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-0170-2019 | 09-10-2018 | Phenol 5% and Glycerin Aqueous Solution 10 mL Injection, Pharm D Solutions, Houston, Texas --- NDC 69699-1431-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 1139 milliliters | Class II | Terminated |
| D-0195-2019 | 09-10-2018 | Trimix T 101 Alprostadil/Papverine/Phentolamine 5.9 mcg/17.65 mg/0.59 mcg per mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1336-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 20 milliliters | Class II | Terminated |
| D-0161-2019 | 09-10-2018 | HCG 3000 Unit Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1738-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 765 vials | Class II | Terminated |
| D-0185-2019 | 09-10-2018 | Sermorelin/GHRP-2/Theanine/Mannitol 15 mg/6 mg/75 mg/300 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1731-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 108 vials | Class II | Terminated |
| D-0166-2019 | 09-10-2018 | Lipo MIC-12 Compound Injectable a) NDC 69699-1603-10; b) 30 mL Stock Solution Compound Injectable NDC 69699-1603-30, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 896 vials; 64000 milliliters | Class II | Terminated |
| D-0171-2019 | 09-10-2018 | Phenol 7% and Glycerin Aqueous Solution 10 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1432-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 630 milliliters | Class II | Terminated |
| D-0152-2019 | 09-10-2018 | Epinepherine 1 mg/1 mL 3 mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-0109-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 945 syringes | Class II | Terminated |
| D-0182-2019 | 09-10-2018 | Sermorelin/GHRP-2 9 mg-6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1728-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 330 vials | Class II | Terminated |
| D-0213-2019 | 09-10-2018 | Testosterone in Grapeseed Oil 200 mg/mL, a) 4 mL, b) 5 mL, c) 10 mL and d) 30 mL Injectable, Pharm D Solutions, Houston, Texas NDC 69699-1702-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / a) 4397, b) 4885 c) 1319, d) 4112 vials | Class II | Terminated |
| D-0144-2019 | 09-10-2018 | Bi-Mix (Papaverine/Phentolamine 150 mg/5 mg) a) Injectable NDC 69699-1760-15; b) (LYO) Powder NDC 69699-1760-15, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 29 vials | Class II | Terminated |
| D-0207-2019 | 09-10-2018 | Trimix T-101 Alprostadil/Phapaverine/Phentolamine 5.9 mcg/17.65 mg/Phentolamine 0.59 mcg per mL Pharm D Solutions, Houston, Texas --- NDC 69699-1366-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 10 milliliters | Class II | Terminated |
| D-0139-2019 | 09-10-2018 | Beta-complex B-1, B-6, B-3, B-12, B-5 100, 2.54 Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1611-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 6000 milliliters | Class II | Terminated |
| D-0137-2019 | 09-10-2018 | Arginine Injections 100 mcg/mL, Pharm D Solutions, Houston, Texas NDC 69699-1414-20 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 7150 milliliters | Class II | Terminated |
| D-0141-2019 | 09-10-2018 | Bi-Mix Injection (Alprostadil 150 mcg/Lidocaine 2 mg/mL), Pharm D Solutions, Houston, Texas --- NDC 69699-1323-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 130 milliliters | Class II | Terminated |
| D-0203-2019 | 09-10-2018 | Trimix ST-1 30PA-1.5PH-50A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1388-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 40 milliliters | Class II | Terminated |
| D-0214-2019 | 09-10-2018 | Testosterone Cypionate/Proprinate 200 mg/10 mg/1 mL 30 mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1745-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 580 vials and 30000 milliliters | Class II | Terminated |
| D-0174-2019 | 09-10-2018 | Prostaglandin E1 40 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1347-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 154 milliliters | Class II | Terminated |
