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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 7,421–7,440 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

AZACITIDINE 125 MG / 5 ML SUB-Q SYRINGE; AZACITIDINE 75 MG (3 ML) SYRINGE, AZACITIDINE 135 MG / 5.4 ML SUB-Q SYRINGE, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass II

AVASTIN 630 MG / 100 ML 0.9% NACL IVPB; AVASTIN 2.5 mg/ 0.1ML Syringe; AVASTIN 587.5 MG/100 ML 0.9% NACL IVPB; AVASTIN 350 MG/100 ML 0.9% NACL IVPB; AVASTIN 325 MG / 100 ML 0.9% NACL IVPB; AVASTIN 3.75 mg/ 0.15 ML Syringe; AVASTIN 416 MG / 100 ML 0.9% NACL IVPB; AVASTIN 360 MG/100 ML 0.9% NACL IVPB; AVASTIN 250 MG / 100 ML 0.9% NACL IVPB; AVASTIN 693.125 MG/100 ML 0.9% NACL IVPB; AVASTIN 1020 MG/100 ML NS IVPB; AVASTIN 811.875 MG/100 ML 0.9% NACL IVPB; AVASTIN 1006.25 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass II

ATEZOLIZUMAB 1200 MG / 250 ML 0.9% NACL, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass II

ALIMTA 785 mg QS 100 ml 0.9% NACL IVPB; ALIMTA 1000 mg QS 100 ml 0.9% NACL IVPB; Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass II

ADO-TRASTUZUMAB 210 MG/250 ml NS; ADO-TRASTUZUMAB E 213 MG / 250 ML NS; ADO-TRASTUZUMAB 242 MG/250 ml NS; ADO-TRASTUZUMAB EMT 168 mg / 250 ml NS; ADO-TRASTUZUMAB E 160 MG / 250 ML NS ADO-TRASTUZUMAB 150 mg / 250 ml NS; ADO-TRASTUZUMAB EMT 301 mg / 250 ml NS; ADO-TRASTUZUMAB EMTANSINE 230mg/250ml NS IV Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass II

Adcetris 96 MG/100 ML NS IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass II

Abraxane 170 MG / 34 ML IVPB; Abraxane 200 MG / 40 ML IVPB; Abraxane 180 MG / 36 ML IVPB, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass II

Oxytocin 60 units/1000 mL Lactated Ringers Intravenous Solution, Rx Only, Infusion Options, Inc. 5924 13the Ave, Brooklyn, NY 11219-4934, 718-283-7233

by Infusion Options, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
June 12, 2019
Reported by FDA
August 21, 2019
Distribution
NY only

View recall →

Drug Recall Terminated Historical recordClass III

Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tubes, Rx only, Manufactured by: Glenmark Pharmaceuticals Ltd. Village: Kishanpura, Baddi Nalagarth Road, District: Solan, Himachal Pradesh-173205, India. Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-298-17

by Glenmark Pharmaceuticals Inc., USA

Reason
Temperature Abuse: Complaints received of liquidy texture.
Recall initiated
August 7, 2019
Reported by FDA
August 21, 2019
Distribution
Nationwide with the United States

View recall →

Drug Recall Terminated Historical recordClass II

CRYO-273 Cold Pain Relieving Gel 128 FL. OZ. Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01550 2

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Wonder Freeze Pain Releiving Gel with ILEX, Menthol 5%, packaged in a) 3 OZ /85 g (UPC 0 99528 35903 5); b) 4 OZ / 113 g (UPC 0 99528 31504 8); c) 16 OZ / 454 g (UPC 0 99528 31516 1); Manufactured For: Wonder Laboratories, 115 S.C.T. Ct., White House TN. 37188.

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Kool Comfort Cooling Pain Relief, 5% Menthol, Packaged in a) 3 OZ./85 g (UPC 0 52301 35903 5); b) 4 OZ/ 113 g (UPC 0 52301 36504 3); c) 32 OZ/ 907 g (UPC 0 52301 36532 6); d) 16 OZ/ 454 g (UPC 0 52301 36516 6); e) 128 OZ/ 3629 g (UPC 0 52301 36512 8) Manufactured for: Dee Cee Laboratories, Inc. 304 Dee Cee Rd., White House, TN 37188.

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Cool Hot Ice Analgesic Gel, 8 oz (227 g) Distributed by: Unipack Inc. Pittsburg, PA 15239, USA. UPC 7 51393 00608 6

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CRYO-273 Cold Pain Relieving Gel Roll-On 3 FL. OZ. (89 mL) Distributed By: CRYO-273.com Tampa, FL 33629. UPC 8 15290 01529 6

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

CVS Health Glycerin Suppositories, 100- count box, Distributed by:Distributed by: CVS Pharmacy, Inc. One CVS Drive Woonsocket, RI 02895. UPC 0 50428 42738 5

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Soothe&Cool Protect Moisture Guard Skin Protectant, 3.5 oz. (99 g), tube, Manufactured for Medline industries, Inc., Mundelein, IL 60060. NDC 53329-303-22

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-04, UPC 3 11917 18247 6

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Hydrocortisone Cream, Hydrocortisone 1% / Anti-Itch Cream, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0638-03, UPC 3 11917 18245 2 .

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 2 OZ (56 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-04, UPC 3 11917 17934 6

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Hydrocortisone Cream With Aloe, Hydrocortisone 1% / Anti-Itch Cream with Aloe, 1 OZ (28 g) tube. Distributed By: Walgreen Co. 200 Wilmot Rd., Deerfield, IL 60015. NDC #0363-0620-03, UPC 3 11917 17935 3

by US Pharmaceuticals Inc.

Reason
CGMP Deviations: Out of Specification results for either total microbial count or total organic carbon in the purified water utilized in the manufacturing process.
Recall initiated
July 11, 2019
Reported by FDA
August 21, 2019
Distribution
Distributed Nationwide in the USA

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.