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 August 07, 2026 and include a total of 17860 recall reports.
| Recall Number | Recall Initiation Date | Product Description | Recall Reason | Recall Firm / Quantity | Recall Classification | Status |
|---|---|---|---|---|---|---|
| D-0695-2018 | 01-11-2018 | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India Package NDCs: 53943-292-15; 53943-292-12; 53943-292-14; 53493-292-12; 53493-292-14 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Time-Cap Laboratories, Inc. / N/A | Class II | Terminated |
| D-0685-2018 | 01-11-2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India Package NDCs: 49483-114-50; 49483-114-10; 49483-114-17; 49483-114-73; 49483-601-00; 49483-601-05; 49483-601-01; 49483-601-50; 49483-601-10; 49483-600-05; 49483-600-01; 49483-600-50; 49489-601-10 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Time-Cap Laboratories, Inc. / N/A | Class II | Terminated |
| D-0689-2018 | 01-11-2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India Package NDCs: 49483-602-01; 49483-602-50; 49483-603-03; 49483-603-50; 49483-603-05; 49483-603-01; 49483-604-01; 49483-604-50; 49483-604-05; 49483-604-03 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Time-Cap Laboratories, Inc. / N/A | Class II | Terminated |
| D-0694-2018 | 01-11-2018 | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India Package NDCs: 49483-114-50; 49483-114-10; 49483-114-17; 49483-114-73; 49483-601-00; 49483-601-05; 49483-601-01; 49483-601-50; 49483-601-10; 49483-600-05; 49483-600-01; 49483-600-50; 49483-600-00 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Time-Cap Laboratories, Inc. / N/A | Class II | Terminated |
| D-0692-2018 | 01-11-2018 | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India Package NDCs: 49483-602-01; 49483-602-50; 49483-603-03; 49483-603-50; 49483-603-05; 49483-603-01; 49483-604-01; 49483-604-50; 49483-604-05; 49483-604-03 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Time-Cap Laboratories, Inc. / N/A | Class II | Terminated |
| D-0687-2018 | 01-11-2018 | Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India Package NDCs: 49483-602-01; 49483-602-50; 49483-603-03; 49483-603-50; 49483-603-05; 49483-603-01; 49483-604-01; 49483-604-50; 49483-604-05; 49483-604-03 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Time-Cap Laboratories, Inc. / N/A | Class II | Terminated |
| D-0583-2018 | 01-10-2018 | Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit Pharmaceuticals, LLC Ronkonkoma, NY 11779, NDC 68210-0800-1 Package NDCs: 68210-0800-1; 68210-0800-4 | CGMP deviations: Ibuprofen is being recalled in response to previous recall | Spirit Pharmaceuticals, LLC / 144 bottles | Class II | Terminated |
| D-0594-2018 | 01-10-2018 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured for Camber Pharmaceuticals, Inc. Piscataway, NJ 08854, By; Hetero Hetero Labs Limited Unit V Polepallly Jadcheria Mahaboob Nagar - 509 301 India, NDC 31722-827-30 Package NDCs: 31722-820-30; 31722-820-01; 31722-820-31; 31722-820-32; 31722-820-05; 31722-827-30; 31722-827-01; 31722-827-31; 31722-827-32; 31722-827-05; 31722-819-30; 31722-819-01; 31722-819-31; 31722-819-32; 31722-819-05; 31722-828-30; 31722-828-01; 31722-828-31; 31722-828-32; 31722-828-05; 31722-829-30; 31722-829-01; 31722-829-31; 31722-829-32; 31722-829-05; 31722-830-30; 31722-830-01; 31722-830-31; 31722-830-32; 31722-830-05 | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. | Hetero Labs, Ltd. - Unit III / 3000 bottles | Class II | Terminated |
| D-0239-2018 | 01-09-2018 | Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-122-28. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Marksans Pharma Inc. / 23,088,900 tablets | Class II | Terminated |
| D-0240-2018 | 01-09-2018 | Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-123-27. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Marksans Pharma Inc. / 52,549,000 tablets | Class II | Terminated |