| D-0151-2019 | 09-10-2018 | Epi-Shugarcaine Kit Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1409-60 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 70 bottles | Class II | Terminated |
| D-0173-2019 | 09-10-2018 | Prostaglandin E1 150 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1623-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 193 milliliters | Class II | Terminated |
| D-0168-2019 | 09-10-2018 | Methylcobalamin 1 mg/mL a) 10 mL Injectable NDC 69699-1501-10; b) 30 mL Injectable NDC 69699-1501-30, Pharm D Solutions, Houston, Texas | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 24500 milliliters | Class II | Terminated |
| D-0138-2019 | 09-10-2018 | Ascorbic Acid 500 mg/mL Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1502-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 10000 milliliters | Class II | Terminated |
| D-0159-2019 | 09-10-2018 | HCG 10,000 unit/0.3 gm Mannitol Lyopholized, Pharm D Solutions, Houston, Texas ---- NDC 69699-1711-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 1171 vials | Class II | Terminated |
| D-0157-2019 | 09-10-2018 | HCG Reconstitued 50,000 IU Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1736-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 3 vials | Class II | Terminated |
| D-0212-2019 | 09-10-2018 | Zinc Sulfate 1 mg/mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1418-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 184 vials | Class II | Terminated |
| D-0172-2019 | 09-10-2018 | Phosphate Buffer Solution 0.05 m Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-0912-20 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 1900 milliliters | Class II | Terminated |
| D-0145-2019 | 09-10-2018 | Caffeine and Sodium Benzoate Injection 125 mg/125 mg/mL Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1428-02 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 567 milliliters | Class II | Terminated |
| D-0180-2019 | 09-10-2018 | Sermorelin/GHRP-2 6 mg/6 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1727-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 409 vials | Class II | Terminated |
| D-0165-2019 | 09-10-2018 | Levocarnitine 170 mg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1617-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 3000 milliliters | Class II | Terminated |
| D-0211-2019 | 09-10-2018 | Water Sterile for Injection 250 mL IV Pharm D Solutions, Houston, Texas --- NDC 69699-1407-25 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 12 bags | Class II | Terminated |
| D-0176-2019 | 09-10-2018 | Pyridoxine 100 mg/mL, 30 mL MDV Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1614-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 600 milliliters | Class II | Terminated |
| D-0199-2019 | 09-10-2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/10 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1365-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 715 vials | Class II | Terminated |
| D-0167-2019 | 09-10-2018 | Magnesium 40 gm/ns 1000 mL IV, Pharm D Solutions, Houston, Texas --- NDC 69699-0904-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 4 vials | Class II | Terminated |
| D-0188-2019 | 09-10-2018 | Sterile Water 50 mL Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1421-50 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 10 bags | Class II | Terminated |
| D-0162-2019 | 09-10-2018 | HCG 4000 Unit Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1704-01 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 2737 vials | Class II | Terminated |
| D-0177-2019 | 09-10-2018 | QM-4A Quadmix 5 mL 30 PA-2PH-150A-Atropine 0.4 mg Aqueous Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1342-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 25 milliliters | Class II | Terminated |
| D-0201-2019 | 09-10-2018 | Trimix Papaverine/Phentolamine/Alprostadil 30 mg/1 mg/60 mcg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1367-02 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 430 vials | Class II | Terminated |
