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-0419-2018 | 01-29-2018 | Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx only, Mfd by: Dr. Reddy's Laboratories, Ltd., Srikakulam, INDIA --- NDC 55111-122-05 Package NDCs: 55111-121-30; 55111-121-60; 55111-121-90; 55111-121-05; 55111-121-10; 55111-122-30; 55111-122-60; 55111-122-90; 55111-122-05; 55111-122-10; 55111-123-30; 55111-123-60; 55111-123-90; 55111-123-05; 55111-123-10 | Failed Impurities/Degradations Specifications; out-of-specification results observed for Total Degradation Impurities during stability | Dr. Reddy's Laboratories, Inc. / a) 28,941 and b) 2,928 bottles | Class III | Terminated |
| D-0542-2018 | 01-29-2018 | Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3213-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3213-54. | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits | Teva Pharmaceuticals USA / 576, 760 (5 pouches/carton) | Class III | Terminated |
| D-0338-2018 | 01-29-2018 | Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes of 20 cups), Rx Only, Dist. By McKesson Packaging Services a business unit of McKesson Corporation 7101 Weddington Rd. Concord, NC 28027, NDC 63739-549-51 | Subpotent Drug: Out of specification for assay (stability testing) | Mckesson Packaging Services / 24120 cups | Class III | Terminated |
| D-0543-2018 | 01-29-2018 | Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-3214-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3214-54. | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits | Teva Pharmaceuticals USA / 554, 562 (5 pouches/carton) | Class III | Terminated |
| D-0540-2018 | 01-29-2018 | Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (NDC 0591-3198-72), Rx Only, Manufactured by: Actavis Laboratoies UT, Inc. Salt Lake City, UT 84108, Distributed by: Actavis Pharma, Inc. Parsippany, NJ 07054 USA. Individual pouch NDC 0591-3198-54. | Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the specification limits | Teva Pharmaceuticals USA / 1,118,046 (5 pouches/carton) | Class III | Terminated |
| D-0345-2018 | 01-26-2018 | Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-602-16. | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. | Primus Pharmaceuticals, Inc. / 135,277 bottles | Class I | Terminated |
| D-0347-2018 | 01-26-2018 | Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-606-16. | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. | Primus Pharmaceuticals, Inc. / 160,489 bottles | Class I | Terminated |
| D-0346-2018 | 01-26-2018 | Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-605-16. | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. | Primus Pharmaceuticals, Inc. / 4,006 bottles | Class I | Terminated |
| D-0344-2018 | 01-26-2018 | Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured for: Primus Pharmaceuticals, Inc., Scottsdale, AZ 85253; Manufactured by: Cornerstone Research and Development, Ogden, UT 84404, NDC 68040-601-16. | Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapproved drugs for which the safety and efficacy have not been established and, therefore, subject to recall. | Primus Pharmaceuticals, Inc. / 7,826 bottles | Class I | Terminated |
| D-0341-2018 | 01-25-2018 | PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC 55289-673-24; b) 30 tablets NDC 55289-673-30; c) 50 tablets NDC 55289-673-50; d) 60 tablets NDC 55289-673-60 | CGMP deviations. | PD-Rx Pharmaceuticals, Inc. / 7174 bottles | Class II | Terminated |
| D-0246-2018 | 01-24-2018 | Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use syringe. This is a Compounded Drug, Hospital & Office Use Only, Not for Resale. Fagron Sterile Services/JCB Laboratories, 7335 W. 33rd St. N., Wichita, KS 67205 | Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date. | JCB Laboratories LLC / 6,510 syriges | Class III | Terminated |
| D-0584-2018 | 01-24-2018 | Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g, Imported for: Shoppers Drug Mart Pharmaprix Toronto, M2J4W8, UPC 057800062653 | Superpotent drug: failed assay throughout the stick after 6 months stability. | Oxygen Development Llc / 12216 sticks | Class III | Terminated |
| D-0548-2018 | 01-22-2018 | Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Marketed by: Astellas Pharma US, Inc. Northbrook, IL 60062, NDC 0469-3211-10 | Labeling: Label Error on Declared Strength | Astellas Pharma US Inc / 63600 vials | Class II | Terminated |
| D-0248-2018 | 01-22-2018 | Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manufactured for Camber Pharmaceuticals, Inc., Piscataway, NJ, Manufactured by: Ascent Pharmaceuticals, Inc., Central Islip, NY --- NDC 31722-917-01 Package NDCs: 31722-484-01; 31722-484-05; 31722-485-01; 31722-485-05; 31722-917-01; 31722-917-05; 31722-486-01; 31722-486-05; 31722-918-01; 31722-918-05 | Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol | Ascent Pharmaceuticals, Inc. / 45,875 bottles | Class III | Terminated |
| D-0412-2018 | 01-22-2018 | Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by: AbbVie Inc., North Chicago, IL 60064, USA. NDC 0074-4456-51 Package NDCs: 0074-4456-51 | Defective container: presence of a hole in the liners of the caps covering the product bottle, introducing possibility of leakage. | AbbVie Inc. / 7,770 bottles | Class III | Terminated |
| D-0329-2018 | 01-19-2018 | Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp, Korea | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0335-2018 | 01-19-2018 | TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials, 10 vials + 10 amps x 4 mL, Manufactured by: Biomedica Foscama Industria, Ferentino, Italy | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0330-2018 | 01-19-2018 | Reiki Glutathione Whitening kits | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0250-2018 | 01-19-2018 | Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638-15); b) 30 g tubes (NDC 0713-0638-31); and c) 90 g tubes (NDC 0713-0638-18), Rx Only, Manufactured by: G&W Laboratories, Inc., South Plainfield, NJ 07080. Package NDCs: 0713-0638-15; 0713-0638-31; 0713-0638-18 | Discoloration: Product is supposed to be a white to off white homogenous cream and may have intermittent yellow discoloration. | G & W Laboratories, Inc. / 142,236 tubes | Class III | Terminated |