| D-0238-2018 | 01-09-2018 | Ibuprofen Tablets, USP 400 mg, 6 x 3500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-121-29. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Marksans Pharma Inc. / 21,584,100 tablets | Class II | Terminated |
| D-0235-2018 | 01-09-2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-117-30. Package NDCs: 25000-114-03; 25000-114-14; 25000-114-20; 25000-114-30; 25000-114-98; 25000-114-93; 25000-114-70; 25000-114-71; 25000-114-02; 25000-117-03; 25000-117-14; 25000-117-20; 25000-117-30; 25000-117-98; 25000-117-93; 25000-117-69; 25000-117-02 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Marksans Pharma Inc. / 2,853,500 Caplets | Class II | Terminated |
| D-0237-2018 | 01-09-2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-114-30. Package NDCs: 25000-114-03; 25000-114-14; 25000-114-20; 25000-114-30; 25000-114-98; 25000-114-93; 25000-114-70; 25000-114-71; 25000-114-02; 25000-117-03; 25000-117-14; 25000-117-20; 25000-117-30; 25000-117-98; 25000-117-93; 25000-117-69; 25000-117-02 | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Marksans Pharma Inc. / 205,088,000 tablets | Class II | Terminated |
| D-0236-2018 | 01-09-2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag shipper packs for further packaging, Rx only, Manufactured by: Marksans Pharma Ltd., Plot No. L-82, L-83, Verna Indl. Estate, Verna, Goa - 403 722, India, NDC 25000-136-20. | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies. | Marksans Pharma Inc. / 4,127,500 tablets | Class II | Terminated |
| D-0575-2018 | 01-05-2018 | MAGnesium 2 gm in NS 100 mL Magnesium SULfate (USP) 0.9% Sodium Chloride (USP) in 100 mL Sterile single dose bag, Rx only, Avella of Houston 9265 Katy Dr., Houston, TX ---NDC 42852-907-10 | Subpotent | Advanced Pharma Inc. / 25 bags | Class I | Terminated |
| D-0472-2018 | 01-04-2018 | Clopidogrel Tablets, USP 75 mg, 30-count bottles, Rx only, Packaged for: International Laboratories, LLC St. Petersburg, FL 33710, NDC 54458-888-16 | LABELING: LABEL MIX-UP. Simvastatin tablets, USP 10 mg were found in bottles labeled as Clopidogrel tablets, USP 75 mg. | International Laboratories, LLC / 218772 bottles | Class I | Terminated |
| D-0222-2018 | 01-03-2018 | Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, Manufactured for AvKARE, Inc. Pulaski, TN 38478, NDC 50268-512-15. | Failed Dissolution Specifications: Low out of specification results for dissolution during annual stability testing. | AVKARE Inc. / 237 cartons | Class II | Terminated |
| D-0339-2018 | 01-02-2018 | Ampicillin and Sulbactam for Injection 1.5 g vial, sterile Dry Powder for injection, 10 vials per carton, Distributed by AuroMedics Pharma LLC. 279 Princeton-Highstown Rd. E. Windsor, NJ 08520, NDC 55150-116-20 Package NDCs: 55150-116-20; 55150-117-20; 55150-178-99; 55150-179-99 | Presence of Particulate Matter: A confirmed customer report was received for the presence of visible particulate matter, confirmed as glass, within a single vial. | Aurobindo Pharma Ltd. / 53,040 vials | Class I | Terminated |
| D-0241-2018 | 12-28-2017 | Earth's Care Eczema Lotion (2% Colloidal Oatmeal) Skin Protectant with Aloe and Almond Oil, 8 fl. oz. (237 mL) HPDE bottle, Distributed by: Earth's Care Natural Products, Inc. Long Beach, California 90805, NDC 24286-1569-08, UPC 85730700307. | Microbial Contamination of Non-Sterile Products. | DLC Laboratories, Inc / 4,081 HDPE bottles | Class II | Terminated |