| D-0183-2019 | 09-10-2018 | Sermorelin/GHRP-2 9 mg/9 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1715-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 250 vials | Class II | Terminated |
| D-0156-2019 | 09-10-2018 | HCG Lyophilized 5000 IU Injectable Pharm D Solutions, Houston, Texas ---- NDC 69699-1707-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 2219 vials | Class II | Terminated |
| D-0179-2019 | 09-10-2018 | Sermorelin/Ipamorelin 18 mg/15 mg Powder, Pharm D Solutions, Houston, Texas --- NDC 69699-1759-18 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 179 vials | Class II | Terminated |
| D-0140-2019 | 09-10-2018 | Bacteriostatic Water for Injection 10 mL, Pharm D Solutions, Houston, Texas --- NDC 69699-1417-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 285 vials | Class II | Terminated |
| D-0143-2019 | 09-10-2018 | Bi-Mix Injection (Alprostadil 80 mcg/Lidocaine 2 mg/mL) Pharm D Solutions, Houston, Texas --- NDC 69699-1317-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 115 milliliters | Class II | Terminated |
| D-0147-2019 | 09-10-2018 | Calcium Gluconate1% Eyewash 10 mg/mL, 125 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0906-12 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 29 bottles | Class II | Terminated |
| D-0192-2019 | 09-10-2018 | Trimix BM3 Papaverine 60 mg/Phentolamine 4 mg Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1310-03 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 67 milliliters | Class II | Terminated |
| D-0146-2019 | 09-10-2018 | Calcium Gluconate 1% Eyewash Oph. Soln, 10 mg/mL, 1000 mL bottles, Pharm D Solutions, Houston, Texas ---- NDC 69699-0907-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 25 bottles | Class II | Terminated |
| D-0204-2019 | 09-10-2018 | Trimix ST-9B 30 PA-2PH-100A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1344-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 59 milliliters | Class II | Terminated |
| D-0210-2019 | 09-10-2018 | Vigamox Oph. Solution Pharm D Solutions, Houston, Texas --- NDC 69699-0304-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 521 syringes | Class II | Terminated |
| D-0175-2019 | 09-10-2018 | Prostaglandin E1 80 mcg/mL Injectable, Pharm D Solutions, Houston, Texas --- NDC 69699-1337-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 189 milliliters | Class II | Terminated |
| D-0187-2019 | 09-10-2018 | 0.9% Sodium Chloride for Injection, 50 mL bags, Pharm D Solutions, Houston, Texas --- NDC 69699-1426-10 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 12 bags | Class II | Terminated |
| D-0026-2019 | 09-10-2018 | Actoplus met XR (pioglitazone and metformin HCl, extended-release) tablets, 15 mg/1000 mg, Rx Only, 30 tablet bottle, Distributed by: Takeda Pharmaceuticals America, Inc, Deerfield, IL 60015. NDC: 64764-510-30 | Defective Delivery System: tablets may be missing, in whole or in part, the laser drilled holes on the metformin core of the Actoplus met XR tablets. | Takeda Development Center Americas, Inc. / 7,248 bottles | Class II | Terminated |
| D-0209-2019 | 09-10-2018 | Trimix T105 PGE/Phentolamine/Papaverine 10 mcg/30 mg/1 mg Injectable Pharm D Solutions, Houston, Texas --- NDC 69699-1351-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 40 milliliters | Class II | Terminated |
| D-0154-2019 | 09-10-2018 | Glutathione 200 mg/mL Solution, Pharm D Solutions, Houston, Texas --- NDC 69699-1504-30 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 4000 milliliters | Class II | Terminated |
| D-0208-2019 | 09-10-2018 | Trimix T-106 30PA-1PH-25A Aqueous Solution Pharm D Solutions, Houston, Texas --- NDC 69699-1339-05 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 44 milliliters | Class II | Terminated |
| D-0202-2019 | 09-10-2018 | Trimix Papaverine/Phentolamine/Alprostadil/Lidocaine 30 mg/1 mg/175 mcg/1 mg Powder Pharm D Solutions, Houston, Texas --- NDC 69699-1369-02 | Lack of Assurance of Sterility | Pharm D Solutions, LLC / 195 vials | Class II | Terminated |