| D-0326-2018 | 01-19-2018 | Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0327-2018 | 01-19-2018 | Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0333-2018 | 01-19-2018 | Ling Zhi capsules | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0331-2018 | 01-19-2018 | TP Drug Laboratories Vitamin C ampules | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0595-2018 | 01-19-2018 | Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [NDC60687-179-11; UPC (01) 003 60687 179 11 7] per carton (NDC 60687-179-01), Rx Only, Distributed by: American Health Packaging, Columbus, Ohio 43217. Package NDCs: 60687-157-11; 60687-157-21; 60687-157-94; 60687-168-11; 60687-168-01; 60687-168-65; 60687-179-11; 60687-179-01; 60687-179-65; 60687-191-11; 60687-191-21; 60687-191-94; 60687-202-11; 60687-202-21; 60687-202-94; 60687-213-11; 60687-213-21; 60687-213-94 | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intended specifications. | AMERICAN HEALTH PACKAGING / 270 cartons | Class II | Terminated |
| D-0324-2018 | 01-19-2018 | Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg vials | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0325-2018 | 01-19-2018 | Relumins Vitamin C Solvent ampules | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0328-2018 | 01-19-2018 | Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettabile, Teofarma, s.r.l. | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0334-2018 | 01-19-2018 | Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg glass vials, Manufactured by: Shandong Luye Pharmaceutical Co, Ltd, Yantai, Shandong. PRC | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0332-2018 | 01-19-2018 | Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured in India | Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of different products sold individually or as part of multi-unit kits in accordance with Consent Decree of Permanent Injunction ordered by the United States District Court due to misbranding and unapproved new drugs pursuant to the FD&C Act. | Flawless Beauty LLC / N/A | Class II | Terminated |
| D-0342-2018 | 01-17-2018 | Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured for: Basic Drugs, Inc., Vandalia, Ohio 45377, UPC Code 3 07610 22020 1. | Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative contained only tablets of Naproxen Sodium 220 mg. | Magno Humphries Laboratories, Inc / 2,400 bottles | Class I | Terminated |
| D-0229-2018 | 01-16-2018 | DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Single Use Vial, Distributed by: Sun Pharmaceutical Industries , Inc. Cranbury, NJ 08512. Manufactured by: Sun Pharmaceutical Ind. Ltd. Halol-Baroda Highway. Halol-389 350, Gujarat, India. NDC 47335-049-40 Package NDCs: 47335-049-40; 47335-050-40 | Lack Of Assurance Of Sterility | Sun Pharmaceutical Industries, Inc. / 393 vials | Class II | Terminated |
| D-0426-2018 | 01-16-2018 | Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius Kabi, Lake Zurich, IL 60047, Made in India, NDC 63323-781-10 | Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related compound F at the 12 month stability test station. | Fresenius Kabi USA, LLC / 35,620 vials | Class III | Terminated |
| D-0234-2018 | 01-12-2018 | Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser carton, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-926-16. | Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle. | International Laboratories, Inc. / 13,403 cartons | Class II | Terminated |
| D-0233-2018 | 01-12-2018 | Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30 tablets for individual patient dispensing per pharmacy dispenser cartons, Rx only, Packaged for: International Laboratories, LLC. St. Petersburg, FL 33710, NDC 54458-927-16. | Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 mg tablets in the same bottle. | International Laboratories, Inc. / 9,052 cartons | Class II | Terminated |
| D-0574-2018 | 01-12-2018 | Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-Use flexible container, Rx Only, Manufactured for: AuroMedics Pharma LLC 6 Wheeling Drive, Dayton, NJ 08810 Manufactured for: Aurobindo Pharma Limited IDA, Pashamylaram - 502307, India ---- NDC 55150-243-46 Package NDCs: 55150-243-46; 55150-244-47; 55150-245-52 | Presence of Particulate Matter; contains visible particulate matter identified as mold. | AuroMedics Pharma LLC / 6,072 bags | Class I | Terminated |
| D-0600-2018 | 01-12-2018 | HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial, Sterile, Rx Only, Compounded by The Compounding Pharmacy of America, 6216 Highland Place Way, Ste. 101A Knoxville, TN 37919 Ph (855) 277-2488 Fax (888) 689-9892 | Non-Sterility | The Compounding Pharmacy of America / 5 vials | Class I | Terminated |
| D-0251-2018 | 01-11-2018 | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounded by: Premier Pharmacy Labs 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-160-35. | Labeling: Label Error on Declared Strength | Premier Pharmacy Labs Inc / 193 vials | Class II | Terminated |
| D-0688-2018 | 01-11-2018 | Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India | 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-0690-2018 | 01-11-2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India | 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-0691-2018 | 01-11-2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256 | 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-0693-2018 | 01-11-2018 | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India | 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-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-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-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-0686-2018 | 01-11-2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256 Package NDCs: 53943-291-15; 53943-291-12; 53943-291-14 | 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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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-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 |
