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Product Description Quantity Distribution Reason for Recall Recalling Firm Report Date Initiation Date Days To Report Country State City Voluntary or Mandated Classification Code Info
Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Compounded Guardian Pharmacy Services, 7920 Elmbrook Dr. Ste. 108C Dallas TX 75247 2000 100-ml vials Texas Lack of sterility assurance. Guardian Pharmacy Services 20180815 20180517 90 United States TX Dallas Voluntary: Firm Initiated Class II Lots: 58409:42, Use By: 05/21/2018; 58899:42, Use By: 07/04/2018; 59215:42 Use By: 08/01/2018
Gaia Kratom (mitragyna speciosa) powder, Red Kapuas Hulu , 1oz, 250g, 1kg packages, Gaia Ethnobotanical.com unknown Nationwide. Microbal Contamination of Non-Sterile Product; FDA analysis found salmonella contamination Gaia Ethnobotanical LLC 20180718 20180620 28 United States NV Henderson Voluntary: Firm Initiated Class I Lot # 0102031800
Capecitabine 500 mg Tablet NDC 00378-2512-78 28 days supply and 21 days supply Unknown MS, LA, AR, IL, FL Lack of Processing Controls. Kroger Specialty Pharmacy, Inc. 20180516 20180403 43 United States MS Vicksburg Voluntary: Firm Initiated Class II All lots remaining within expiry dispensed 12/01/2017 through 02/12/2018
STREE OVERLORD capsules, 3800 mg, 4-count bottle, labeling is in foreign language unknown NY and NJ through six retail stores named "Asian Food Markets" Marked Without An Approved NDA/ANDA: FDA analysis found these products to contain sildenafil, an FDA approved drug for the treatment of erectile dysfunction, making these products unapproved drugs for which safety and efficacy have not been establish and therefore, subject to recall. A&H Focal Inc. 20180207 20170307 337 United States NY Staten Island Voluntary: Firm Initiated Class II All Lots
Estrone Micronized, USP, Bulk, Rx only, For Prescription Compounding, Manufactured by Qinhuangdao Zizhu Pharmaceutical Co., Ltd., Qinhuangdao 066004, China (NDC 44132-003-04) (NDC 44132-003-02)(NDC 44132-003-06) Product distributed to NY, TX, SC, CO, MN and NJ cGMP Deviations; lack of quality assurance. Qinhuangdao Zizhu Pharmaceutical, Co. 20170419 20170324 26 China Qinhuangdao Voluntary: Firm Initiated Class II Batch 82801505001 to 82801606001, exp 5/4/2017 through 5/19/2018
Renovo Patch (Capsaicin, 0.0375%, Menthol, USP 5.00%), 3-count patches per carton, Rx only, Distributed By: TMIG Inc, Marietta , GA 30062, Manufactured By: Pocono Coated Products LLC., Cherryville, NC 28021 NDC: 69176-025-03 unknown Nationwide Marketed Without An Approved NDA/ANDA: product is an unapproved drug and additionally 3 lots were found to be subpotent. TMIG Inc 20160525 20160323 63 United States GA Marietta Voluntary: Firm Initiated Class II All lots
APEXXX tablets, 300 mg, packaged in 1-count blister cards, Distributed Exclusively by: Nuway Distributors, LLC, Orlando, FL USA; UPC 7 05105 96361 7. 100,000 blister cards All product is sold to Ace Distributors, LLC in Orlando, FL, a retail store, who sells directly to owners of gas stations, convenience stores, and smoke shops where it can be further distributed nationwide. Marketed Without An Approved NDA/ANDA: tainted product marketed as a dietary supplement. Product found to be tainted with sildenafil, an FDA approved drug for the treatment of male erectile dysfunction, making this an unapproved drug. Nuway Distributors, LLC 20160224 20151223 63 United States FL Orlando Voluntary: Firm Initiated Class I All lots
RANITIDINE SYRUP (RANITIDINE ORAL SOLUTION, USP) 15 mg/mL (75 mg/5 mL), 473 mL (16 fl oz), Rx only. Manufactured for: QUALITEST PHARMACEUTICALS, HUNTSVILLE, AL 35811, NDC: 0603-9418-58. 61,146 Bottles U.S. Nationwide Failed Stability Specifications: Out of Specification results obtained for preservative butylparaben. Vintage Pharmaceuticals LLC, DBA Qualitest Pharmaceuticals 20151111 20151021 21 United States AL Huntsville Voluntary: Firm Initiated Class III Lot #: L088L13A, Expiry: 12/15; Lot #: L023F14A, Expiry: 5/16; Lot#: L024F14A, Expiry: 5/16.