| D-1207-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches Delivers 0.1 mg/day, a) 2 count and b) 8 count boxes, Rx only, , Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6610-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 213714 boxes of 8 patches and 15927 boxes of 2 patches | Class II | Terminated |
| D-1210-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.075 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6675-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 74908 boxes of 8 patches | Class II | Terminated |
| D-1208-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.05 mg/day, a) 2 count and 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6650-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 149631 boxes of 8 patches and 15809 boxes of 2 patches | Class II | Terminated |
| D-1209-2018 | 09-07-2018 | Minivelle (estradiol transdermal system) Patches, Delivers 0.025 mg/day, 8 count boxes, Rx only, Mfd. by: Noven Pharmaceuticals, Inc. Miami, Florida 33186 Dist. By: Noven Therapeutics, LLC. Miami, Florida 33186 --- NDC 68968-6625-8 Package NDCs: 68968-6625-8; 68968-6637-8; 68968-6650-8; 68968-6675-8; 68968-6610-8 | Defective Delivery System: out of specification results for shear, an attribute related to the adhesive properties of the transdermal patches. | Noven Pharmaceuticals, Inc. / 26217 boxes of 8 patches | Class II | Terminated |
| D-1190-2018 | 09-06-2018 | 0.9% Sodium Chloride Injection USP 50 mL Viaflex container Baxter Healthcare Corporation Deerfield, IL 60015 -- NDC 0338-0049-31 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | cGMP Deviation | Baxter Healthcare Corporation / 5184 bags | Class II | Terminated |
| D-1212-2018 | 09-06-2018 | Bupropion Hydrochloride ER Tablets, USP 150 mg, packaged in a) 90-count bottle (NDC 69097-875-05), Manufactured for: Cipla USA Inc., 1560 Sawgrass Corporate Parkway, Suite 130 Sunrise, FL 33323 b) 90-count bottle (NDC 68001-322-05), For BluePoint Laboratories, Rx only, Manufactured by: InvaGen Pharmaceuticals, Inc. (a subsidiary of Cipla Ltd.) Hauppauge, NY 11788 Package NDCs: 69097-875-02; 69097-875-05; 69097-875-12; 69097-876-02; 69097-876-12; 68001-322-05 | Failed impurities/ degradation specifications: Out-of-specification results were observed in the meta-chlorobenzoic acid impurity in batches 18 months or older from date of manufacture in the 90 count bottle size. | InvaGen Pharmaceuticals, Inc. / 26,496 bottles | Class III | Terminated |
| D-1185-2018 | 09-06-2018 | Pramipexole dihydrochloride extended release tablets, 0.75 mg, packaged in 30-count bottles, Rx only, Manufactured by: Par Pharmaceutical, Chestnut Ridge, NY 10977, NDC 10370-252-11 | Failed impurities/degradation specifications: Finished product contain a known product impurity about current specification levels. | Par Pharmaceutical, Inc. / 16,207 (bottles of 30 tablets) | Class III | Terminated |
| D-1191-2018 | 09-04-2018 | Tizanidine HCl Tablets, USP 2mg, 150-count bottles, Rx Only, Mfd. By: Dr. Reddy's Laboratories Limited Srilakulam - 532 409 INDIA, NDC 55111-179-15, UPC 35511179153 Package NDCs: 55111-179-30; 55111-179-15; 55111-179-03; 55111-179-10; 55111-180-30; 55111-180-15; 55111-180-03; 55111-180-10; 3551117915 | Presence of Foreign Tablets/Capsules: Glimepiride tablet was found in a bottle of Tinzadine Hcl Tablets . | Dr. Reddy's Laboratories, Inc. / 8376 units | Class II | Terminated |
| D-1217-2018 | 09-04-2018 | Synjardy (empagliflozin and metformin hydrochloride) Tablets. 5 mg/1000 mg. Rx only. 180-count bottle. Distributed by: Boehinger Ingelheim (BI) Pharmaceuticals, Inc. Ridgefield, CT 06877. Made in Germany. Marketed by: BI Pharmaceuticals, Inc. Ridgefield, CT 06877 and Eli Lilly and Company Indianapolis IN 46285 NDC 0597-0175-18 Package NDCs: 0597-0159-60; 0597-0159-18; 0597-0159-66; 0597-0175-60; 0597-0175-18; 0597-0175-66; 0597-0180-60; 0597-0180-18; 0597-0180-66; 0597-0168-60; 0597-0168-18; 0597-0168-66 | Cross Contamination With Other Products: | Boehringer Ingelheim Pharmaceuticals, Inc. / 998 180-count bottles | Class II | Terminated |
