Drug and pharmaceutical recalls
17624 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-04-06FDA-DrugDr. Reddy's Laboratories, Inc.Class IIIAtorvstatin Calcium Tablets, USP 80 mg*, 90 Tablets, Rx Only, Mrd. By: Dr. Reddy's Laboratories Limited, Srikakulam - 532 409, INDIA, NDC 55111-124-90
Failed Impurities/Degradation Specifications: Out of Specification results for related substance.
- 2022-03-30FDA-DrugFresenius Kabi USA, LLCClass ISodium Acetate Injection, USP, 400 mEq / 100 mL (4 mEq / mL), packaged in 2 trays of 20 vials per shipper (NDC 63323-032-00), each vial: 100 mL fill in a 100 mL vial (NDC 63323-032-04), Rx Only, Fresenius Kabi, Lake Zurich, IL 60047
Presence of particulate matter: particulates composed of carbon and oxygen with varying amounts of iron and trace amounts of sodium, silicon, chromium, aluminum and cellulose.
- 2022-03-30FDA-DrugTennessee Technical Coatings, Corp.Class IIHAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufactured under the same conditions as the product lot found to contain methanol.
- 2022-03-30FDA-DrugTennessee Technical Coatings, Corp.Class IHAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/3.785 Liters Tennessee Technical Coatings Corporation, 1421 Higgs Road (P.O. Box 1698) Lewisburg, TX 37091, NDC 76921-000-01
Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, to contain methanol.
- 2022-03-30FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISincalide Lyophilized powder for reconstitution Each ML contains: Mannitol 170mg, Arginine 30mg, Lysine 15mg, Potassium Phosphate 9mg, Methionine 4mg, Edetate Disodium Dihydrate 2mg, Polysorbate mcg, Water for Injection, Multiple Dose Injection 5 mcg Vial, Rx Only, Olympia Compounding Pharmacy Compounded by: Olympia Pharmacy Conroy Rd., Ste. 155, Orlando, FL 32835, NDC 73198-0082-00 Revised Label: Sincalide Lyophilized powder for reconstitution, 5mcg per multi dose vial, Each ML contains: 16.
Super Potent and Failed Reconstitution Time
- 2022-03-30FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIIHydroxocobalamin B12 1mg/mL, Multi-Dose 30 mL vial, Each ML contains: 0.82% Sodium Chloride USP, 0.9% Benzyl Alcohol NF, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals Conroy Rd., Ste. 155, Orlando, FL 32835 NDC 73198-0080-30
Sub Potent
- 2022-03-30FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIISB-4, Papaverine 30mg/mL, Phentolamine 3mg/mL, Alprostadil 40mcg/mL, packaged in a) 5 mL Multi-dose vial NDC 73198-0023-05; b) 10 mL Multi-dose vial NDC 73198-0023-10, Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 2% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, Conroy Rd., Ste. 155, Orlando, FL 32835
Sub Potent
- 2022-03-30FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIIT-105, Papaverine 30 mg/mL Phentolamine 1 mg/mL PGE 10 mcg/mL packaged as a) 5 mL Multi-dose NDC 73198-0005-05; b) 10 mL Multi-dose NDC 73198-0005-10; Each ML contains: 0.5% Chlorobutanol NF, 0.0005% Edetate Disodium Dihydrate USP, 1.84% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 0.5% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835.