Famotidine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 4716 grams Nationwide to compounding pharmacies and research organizations. Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Attix Pharmaceuticals 20150429 20141114 166 Canada Toronto Voluntary: Firm Initiated Class II All lots repackaged and distributed between 01/05/12 to 02/12/15
Doxycycline HCI active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 38900 grams Nationwide to compounding pharmacies and research organizations. Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Attix Pharmaceuticals 20150429 20141114 166 Canada Toronto Voluntary: Firm Initiated Class II All lots repackaged and distributed between 01/05/12 to 02/12/15
Seratonin HCl active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 1454 grams Nationwide to compounding pharmacies and research organizations. Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Attix Pharmaceuticals 20150429 20141114 166 Canada Toronto Voluntary: Firm Initiated Class II All lots repackaged and distributed between 01/05/12 to 02/12/15
Loratadine active pharmaceutical ingredient packaged in varying grams or kg in bags or drums, Attix Pharmaceuticals, 184 Front Street East, Unit 801, Toronto, Ontario M5A 4N3, Canada 50 grams Nationwide to compounding pharmacies and research organizations. Penicillin Cross Contamination: All lots of all products repackaged and distributed between 01/05/12 and 02/12/15 are being recalled because they were repackaged in a facility with penicillin products without adequate separation which could introduce the potential for cross contamination with penicillin. Attix Pharmaceuticals 20150429 20141114 166 Canada Toronto Voluntary: Firm Initiated Class II All lots repackaged and distributed between 01/05/12 to 02/12/15
Diclofenac Sodium and Misoprostol Delayed-Release Tablets, 75 mg/0.2 mg, 60-count bottle, Rx only, Manufactured by: Watson Laboratories, Inc., Corona, CA 92880, NDC 0591-0398-60, UPC 3 05910 39860 6. 36,538 bottles Nationwide and Puerto Rico Failed Tablet/Capsule Specifications: Recall due to complaints of split or broken tablets. Actavis Laboratories, FL, Inc. 20141008 20140424 167 United States FL Davie Voluntary: Firm Initiated Class II Lot #: 605956A, 605958A, Exp. 9/30/2014; 644678M, Exp. 10/31/2014; 661841A, Exp. 11/30/2014; 717469A, Exp 2/28/2015
Warfarin Sodium Tablets, USP Crystalline, 2 mg, 100 and 1000 Tablet Bottles, Rx Only. Mfd. by: Taro Pharmaceutical Industries, Ltd., Haifa Bay, Israel 26110. Dist. by: Taro Pharmaceuticals U.S.A., Inc., Hawthorne, NY 10532. 100 Tablet Bottle NDC: 51672-4028-1, 1000 Tablet Bottle NDC: 51672-4028-3. 1396 Bottles United States including: OH, HI, NH, MS, IL, TX, CA. Failed Content Uniformity Specifications. Taro Pharmaceuticals U.S.A., Inc. 20140924 20140825 30 United States NY Hawthorne Voluntary: Firm Initiated Class III Lot #: 149400, Expiry: January 2016; Lot #: 149649, Expiry: January 2016.