| D-0002-2019 | 08-31-2018 | NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02 Package NDCs: 58368-002-02 | CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product. | BioLyte Laboratories, LLC / a) 500 sample packs; b) 672 bottles | Class II | Terminated |
| D-1197-2018 | 08-31-2018 | Allergy & Hay Fever Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7011-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 124 bottles | Class II | Terminated |
| D-1193-2018 | 08-31-2018 | Sinus Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7013-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 90 bottles | Class II | Terminated |
| D-1199-2018 | 08-31-2018 | Arthritis Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7042-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 140 bottles | Class II | Terminated |
| D-1198-2018 | 08-31-2018 | Colds & Flu Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7012-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 314 bottles | Class II | Terminated |
| D-1194-2018 | 08-31-2018 | Sore Throat & Laryngitis Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7014-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 420 bottles | Class II | Terminated |
| D-1196-2018 | 08-31-2018 | Muscle & Joint Pain Relief Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7041-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 109 bottles | Class II | Terminated |
| D-1192-2018 | 08-31-2018 | Skin Irritation & Itch Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7002-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 192 bottles | Class II | Terminated |
| D-1195-2018 | 08-31-2018 | Diarrhea Response Homeopathic Formula, 2 FL. OZ. (59.2 mL) per amber glass oral spray bottle, Distributed by Beaumont Bio-Med, Inc., Waukon, IA 52172; NDC 58066-7022-7 | CGMP Deviations: products manufactured by contract manufacturer under conditions that could result in possible microbial contamination. | Beaumont Bio-med, Inc. / 160 bottles | Class II | Terminated |
| D-0008-2019 | 08-30-2018 | Thyroid powder, 4.5 kg foil bag, 5x1 kg foil bags packed in 25 Kg Fiber Drum, Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298, NDC 7807-0170-11 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Alkano Chemicals, Inc / 8 kgs | Class II | Terminated |
| D-0024-2019 | 08-28-2018 | Thyroid, USP (Full Strength) Levothyroxine 112.1 mcg/grain Liothyronine 29.2 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-6580-43 Packaged by: Humco Texarkana, TX 75501 USA | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Humco Holding Group, Inc / 10 kilograms | Class II | Terminated |
| D-0022-2019 | 08-28-2018 | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 1000 grams NDC 0395-8077-43 Packaged by: Humco Texarkana, TX 75501 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Humco Holding Group, Inc / Unknown | Class II | Terminated |
| D-0023-2019 | 08-28-2018 | Thyroid, USP (Porcine) Levothyroxine 36.3 mcg/grain Liothyronine 9.7 mcg/grain Active Pharmaceutical Ingredient Rx Only 100 grams NDC 0395-8077-62 Packaged by: Humco Texarkana, TX 75501 USA | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Humco Holding Group, Inc / Unknown. | Class II | Terminated |
| D-1184-2018 | 08-28-2018 | Argatroban Injection, 250 mg/2.5 mL (100 mg/mL), 2.5 mL Single-use Vial, Rx only, Sterile, Manufactured for: Hospira, Inc, Lake Forest, IL 60045 USA. NDC: 0409-1140-01 | Failed Impurities/Degradation Specifications; Out of specification stability testing results at the 18 month time point | Pfizer Inc. / 1,580 vials | Class III | Terminated |
| D-1205-2018 | 08-27-2018 | MethylPREDNISolone Tablets, USP, 4 mg, 21-count blister pack. Rx Only. Jubilant Cadista Pharmaceuticals Inc. Salisbury, MD NDC 59746-001-03 | Failed Stability Specifications: An out-of-specification result was obtained during 18-month stability testing for assay. | Jubilant Cadista Pharmaceuticals, Inc. / 89,722 blister pack | Class III | Terminated |
