FDA Recall
Terminated
Historical recordClass II
Lidocaine 2.5% and Prilocaine 2.5% Cream, USP, packaged in a) 5 g tubes (NDC 0591-2070-72), b) 30 g tubes (NDC 0591-2070-30), Rx Only, Manufactured by: Teligent Pharma, Inc., Buena, NJ 08310, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, USA
by Teva Pharmaceuticals USA Inc
- Reason
- cGMP Deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Zonisamide Capsules, USP, 100 mg, packaged in: a) 100-count bottle (NDC 68462-130-01); b) 500-count bottle (NDC 68462-130-05), Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430
by Glenmark Pharmaceuticals Inc., USA
- Reason
- cGMP deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Zonisamide Capsules, USP, 50 mg, packaged in 100-count bottles, Rx only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-129-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- cGMP deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Completed
Historical recordClass II
Zonisamide Capsules USP, 25 mg, packaged in 100-count bottles, Rx Only, Manufactured by: Glenmark Pharmaceuticals, Inc., USA Monroe, NC 28110, Manufactured for: Glenmark Pharmaceuticals Inc., USA Mahwah, NJ 07430, NDC 68462-128-01
by Glenmark Pharmaceuticals Inc., USA
- Reason
- cGMP deviations
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Losartan Potassium Tab. USP 50mg, Pkg Size: 30, Mfg: Lupin Pharmaceuticals, Inc., Preferred Pharmaceuticals, Inc.
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits.
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass II
Suave 24-Hour Protection Aerosol Antiperspirant Fresh scent, Aluminum Chlorohydrate (19.1%), packaged in 6 oz. cans, Unilever, Dist. By Unilever, Trumbull, CT 06611 UPC 0 79400 78550 3
by Unilever United States Inc.
- Reason
- CGMP Deviation; manufactured at the same facility where other lots were found to be contaminated with benzene
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Ongoing
Historical recordClass I
Suave 24-Hour Protection Aerosol Antiperspirant Powder scent, Aluminum Chlorohydrate (19.1%), packaged in a) 4 oz. cans (UPC 0 79400 75150 8), and b) 6 oz. cans (UPC 0 79400 78490 2), Dist. By Unilever, Trumbull, CT 06611
by Unilever United States Inc.
- Reason
- Chemical contamination: presence of benzene
- Published
- May 4, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
artnaturals Hand Sanitizer
by VIRGIN SCENT INC
- Reason
- CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
by VIRGIN SCENT INC
- Reason
- Chemical Contamination: presence of benzene, acetaldehyde, and acetal.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
LL-37 2 mg/mL (5 mL) Injection, 5 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
BPC-157 2 mg/mL (5 mL) Injection, 5 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Pink Pussycat SENSUAL ENHANCEMENT capsule, 3000mg, 1-count blister card, Manufactured for: Pink Pussycat Products - Chatsworth, CA 91311, UPC 8 91875 00462 6.
by Pink Toyz
- Reason
- Marketed Without An Approved NDA/ANDA: FDA analysis found the product to contain undeclared sildenafil, an ingredient found in FDA approved products for the treatment of male sexual enhancement, making this an unapproved drug.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), 8 fl oz (236 ml) bottles, Dist. By artnaturals, Gardena, CA 90248, UPC: 8 16820 02820 5
by VIRGIN SCENT INC
- Reason
- CGMP Deviations: Other lots recalled because they were manufactured using common ingredients as the contaminated lot
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Sermorelin Acetate 1 mg/mL (6 mL) Injection, 6 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PT-141 (Bremelanotide Acetate) 10 mg/mL (2 mL) Injection, 2mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Melanotan II 1 mg/mL (10 mL) Injection, 10mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ipamorelin Acetate/Sermorelin Acetate (1 mg/1 mg)/mL (10 mL) Injection, 10 mL vials, Rx Only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
ARA-290 (Cibinetide Acetate) 6 mg/mL (4 mL) Injection, 4 mL vials, Rx only, Farmakeio 1736 N Greenville Ave Richardson, TX 75081 USA
by North American Custom Laboratories, LLC dba FarmaKeio Superior Custom Compounding
- Reason
- Lack of Assurance of Sterility: deviations from Current Good Manufacturing Practices (CGMP) that call into question the sterility of products intended to be sterile.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Rifampin for Injection, USP, 600 mg/vial, One Vial per carton, Rx only, Manufactured for: Mylan Institutional LLC, Morgantown, WV 26505 U.S.A., NDC 67457-445-60
by MYLAN PHARMACEUTICALS INC
- Reason
- Failed Impurities/Degradation Specifications: High out of specification results obtained for related compound during stability testing.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Diclofenac Sodium Topical Solution 1.5% w/w, Generic for Pennsaid, 150 ml bottle, Rx Only, Mfg: Sola Pharmaceutical, Preferred Pharmaceuticals, Inc., The Physicians Solutions, NDC 68788-7918-01
by Preferred Pharmaceuticals, Inc.
- Reason
- CGMP Deviations: all products within expiry are being recalled because the manufacturing firm, Teligent Pharma, Inc. is discontinuing its stability study program.
- Published
- April 27, 2022
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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