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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Showing 12,521–12,540 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass II

Guaifenesin Grape liquid 100 mg/5 mL, packaged in 4oz. bottles, co-packaged with a dosing cup in a carton and sold under the following: a) H.E.B. Mucus Relief, Children's Guaifenesin, Expectorant, Age 4+, Grape Flavor, Gluten Free, Alcohol Free, 4 FL OZ (118 mL) Bottle, Made for: H.E.B. San Antonio, TX 78204, NDC 37808-288-26; b) CVS, Children's Mucus Relief Chest Congestion, Guaifenesin, Expectorant, Alcohol free, Gluten free, 4 FL OZ (118 mL) Bottle, For Ages 4 to 12 Years, Grape Flavor Liquid, Dosage Cup Included, Distributed by CVS Pharmacy Inc, One CVS Drive, Woonsocket, RI, 02895, NDC 59779-288-26.

by Perrigo Company PLC

Reason
Defective Delivery System: Firm recalled Guaifenesin liquid and Guaifenesin DM liquid due incorrect dose markings on the dosing cups.
Recall initiated
January 8, 2016
Reported by FDA
February 3, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Bromfenac Ophthalmic Solution 0.09%, a) 2.5 mL bottles (NDC 0378-7110-35) and b) 5 mL bottles (NDC 00378-7109-35), Rx only, Mylan Pharmaceuticals, Inc., Morgantown, WV 26505

by Mayne Pharma Usa

Reason
Lack of Assurance of Sterility: Failed preservative effectiveness test
Recall initiated
January 5, 2016
Reported by FDA
January 27, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Bevacizumab 2.5 mg/0.1 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal injection, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Recall initiated
November 4, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Bevacizumab 2 mg/0.08 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Recall initiated
November 4, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Bevacizumab 1.25 mg/0.05 mL filled to 0.06 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal, Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Recall initiated
November 4, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Bevacizumab 1.25 mg/0.05 mL in 3/10 mL 31 G 5/16" Syringe for intravitreal Rx -- Pine Pharmaceuticals, 100 Colvin Woods Pkwy Suite 300, Tonawanda, NY 14150.

by Pine Pharmaceuticals, LLC

Reason
Presence of particulate matter: Presence of silicone oil microdroplets in bevacizumab syringes for intravitreal use.
Recall initiated
November 4, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

Energique, Homeopathic Remedy, First Aid Pain & Trauma Relief, 1 fl oz (30 ml) bottles, NDC 44911-0135-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, First Aid Pain & Trauma Relief, Topical Homeopathic Spray, NDC 50845-0216-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, First Aid Pain & Trauma Relief, homeopathic spray, UPC 8 18692 00895 8, NDC 43846-0045-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA

by Grato Holdings, Inc.

Reason
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recall initiated
December 22, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and to Guatemala and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

Energique, Homeopathic Remedy, Headache Pain & Sinus Pressure Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0134-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Headache Pain & Sinus Pressure Relief, Topical Homeopathic Spray, NDC 50845-0217-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Headache Pain & Sinus Pressure Relief, homeopathic spray, UPC 8 18692 00885 9, NDC 43846-0041-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA

by Grato Holdings, Inc.

Reason
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recall initiated
December 22, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and to Guatemala and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

Energique, Homeopathic Remedy, Shingles Pain & Ulceration Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0137-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Shingles Pain & Ulceration Relief Topical Homeopathic Spray, NDC 50845-0215-1, Dist By Liddell Laboratories, Inc., Woodbine, IA 51579; and peaceful mountain, Shingles Pain & Ulceration Relief, homeopathic spray, UPC 8 18692 00875 0, NDC 43845-0044-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA

by Grato Holdings, Inc.

Reason
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recall initiated
December 22, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and to Guatemala and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

Energique, Homeopathic Remedy, Joint Pain & Stiffness Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0133-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Joint Pain & Stiffness Relief, Topical Homeopathic Spray, NDC 50845-0218-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Joint Pain & Stiffness Relief, homeopathic spray, UPC 8 18692 00890 3, NDC 43846-0042-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA

by Grato Holdings, Inc.

Reason
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recall initiated
December 22, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and to Guatemala and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

Energique, Homeopathic Remedy, Muscle/Tendon Pain & Stress Relief, Topical Spray, 1 fl oz (30 ml) bottles, NDC 44911-0132-1, Dist. by Energique, Inc. Woodbine, IA 51579; ALSO LABELED AS --- Liddell Laboratories, Muscle/Tendon Pain & Stress Relief, Topical Homeopathic Spray, NDC 50845-0219-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, Muscle/Tendon Pain & Stress Relief, homeopathic spray, UPC 8 18692 00870 5, NDC 43846-0043, Dist. by Peaceful Mountain, Inc. Woodbine, IA

by Grato Holdings, Inc.

Reason
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recall initiated
December 22, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and to Guatemala and Canada.