| D-0025-2019 | 08-27-2018 | Levonorgestrel and Ethinyl Estradiol Tablets, USP 0.15 mg/0.03 mg, Rx Only, 3 extended-cycle blister packs containing 91 tablets each, Made in India, Manufactured for: Mylan Pharmaceuticals Inc., Morgantown, WV 26505 U.S.A., NDC 0378-7281-53. | Labeling: Not Elsewhere Classified-Incorrect NDC and product name identified on blister packs. | Mylan Pharmaceuticals Inc. / 5,790 cartons (526,890 tablets) | Class III | Terminated |
| D-0003-2019 | 08-27-2018 | Norepinephrine 4 mg (16 mcg/mL) added to 5% Dextrose 250 mL Bag Preservative Free, Rx only, QuVa Pharma, 519 Route 173, Bloombury, NJ 08804, UPC 70092103417. | Subpotent Drug: Product may not have the active ingredient present in the bag. | QuVa Pharma, Inc. / 528 bags | Class I | Terminated |
| D-1189-2018 | 08-27-2018 | Furosemide 100 mg added to 0.9% Sodium Chloride 100 mL Injection, 100 mL Single Dose Container bag, Rx Only, SCA Pharmaceuticals, 8821 Knoedl Ct., Little Rock, AR 72205, 877.550.5059, barcode 70004063032. | Presence of Precipitate: Customer complaint for visible precipitate in product believed to be the active ingredient furosemide. | SCA Pharmaceuticals, Inc. / 1384 bags | Class I | Terminated |
| D-0084-2019 | 08-24-2018 | Cortaid Intensive Therapy Cooling Spray (1% hydrocortisone), 2 FL OZ (59 mL) spray bottle, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875518028 | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident. | Valeant Pharmaceuticals North America LLC / 18,408 bottles | Class II | Terminated |
| D-0085-2019 | 08-24-2018 | Cortaid Maximum Strength Cream (1% hydrocortisone), 1 OZ (28 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875521011 | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident. | Valeant Pharmaceuticals North America LLC / 119,594 tubes | Class II | Terminated |
| D-1183-2018 | 08-24-2018 | Ethosuximide Capsules, USP, 250 mg, 100 capsules per bottle, Rx only, Mfg For VersaPharm Incorporated, Maroerre, GA 30062. Mfg By: Swiss Caps AG, Kirchberg, Switzerland. NDC: 61748-025-01 | Failed Impurities/Degradation Specifications: Out of specification (OOS) results for unspecified impurity. | Akorn, Inc. / 23,788 100-count bottles | Class II | Terminated |
| D-0086-2019 | 08-24-2018 | Cortaid 12-Hour Advanced Anti-itch Cream (1% hydrocortisone), NET WT 1.5 oz. (42 g) tube, OTC, Distributed by: Valeant Pharmaceuticals North America LLC, Bridgewater, NJ 08807, UPC code 301875519155 | CGMP deviations: Notice received from supplier of a voluntary recall of all their nasal products and baby oral gels due to the possibility of microbial contamination. No positive results for the firm's products. were obtained. After the firm review, cGMP deviations ere evident. | Valeant Pharmaceuticals North America LLC / 5,016 tubes | Class II | Terminated |
| D-0296-2019 | 08-24-2018 | Thyroid Powder, USP, 25kg/drum, Rx Only, Sichuan Friendly Pharmaceutical Co., LTD. NDC: 070870-1701-1 | CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | LGM Pharma LLC / 1,307 kg | Class II | Terminated |
| D-0093-2019 | 08-24-2018 | Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00 | CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient. | RemedyRepack Inc. / 2 bottles of 90 tablets (180 tablets) | Class II | Terminated |
| D-1203-2018 | 08-23-2018 | Respitrol, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-003-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 1,869 bottles | Class I | Terminated |
| D-1076-2019 | 08-23-2018 | Cefuroxime 10mg/mL INJ 0.5 mg, SDV, Rx only, Pacific Compounding, Stockton, CA | Presence of Particulate Matter: Particulate matter was reported in one lot of Cefuroxime by a physician after use of product.. FDA analysis identified the particulate as coring of the rubber stopper | Pacific Compounding Pharmacy & Consultations Inc / 41.4 mL | Class II | Terminated |
| D-1200-2018 | 08-23-2018 | Compulsin, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-034-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 989 bottles | Class I | Terminated |