| D-0463-2018 | 12-27-2017 | Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0434-2018 | 12-27-2017 | Midazolam HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0458-2018 | 12-27-2017 | Ropivacaine HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0452-2018 | 12-27-2017 | Ketamine HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0465-2018 | 12-27-2017 | Meperidine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0440-2018 | 12-27-2017 | Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0436-2018 | 12-27-2017 | Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0433-2018 | 12-27-2017 | HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0449-2018 | 12-27-2017 | Midazolam HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0432-2018 | 12-27-2017 | Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0437-2018 | 12-27-2017 | Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0441-2018 | 12-27-2017 | Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0430-2018 | 12-27-2017 | Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0439-2018 | 12-27-2017 | Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0453-2018 | 12-27-2017 | Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0462-2018 | 12-27-2017 | Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0457-2018 | 12-27-2017 | HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0445-2018 | 12-27-2017 | Phenylephrine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0450-2018 | 12-27-2017 | Fentanyl Citrate Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0469-2018 | 12-27-2017 | Nicardipine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0446-2018 | 12-27-2017 | Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0456-2018 | 12-27-2017 | Atropine Sulfate Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0448-2018 | 12-27-2017 | Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0467-2018 | 12-27-2017 | Rocuronium Bromide in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0438-2018 | 12-27-2017 | Lidocaine HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0459-2018 | 12-27-2017 | Nicardipine HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0464-2018 | 12-27-2017 | Esmolol HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0451-2018 | 12-27-2017 | Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0461-2018 | 12-27-2017 | Neostigmine Methylsulfate Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0468-2018 | 12-27-2017 | Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0455-2018 | 12-27-2017 | Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0443-2018 | 12-27-2017 | Adenosine Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0435-2018 | 12-27-2017 | Midazolam HCl in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0447-2018 | 12-27-2017 | Labetalol HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0442-2018 | 12-27-2017 | Succinylcholine Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0429-2018 | 12-27-2017 | Bupivacaine HCl in 0.9% Sodium Chloride in all doses, all strengths, and packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / 297 bags | Class II | Terminated |
| D-0428-2018 | 12-27-2017 | HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0431-2018 | 12-27-2017 | Fentanyl Citrate and Bupivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0454-2018 | 12-27-2017 | Glycopyrrolate in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0444-2018 | 12-27-2017 | Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0466-2018 | 12-27-2017 | Methadone HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0460-2018 | 12-27-2017 | Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Pharmedium Services, LLC / Unknown | Class II | Terminated |
| D-0415-2018 | 12-22-2017 | Famciclovir Tablets, 500 mg, 30-count bottles, Rx Only, Manufactured For: Camber Pharmaceuticals. Inc. Piscataway, NJ 08854 By: HETERO, Hetero Labs Limited, Unit V, Polepally, Jadcherla, Mahaboob Nagar-509 301, India. NDC 31722-708-30 Package NDCs: 31722-706-30; 31722-706-60; 31722-706-01; 31722-706-05; 31722-706-10; 31722-707-30; 31722-707-60; 31722-707-01; 31722-707-05; 31722-707-10; 31722-708-30; 31722-708-60; 31722-708-01; 31722-708-05; 31722-708-10 | Temperature Abuse: Complaints of tablets being wet and stuck together with tablet coating peeled and disintegrated as a result of prolonged exposure to high temp during distribution. | Hetero Labs Limited Unit V / 8,436 bottles | Class II | Terminated |