Black Ant, 4600 mg x 4. Product is packaged in a small green box with gold lettering on the front, the back side of the box contains mostly foreign character. Within the box there are four (4) capsules individually wrapped in black and red plastic with white lettering. UPC 4026666142546 (product numbers may possibly vary for same product identification and same product packaging). 3 boxes distributed domestically & 4 boxes distributed internationally to consumers. Domestic distribution currently under Investigation; International distribution includes, but may not be limited to the following countries : Mexico, France, Brazil, Belgium, Denmark, Switzerland, Spain, Canada, Italy, Japan, Ireland, Venezuela, Oman. Marketed without an Approved NDA/ANDA: Laboratory analysis conducted by the FDA has determined the Vicerex product contains undeclared tadalafil and the Black Ant product contains undeclared sildenafil. Tadalafil and sildenafil are FDA-Approved drugs used to treat male erectile dysfunction (ED), making the Vicerex and the Black Ant products unapproved new drugs. American Lifestyle.Com 20140416 20130430 351 United States NY Pittsford Voluntary: Firm Initiated Class I All lots, UPC 4026666142546.
LEVOTHYROXINE SODIUM, Tablet, 125 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074706890. 90 Tablets Repacked drugs were distributed in Arizona, California, Oregon, and Washington. Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 125 mcg may have potentially been mislabeled as the following drug: MAGNESIUM CHLORIDE DR, Tablet, 64 mg, NDC 00904791152, Pedigree: AD70615_1, EXP: 2/28/2014. Aidapak Services, LLC 20140129 20130702 211 United States WA Vancouver Voluntary: Firm Initiated Class II LEVOTHYROXINE SODIUM, Tablet, 125 mcg has the following codes: Pedigree: AD70633_4, EXP: 5/23/2014.
LEVOTHYROXINE SODIUM, Tablet, 175 mcg, Rx only, Distributed by: AidaPak Service, LLC, NDC 00074707090. 90 Tablets Repacked drugs were distributed in Arizona, California, Oregon, and Washington. Labeling: Label Mixup: LEVOTHYROXINE SODIUM, Tablet, 175 mcg may have potentially been mislabeled as the following drug: CINACALCET HCL, Tablet, 60 mg, NDC 55513007430, Pedigree: W003742, EXP: 6/26/2014. Aidapak Services, LLC 20140129 20130702 211 United States WA Vancouver Voluntary: Firm Initiated Class II LEVOTHYROXINE SODIUM, Tablet, 175 mcg has the following codes: Pedigree: W003743, EXP: 6/26/2014.
Betamethasone NA Phosphate (PF) 6mg/ml 10ml, Main Street Compounding Pharmacy, 126 East Main Street, Newbern, TN 38059, 888-658-6200 2 units nationwide, specifically: AK, AL, AZ, CA, CO, CT, DC, FL, GA, HI, IL, IN, KS, KY, LA, MA, MD, MN, MO, MS, NC, NE, NH, NJ, NM, NV, NY, OH, OK, OR, PA, SC, TN, TX, UT, VA, WA, WI, and WV The firm received seven reports of adverse reactions in the form of skin abscesses potentially linked to compounded preservative-free methylprednisolone 80mg/ml 10 ml vials. Main Street Family Pharmacy, LLC 20131211 20130528 197 United States TN Newbern Voluntary: Firm Initiated Class II all codes distributed prior to and including 05/23/2013
Diazepam Injection, USP, 5 mg/mL, 10 mL, Multiple-dose Sterile Non-pyrogenic, Fliptop Vial, C-IV, Rx Only, Hospira, Inc., Lake Forest, IL 60045, USA, NDC 0409-3213-12 72,300 vials Nationwide and Puerto Rico Lack of assurance of sterility: ineffective crimp on fliptop vials that may result in leaking at the neck of the vials. Hospira Inc. 20130904 20130816 19 United States IL Lake Forest Voluntary: Firm Initiated Class II Lot: 23-505-EV, Exp. 11/14
Methylprednisolone Acetate injectable Balanced Solutions, Compounding Pharmacy a division of Axium Healthcare Pharmacy, Inc., Lake Mary, FL 32746 326 vials (10 mL each) CO, GA, MI, and Puerto Rico Lack of Assurance of Sterility:All sterile products compounded, repackaged, and distributed by this compounding pharmacy due to lack of sterility assurance and concerns associated with the quality control processes. Axium Healthcare Pharmacy dba Balanced Solutions Compounding 20130501 20130417 14 United States FL Lake Mary Voluntary: Firm Initiated Class II All Lots