| D-1202-2018 | 08-23-2018 | Thyroveev, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-025-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 370 bottles | Class I | Terminated |
| D-1201-2018 | 08-23-2018 | Neuroveen, Homeopathic (OTC Medicine), 2 fl oz (59 mL) per bottle, Mftd for: HelloLife, Inc. 4635 40th St SE, Grand Rapids, MI 49512. NDC: 49726-015-02 | Microbial Contamination of Non Sterile Products; Products contaminated with microoganisms, including but not limited to Staphylococcus saprophyticus and Burkholderia cepacia | Hellolife / 4,358 bottles | Class I | Terminated |
| D-1214-2018 | 08-23-2018 | Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottle, Rx only, Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore, MD 21202, NDC 43386-541-01 Package NDCs: 43386-540-01; 43386-540-05; 43386-541-01; 43386-541-05; 43386-542-01; 43386-542-05; 43386-543-01; 43386-543-05; 43386-544-01; 43386-544-05 | Failed Impurities/Degradation Specifications: Morphine Sulfate Extended Release Tablets are being recalled due to out of Specification Result noticed for Morphinone Sulfate impurity during 3 month stability analysis and during retain testing. | LUPIN SOMERSET / 4716 bottle | Class III | Terminated |
| D-1169-2018 | 08-23-2018 | Children s Advil Suspension Ibuprofen Oral Suspension, 100 mg per 5mL, 4 FL OZ (120 ml) bottle, Pfizer, Madison, NJ 07940 USA, NDC 0573-0207-30, UPC 3-0573-0207-30-0 Package NDCs: 0573-0174-30; 0573-0171-30; 0573-0171-03; 0573-0171-32; 0573-0170-30; 0573-0170-01; 0573-0170-32; 0573-0290-30; 0573-0290-01; 0573-0207-30; 0573-0232-30 | Labeling Error: Not elsewhere classified. product has a dosage cup marked in teaspoons and the instructions on the label are described in milliliters. | Pfizer Global Supply / 17,136 bottles | Class II | Terminated |
| D-0014-2019 | 08-22-2018 | THYROID POWDER USP (Levothyroxine labeled range of 34.2-41.8mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 8.1-9.9mcg/grain) active pharmaceutical ingredient; 25 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Syntec Pharma Corp / 486 kg | Class II | Terminated |
| D-0013-2019 | 08-22-2018 | THYROID POWDER USP, Full Strength (Levothyroxine labeled range of 103-125mcg/grain; Liothyroine (correct spelling Liothyronine): labeled range of 24.3-29.7mcg/grain) active pharmaceutical ingredient; 5 KG bag, Rx Compounding only, Manu By: Sichuan Friendly Pharmaceutical Co., Ltd., No. 680 Hongpai Road, Neijiang, sichuan 641000, china; Distributed: Syntec Pharma Corp., 96 Gazza Blvd., Farmingdale NY 11735, CAS No. 50809-32-0 | CGMP Deviations: Recall notice received from supplier that Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Syntec Pharma Corp / 2 drums | Class II | Terminated |
| D-1158-2018 | 08-21-2018 | Dexpanthenol injectable, 250 mg/mL, 10 mL Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 91 vials | Class II | Terminated |
| D-1166-2018 | 08-21-2018 | Folic Acid injectable, 10 mg/ml, 30 ml Multiple Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 40 vials | Class II | Terminated |
| D-1157-2018 | 08-21-2018 | Calcium Gluconate injectable, 10%, 50 ml Single Dose vial, Rx only, Central Drugs Compounding Pharmacy, 520 W. La Habra Blvd, La Habra, CA 90631 | Lack of Assurance of Sterility: Inadequate processes and equipment to assure the sterility of products intended to be sterile. | Auro Pharmacies, Inc. / 167 vials | Class II | Terminated |
| D-0006-2019 | 08-21-2018 | Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11 | CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine. | Sichuan Friendly Pharmaceutical Co.,Ltd. / 2662 kg | Class II | Terminated |
| D-1128-2018 | 08-21-2018 | 0.9% Sodium Chloride Injection USP 100 mL bags, Rx only, Baxter Healthcare Corporation Deerfield, IL 60015 USA, NDC 0338-0049-18 Package NDCs: 0338-0049-01; 0338-0049-02; 0338-0049-03; 0338-0049-04; 0338-0049-10; 0338-0049-41; 0338-0049-11; 0338-0049-31; 0338-0049-48; 0338-0049-18; 0338-0049-38; 0338-0043-03; 0338-0043-04 | CGMP Deviations | Baxter Healthcare Corporation / 33600 bags | Class II | Terminated |