| D-0223-2018 | 12-22-2017 | Simvastatin Tablets, USP, 40 mg, 1000-count bottle, Rx only, Manufactured for: Camber Pharmaceuticals, Inc., Piscataway, NJ 08854, Manufactured by: Hetero (trademark), Hetero Labs Limited, Jeedimetla, Hyderabad - 500 055, India, NDC 31722-513-10 Package NDCs: 31722-510-30; 31722-510-01; 31722-510-10; 31722-510-90; 31722-511-30; 31722-511-01; 31722-511-10; 31722-511-90; 31722-512-30; 31722-512-01; 31722-512-10; 31722-512-90; 31722-513-30; 31722-513-01; 31722-513-10; 31722-513-90; 31722-514-30; 31722-514-01; 31722-514-05; 31722-514-90 | Presence of foreign substance: metallic razor blade was found in one bottle. | Hetero Labs, Ltd. - Unit III / N/A | Class III | Terminated |
| D-0249-2018 | 12-21-2017 | Clobetasol Propionate Cream USP, 0.05% 60 g tube, Rx only Mfd. by: Taro Pharmaceutical Industries Ltd., Haifa Bay, Israel 2624761 Dist. by : Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532 UPC 351672125837 NDC 51672-1258-3 Package NDCs: 51672-1294-1; 51672-1294-2; 51672-1294-3; 51672-1258-1; 51672-1258-2; 51672-1258-6; 51672-1258-3; 51672-1259-1; 51672-1259-2; 51672-1259-6; 51672-1259-3; 3516721258 | Failed Content Uniformity Specifications | Taro Pharmaceuticals U.S.A., Inc. / 27,792 tubes | Class III | Terminated |
| D-0337-2018 | 12-20-2017 | Linezolid Injection 600 mg/300 mL (2 mg/mL), 300 mL Single-use, ready-to-use flexible plastic infusion bags in a foil laminate overwrap, Rx only, Mfd in India for: AuroMedics Pharma LLC, Dayton, NJ --- NDC 55150-242-51 Package NDCs: 55150-242-51 | Presence of Particulate Matter; white particulate matter identified as mold was found in one bag | AuroMedics Pharma LLC / 9,050 bags | Class I | Terminated |
| D-0232-2018 | 12-20-2017 | Dry to Normal Skin Starter Kit, Trousse debutante pour peau seche a normale. Kit includes: (Vegetable Cleanser (60 ml / 2 oz), Night Cream (15 g / 0.5 oz), Day Cream SPF15 {Octinoxate 7%, Avobenzone 2% and Oxybenzone 5%} (15 g / 0.5 oz), Eye Cream (6 g / 0.21 oz).Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics (USA) Inc. 99 Hudson, New York, NY, USA. UPC code 6 06354 61322 4 | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Odan Laboratories Ltd / 179 kits | Class II | Terminated |
| D-0231-2018 | 12-20-2017 | Day Cream SPF15 Cr¿me de jour FPS 15, { Avobenzone 2%, Octinoxate 7%, Oxybenzone 5%} 15 ml / 0.5 fl. oz jar. Made in Canada, Kamins Dermatologics Inc. Montreal, Quebec H9R 2Y6. Distributed by Kamins Dermatologics Montreal, Quebec H9R 2Y6 Made in Fabrique au Canada. UPC code 6 26354 10955 0 | Failed Stability Specifications:stability failure at 12 months, long term RT conditions. | Odan Laboratories Ltd / 21 jars | Class II | Terminated |
| D-0604-2018 | 12-20-2017 | DELFLEX Peritoneal Dialysis Solution, 2.5% Low Mg/Low Ca Single Bag, packaged in a) 3L (4 pack, NDC 49230-209-30), b) 2 L(6 pack NDC 49230-209-23), Rx only, Fresenius Medical Care NA, Waltham, MA 02451. Package NDCs: 49230-206-20; 49230-206-30; 49230-206-32; 49230-206-50; 49230-206-60; 49230-206-62; 49230-206-52; 49230-209-23; 49230-209-30; 49230-209-32; 49230-209-50; 49230-209-60; 49230-209-62; 49230-209-52; 49230-212-23; 49230-212-30; 49230-212-32; 49230-212-50; 49230-212-60; 49230-212-62; 49230-212-52 | Lack of Assurance of Sterility: Leakage of the peritoneal dialysis (PD) solution bag. | Fresenius Medical Care Renal Therapies Group, LLC / 3,734 cases | Class II | Terminated |
| D-0228-2018 | 12-19-2017 | Divalproex Sodium Delayed Release Tablets USP, 500 mg, 100-count bottle, RX Only, Manufactured by: Unichem Laboratories Ltd. Ind. Area, Meerut Road, Ghaziabad-201 003, India. Marketed By: Unichem Pharmaceuticals (USA), Inc. Hasbrouck Heights, NJ 07604. NDC 29300-140-01 Package NDCs: 29300-138-01; 29300-138-05; 29300-138-10; 29300-139-01; 29300-139-05; 29300-139-10; 29300-140-01; 29300-140-05; 29300-140-10 | Cross Contamination With Other Products: metronidazole powder was found in one bottle of Divalproex Sodium. | Unichem Pharmaceuticals Usa Inc / 96,876 Bottles of 30s | Class II | Terminated |
