed impurities/degradation specifications: due to out-of-specification result for the Related Substance Compound C (Impurity 6 - N-Oxide at the 18 month stability station.	Dr. Reddy's Laboratories, Inc. / 5,904 bottles	Class III	Terminated
D-0426-2017	10-12-2016	Testosterone Cypionate 200 mg/mL in Sesame Oil, 4 mL and 5 mL vials, Rx only, For IM injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1709-04	Incorrect/Undeclared Excipient; product description section of testosterone cypionate incorrectly states "in grapeseed oil" instead of "in sesame oil" . The primary panel is correct	Pharm D Solutions, LLC / 4 mL: 510 vials, 5 mL: 486 vials	Class III	Terminated
D-0125-2017	10-12-2016	Succinylcholine Chloride, 20 mg per mL, 200 mg per 10 mL, 10 mL vials, Rx only, PharMEDium Services, LLC, Memphis, TN, NDC 61553-0364-65.	Lack of Assurance of Sterility: A portion of the batch quantity was compounded outside of the firm's process media validation.	Pharmedium Services, LLC / 1550 units	Class II	Terminated
D-0427-2017	10-12-2016	HCG-Vitamin B12 5000 IU-8 mg in 10 mL vial, Rx only, For Sub-Q & IM Injection, Pharm D Solutions, Loop West Houston, TX --- NDA 69699-1723-20	Labeling; Error on Declared Strength; product description incorrectly states HCG 7500 units instead of 5000 units. The primary panel is correct	Pharm D Solutions, LLC / 112 bottles	Class III	Terminated
D-0113-2017	10-06-2016	Persantine (dipyridamole USP) tablets, 75 mg, 100-count bottles, Rx only, Dist. by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0019-01	Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.	Boehringer Ingelheim Pharmaceuticals, Inc. / 2562 bottles	Class II	Terminated
D-0114-2017	10-06-2016	DIPYRIDAMOLE Tablets USP, 75 mg, 100-count bottle, Rx only, Dist. by: Roxane Laboratories, Inc., Columbus, Ohio 43216, NDC 0054-0436-25	Presence of foreign tablets/capsules: 50 mg Persantine tablets were found in a 75 mg Persantine 100-count bottle and 50 mg Persantine tablet was found in a 100 count bottle of 75 mg Dipyridamole.	Boehringer Ingelheim Pharmaceuticals, Inc. / 6400 bottles	Class II	Terminated