View recall →

Drug Recall Terminated Historical recordClass II

Energique, Homeopathic Remedy, Skin Irritant & Healing Support, Topical Spray, 1 fl oz bottle, NDC 44911-0136-1, Dist. by Energique, Inc., Woodbine, IA; ALSO LABELED AS --- Liddell Laboratories, Skin Irritant & Healing Support, Topical Homeopathic Spray, NDC 50845-0214-1, Dist By Liddell Laboratories, Inc., Woodbine, IA; and peaceful mountain, skin irritant & healing support, homeopathic spray, UPC 8 18692 00880 4, NDC 43846-0046-1, Dist. by Peaceful Mountain, Inc. Woodbine, IA

by Grato Holdings, Inc.

Reason
Microbial Contamination of Non Sterile Products; testing revealed out of specification results for total aerobic microbiological count
Recall initiated
December 22, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and to Guatemala and Canada.

View recall →

Drug Recall Terminated Historical recordClass III

Phentermine Hydrochloride Capsules, USP, 15 mg, packaged in a) 7-count (NDC 55289-791-07), b) 14-count (NDC 55289-791-14), c) 28-count (NDC 55289-791-28), d) 30-count (NDC 55289-791-30), and e) 60-count (NDC 55289-791-60) bottles, Packaged by PD-RX Pharmaceuticals, INC Oklahoma City, OK 73127, MFG: KVK-TECH, INC Newtown, PA 18840.

by PD-Rx Pharmaceuticals, Inc.

Reason
Failed impurities/Degradation specifications: out of specification results for individual unknown and total impurity at the 12th month room temperature stability test station
Recall initiated
July 21, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen USP powder, packaged in (a) 25gm (4 oz container), (b) 100gm (16 oz container), (c) 500 gm (70 oz container), and (d) 1000 gm (120 oz container, Rx only, 801 W New Orleans St. Broken Arrow, OK 74011. NDC: (a) 52372-0909-25; (b) 52372-0909-01; (c) 52372-0909-50; (d) 52372-0909-10.

by Freedom Pharmaceuticals Inc

Reason
Presence of Foreign Substance
Recall initiated
November 9, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Sulfamethoxazole and Trimethoprim Tablets, USP, 800 mg/160 mg DOUBLE STRENGTH, 100-count bottle, Rx only, Mfg. by: Mutual Pharmaceutical Company, Inc., Philadelphia, PA 19124, Dist. by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ 08512, NDC 53489-0146-01

by Mutual Pharmaceutical Company, Inc.

Reason
Presence of foreign substance -This recall has been intiated due to the presence of a polyethylene piece on the finished product.
Recall initiated
October 9, 2015
Reported by FDA
January 27, 2016
Distribution
MS

View recall →

Drug Recall Terminated Historical recordClass III

Lindane Lotion, USP 1%, For External use Only, Rx Only, 2 fl oz (60 mL) bottle, MGP, NDC 60432-833-60

by Morton Grove Pharmaceuticals, Inc.

Reason
Super-Potent Drug: Out of Specification Assay test results were reported for stability samples.
Recall initiated
December 15, 2015
Reported by FDA
January 27, 2016
Distribution
Nationwide and Puerto Rico

View recall →

Drug Recall Terminated Historical recordClass II

IT Custom Compound (BC) Baclofen 2000 mcg/ml, Clonidine 2 mcg/ml 40 ml PF syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614

by Amerita Specialty Infusion Services

Reason
Lack of Assurance of Sterility
Recall initiated
December 24, 2015
Reported by FDA
January 27, 2016
Distribution
AZ only. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass II

Baclofen 1 mg/ml in 40 ml NS syringe, FOR INTRATHECAL USE ONLY, Rx Only, Compounded by Amerita, Inc., Prescott, AZ 86305-1614

by Amerita Specialty Infusion Services

Reason
Lack of Assurance of Sterility
Recall initiated
December 24, 2015
Reported by FDA
January 27, 2016
Distribution
AZ only. No foreign distribution.

View recall →

Drug Recall Terminated Historical recordClass III

Life-Line DOCUSATE CALCIUM Sodium Free STOOL SOFTENER 240 mg each, 100 softgels per bottle. UPC 0-79854-95005-2 Manufactured and Distributed by: NATIONAL VITAMIN COMPANY Casa Grande, AZ 85122. NDC 54629-0640-01

by National Vitamin Co Inc

Reason
Labeling: Label mix-up. Docusate Sodium 100mg Softgels were mislabeled as Docusate Calcium 240mg.
Recall initiated
December 18, 2015
Reported by FDA
January 20, 2016
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Domperidone BP, Active Pharmaceutical Ingredient for Prescription Compounding, packaged in a) 5 gm (NDC: 52372-0898-01), b) 25 gm (NDC: 52372-0898-02), c) 100 gm (NDC: 52372-0898-03), and d) 500 gm (NDC: 52372-0898-04), Cas No. 57808-66-9, Rx only, FREEDOM, 801 W. New Orleans St., Broken Arrow, OK 74011.

by Freedom Pharmaceuticals Inc

Reason
Penicillin Cross Contamination: Potential for products to be cross-contaminated with penicillin.
Recall initiated
March 10, 2015
Reported by FDA
January 20, 2016
Distribution
Nationwide

View recall →

Data last updated:

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.