| D-0111-2018 | 12-18-2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 54 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-709-10 Package NDCs: 13811-709-10; 13811-706-10; 13811-707-10; 13811-708-10; 13811-710-10; 13811-710-30 | Subpotent Drug | Osmotica Pharmaceutical Corp / 9919 bottles | Class III | Terminated |
| D-0110-2018 | 12-18-2017 | Methylphenidate Hydrochloride Extended-release Tablets, USP 27 mg, 100-count bottles, Rx Only, Trigen Laboratories, LLC. Bridgewater, NJ 08807, NDC 13811-707-10 Package NDCs: 13811-709-10; 13811-706-10; 13811-707-10; 13811-708-10; 13811-710-10; 13811-710-30 | Subpotent Drug | Osmotica Pharmaceutical Corp / 10064 bottles | Class III | Terminated |
| D-0610-2018 | 12-15-2017 | Fosphenytoin Sodium Injection, USP 500 mg PE*/10 mL, Made in India. Distributed by: Amneal Biosciences, Bridgewater, NJ 08807, NDC 70121-1390-1 | Presence of particulate matter | Amneal Pharmaceuticals / 12,584 vials | Class II | Terminated |
| D-0211-2018 | 12-15-2017 | Gabapentin Oral Solution, 250 mg/5 mL (50 mg/mL) in a 470 mL amber-colored bottle, Rx Only. Manufactured by: Hi-Tech Pharmacal Co., Inc. Amityville, NY 11701. NDC: 50383-311-47 | CGMP Deviations: Inadvertent release of a drug product with unapproved active ingredient manufacturer. | Akorn Inc / 4,885 bottles | Class III | Terminated |
| D-0112-2018 | 12-15-2017 | 0.25% Acetic Acid Irrigation USP, 500 mL Plastic Irrigation Container (PIC), B. Braun Medical Inc. Irvine CA 92614-5895 USA, NDC 0264-2304-10 Package NDCs: 0264-2304-00; 0264-2304-10 | Presence of Particulate Matter: identified as polyethylene, which is consistent with the material used to manufacture the contain cap | B. Braun Medical Inc / 2,576 containers | Class II | Terminated |
| D-0217-2018 | 12-14-2017 | Shiseido Future Solution LX Luxurious Eye & Lip Collection contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0214-2018 | 12-14-2017 | bareMinerals Broad Spectrum SPF 50 Daily Prep Lotion (zinc oxide 23.8%, titanium dioxide 4.1%), 40 mL/1.35 fl. oz. bottle, Dist. by Bare Escentuals Beauty, Inc. SF, CA 94105 USA, NDC 98132-761-01 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / 248,661 bottle and /tubes | Class II | Terminated |
| D-0208-2018 | 12-14-2017 | Moexipril Hydrochloride and Hydrocholorothiazide Tablets USP, 7.5 mg/12.5 mg, 100-count bottle, Rx only, Distributed By: TEVA PHARMACEUTICALS USA, INC., North Wales, PA 19454, NDC 0093-5213-01. | Failed Impurities/Degradation Specifications: High out of specification test result for the Moexipril Diketopiperazine impurity was obtained during routine stability testing. | Teva Pharmaceuticals USA / 4,969 bottles | Class II | Terminated |
| D-0218-2018 | 12-14-2017 | Shiseido Future Solutions LX Triple Points Bonus contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, NDC 58411-256-60 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0215-2018 | 12-14-2017 | Shiseido Future Solution LX Universal Defense SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in a) 2mL, b) 15 mL and c) 50 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022. NDC 58411-256-60 | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0216-2018 | 12-14-2017 | Shiseido Future Solution LX Discovery Set contains SPF 50+ (octinoxate 4.9%, octocrylebe 3.0%, oxybenzone 1.0% and zinc oxide 15.4%), packaged in 15 mL tubes, Shiseido Americas Corporation Dist. New York, NY 10022, | GMP Deviations: manufacturing of API material did not meet GMP and quality requirements. | SHISEIDO AMERICA INC. / N/A | Class II | Terminated |
| D-0242-2018 | 12-14-2017 | SPIRIVA HandiHaler (tiotropium bromide inhalation powder) 18 mcg/capsule (90 capsules (unit dose blisters) per box, Rx Only, Made in Germany, Distributed by: Boehringer Ingelheim (BI) Pharmaceuticals, Inc., Ridgefield, CT 06877, NDC 0597-0075-47 Package NDCs: 0597-0075-41; 0597-0075-75; 0597-0075-47 | Failed Stability Specifications | Boehringer Ingelheim Pharmaceuticals, Inc. / 45,008 units/90 capsules each unit | Class II | Terminated |
| D-0545-2018 | 12-13-2017 | INFeD (Iron Dextran Injection USP) 100 mg elemental iron/2 ml (50 mg/mL), Rx Only, packaged in a) single dose vials, (NDC 52544-931-07), b) carton of 10 x 2 ml Single Dose Vials (NDC 52544-931-02) Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054, Manufactured by: Patheon Italia S.p.A. Ferentino, Italy 03013. | Failed Stability Specifications: Product stability testing results did not meet specifications for iron content. | ALLERGAN / 163,694 cartons | Class II | Terminated |
| D-0133-2018 | 12-12-2017 | Auryxia (ferric citrate) tablets, 210 mg , 200-count bottles, RX ONLY, Manufactured for and distributed by: Keryx Biopharmaceticals, Inc. One Marina Park Drive, 12th Floor, Boston, MA 02210 USA. NDC 59922-631-01 Package NDCs: 59922-631-01 | Presence of Foreign Substance: Reports have been received of damaged StripPax packets containing silica gel desiccant potentially allowing the silica gel granules to make contact with Auryxia tablets in the bottle. | Keryx Biopharmaceuticals, Inc. / 2,488 200-bottles | Class III | Terminated |
| D-0210-2018 | 12-12-2017 | Codeine-Guaifenesin Oral Solution 10-100 mg/5 mL Antitussive Expectorant ,16 fl. oz. , Manufactured For: Method Pharmaceuticals, LLC Arlington, TX 76006, NDC 58657-500-16 Package NDCs: 58657-500-04; 58657-500-16 | Microbial Contamination of Non-Sterile Products: potentially contamination with the bacteria Burkholderia cepacia | Woodfield Pharmaceutical, LLC / 15,707 bottles | Class II | Terminated |
| D-0471-2018 | 12-07-2017 | BodySlim Herbal Advanced technology & Strong formula capsules, 400 mg, 30-count bottle, Barcode: 9567153432481 | Marketed without an approved NDA/ANDA: FDA analysis found the product to contain undeclared sibutramine. | BotanicalNow / 5 bottles | Class I | Terminated |
| D-0156-2018 | 12-07-2017 | Ephedrine sulfate 5 mg/mL in 0.9% Sodium Chloride 10 mL in Single Dose Syringe, Total Volume 10 mL, Rx only, SCA Pharmaceuticals, 8821 Knoedl Ct. Little Rock, AR 72205, NDC 70004-0600-12 | Labeling: Incorrect or Missing Lot and/or Exp Date - product label was missing lot number and beyond use date. | SCA Pharmaceuticals / 1248 syringes | Class II | Terminated |
| D-0245-2018 | 12-07-2017 | Neutrogena Elevated 4-Holiday Trays (contains Neutrogena Deep Clean Purifying Whipped Foam Cleanser) Case Code: 00070501302866 | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. | Johnson & Johnson / | Class II | Terminated |
| D-0244-2018 | 12-07-2017 | Neutrogena deep clean purifying whipped foam cleanser, (Salicylic Acid 0.5%), aerosolized product in a can, NET WT. 5 OZ. (141 g) Distributed By: Johnson & Johnson Consumer Inc. Skillman, NJ 08558. UPC: 0 70501 10053 0 | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. | Johnson & Johnson / | Class II | Terminated |
| D-0243-2018 | 12-07-2017 | Neutrogena Acne Proofing whipped foam cleanser, (Salicylic Acid 2%), aerosolized product in a can, NET WT. 5 OZ (141 g) , Distributed by Johnson & Johnson Consumer Inc. Skillman, NJ 08558, UPC 0 70501 11131 4 | Defective Container: products showed leakage (bubbles, foaming) of propellant and product from the container valve cup area. | Johnson & Johnson / 67,260 units | Class II | Terminated |
| D-0153-2018 | 12-05-2017 | Enoxaparin Sodium, Injection 120 mg/0.8 mL, pre-filled, packaged in 10-count cartons, Rx Only, Winthrop US., a business of Sanofi-aventis, U.S. LLC Bridgewater, NJ 08807, NDC 0955-1012-10 Package NDCs: 0955-1003-01; 0955-1003-10; 0955-1004-01; 0955-1004-10; 0955-1006-01; 0955-1006-10; 0955-1008-01; 0955-1008-10; 0955-1010-01; 0955-1010-10; 0955-1016-01; 0955-1012-01; 0955-1012-10; 0955-1015-01; 0955-1015-10 | Labeling: Label Error on Declared Strength. A single syringe labeled as 150 mg/1.0 mL was found packaged in a blister labeled as 120 mg/mL | Sanofi-Aventis U.S. LLC / 11,474 cartons of 10 syringes per carton | Class III | Terminated |
| D-0340-2018 | 12-04-2017 | Pantoprazole Sodium for Injection, 40 mg per vial, single dose vial, Rx only, Manufactured in India for: AuroMedics Pharma LLC, 6 Wheeling ROad, Dayton, NJ 08810. NDC 55150-202-00 Package NDCs: 55150-202-00; 55150-202-10; 55150-202-25 | Presence of Particulate Matter: One vial from a lot of Pantoprazole Sodium for Injection (40 mg) contained a piece of glass | AuroMedics Pharma LLC / 66,100 vials | Class I | Terminated |
| D-0155-2018 | 12-04-2017 | Gabapentin Tablets, USP, 800 mg, 500-count, Rx only, Made in India, PONDRUGS/16 134193, Distributed by: Solco Healthcare US, LLC, Cranbury, NJ, 08512, USA. NDC 43547-0333-50 | Labeling: Label Mix-Up.some bottles labeled as Gabapentin 800 mg contain Gabapentin 600 mg | Solco Healtcare US LLC / N/A | Class II | Terminated |
| D-0154-2018 | 12-04-2017 | Viokace (pancrelipase) tablets, 20,880 USP units, 100-count bottle, Rx only, Distributed by; Allergan USA Inc., Irvine, CA 92612, Manufactured in Canada, NDC 58914-117-10 | Subpotent Drug: One lot of Viokace is being recalled since product stability testing results did not meet the specifications for enzyme profile. | ALLERGAN / 12,699 bottles | Class II | Terminated |
| D-0323-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Sufentanil Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown | Class II | Terminated |
| D-0320-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Fentanyl Citrate Base Solution dispensed between October 16, 2017 and November 17, 2017 Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown. | Class II | Terminated |
| D-0321-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Hydromorphone Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown | Class II | Terminated |
| D-0414-2018 | 11-30-2017 | Bull Capsules, 1800 mg/grain, 30 count per tin, Hongkong Jiuyuejiu Biology Technology CO., LTD, BYL Solutions, Inc. dba Nutra Labs, Inc., Palmetto, FL | Marketed without an Approved NDA/ANDA; product found to be tainted with sildenafil | BYL Solutions Inc. / 329 tins | Class III | Terminated |
| D-0322-2018 | 11-30-2017 | All sterile drug preparations remaining within expiry prepared from Morphine Sulfate PF Base Solution dispensed between October 16, 2017 and November 17, 2017, Compounded by Intrathecal Compounding Specialists, Scott, LA 70583. | Lack of sterility assurance. | Intrathecal Compounding Specialist, LLC / Unknown | Class II | Terminated |
| D-0247-2018 | 11-29-2017 | BLUE PEARL capsules, 500mg, 1-count packets, Distributed by Blue Pearl Long Beach, CA UPC 8 4704600978 5 | Marketed Without An Approved NDA/ANDA: FDA analysis found this product to contain undeclared sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making this an unapproved drug for which safety and efficacy have not been established and therefore, subject to recall. | Blue Fusion Natural / 300 pill cards | Class I | Terminated |
| D-0209-2018 | 11-29-2017 | Valsartan Tablets, USP, 160 mg, 90-count bottles, Rx Only, Manufactured by: Zhejiang Huahai Pharmaceutical Co., Ltd, Xunqiao, Linhai, Zhejiang 317024, China; Distributed by: Solco Healthcare US, LLC, Cranbury, NJ 08512, USA; NDC 43547-369-09. Package NDCs: 43547-367-03; 43547-367-09; 43547-367-50; 43547-367-11; 43547-368-03; 43547-368-09; 43547-368-50; 43547-368-11; 43547-369-03; 43547-369-09; 43547-369-50; 43547-369-11; 43547-370-03; 43547-370-09; 43547-370-50; 43547-370-11 | Failed Tablet/Capsule Specifications: confirmed customer complaint of thicker and heavier tablets in bottle. | Prinston Pharmaceutical Inc / 21,987 bottles | Class II | Terminated |