Super Potent
- 2022-03-30FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IIIFormula F9, Papaverine 0.9 mg/mL, Phentolamine 0.1 mg/mL, PGE 20 mcg/mL, Atropine 0.01 mg/mL, Multi-Dose 10 mL vial, Each ML contains: 0.5% Chlorobutanol NF, 0.005% Edetate Disodium Dihydrate USP, 2.74% Benzyl Alcohol NF, 5% Mannitol USP, 1% Sodium Metabisulfite NF, 1% Ethyl Alcohol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0004-10
Sub Potent
- 2022-03-30FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IINAD+ Nicotinamide Adenine Dinucleotide, Lyophilized powder for reconstitution, Multi-Dose 500 mg per vial, Each ML contains: 0.288% Sodium Phosphate Monobasic USP, 0.42% Sodium Phosphate Dibasic USP, 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals 6700 Conroy Rd., Ste. 155, Orlando, FL 32835 NDC: 73198-0083-00
Product found to be Sub Potent or Exceeded reconstitution time
- 2022-03-30FDA-DrugOlympia Compounding Pharmacy dba Olympia PharmacyClass IISermorelin Acetate Lyophilized powder for reconstitution, Multi-Dose 9 mg per vial, Each ML contains: 5% Mannitol USP, Sterile Water for Injection USP, Rx Only, Olympia Pharmaceuticals, 6700 Conroy Rd., Ste. 155, Orlando, FL 32835. NDC 73198-0059-00
Sub Potent
- 2022-03-30FDA-DrugAkorn, Inc.Class IITheraTears Extra (sodium carboxymethylcellulose) 0.25% Lubricant Eye Drops, 30 Sterile Single-Use Vials per box, Akorn Consumer Health, A Division of Akorn, Inc., Ann Arbor, MI 48105. NDC 58790-010-30
Lack of Assurance of Sterility
- 2022-03-30FDA-DrugRock Town Distillery, Inc.Class IIROCK TOWN - DISTILLERY - HAND SANITIZER, Alcohol Antiseptic 70%, Topical Solution packaged in a) 375 mL (12.7 fl. oz.), NDC 74492-0002-1; b) 3785 mL/1 gallon NDC 74492-0002-2; c) 236 mL/8 oz. NDC 74492-0002-3; d) 473 mL/16 oz. NDC 74492-0002-4; Made in USA Rock Town Distillery, 1201 Main Street Little Rock, Arkansas 72202
CGMP Deviations: FDA analysis found product to contain acetal and acetaldehyde above specification limits.
- 2022-03-30FDA-DrugDirect RxClass IIDiclofenac Sodium Topical Solution 1.5%, 150 mL, Rx only, Packaged and Distributed by: Direct Rx Dawsonville, GA 30534 Mfg. For SOLA Pharmaceuticals Baton Rouge, LA, NDC 61919-675-05
Defective Container: Leaking containers.
- 2022-03-30FDA-DrugAthenex Pharma Solutions, LLCClass IIEpinephrine Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-814-15
Defective container
- 2022-03-30FDA-DrugAthenex Pharma Solutions, LLCClass IIPhenylephrine HCl Injection in 0.9% Sodium Chloride, 20 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-491-15
Defective container
- 2022-03-30FDA-DrugAthenex Pharma Solutions, LLCClass IIPhenylephrine HCl Injection 50 mg per 250 mL in 0.9% Sodium Chloride, 50 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-494-15
Defective container
- 2022-03-30FDA-DrugAthenex Pharma Solutions, LLCClass IIPhenylephrine HCl Injection 40 mg per 250 mL in 0.9% Sodium Chloride, 40 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-493-15
Defective container
- 2022-03-30FDA-DrugAthenex Pharma Solutions, LLCClass IINorepinephrine Bitartrate Injection 8 mg per 250 mL in 0.9% Sodium Chloride, 8 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-475-15
Defective container
- 2022-03-30FDA-DrugAthenex Pharma Solutions, LLCClass IINorepinephrine Bitartrate Injection 16 mg per 250 mL added to 0.9% Sodium Chloride, 16 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-476-15
Defective container
- 2022-03-30FDA-DrugAthenex Pharma Solutions, LLCClass IINorepinephrine Bitartrate Injection 4mg per 250 mL in 0.9% Sodium Chloride, 4 mg, 250 mL excel bag, Rx only, Athenex Pharma Solutions, LLC, Clarence, NY, 14031, NDC 76154-474-15
Defective container
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IILidocaine Ointment USP, 5%, Net Wt 35.44 g (1 1/4 Oz) tube, Rx Only, Manufactured for: Hi-Tech Pharmacal Co., Inc., Amityville, NY 11701, NDC 50383-341-35.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IILidocaine Cream 4%, Net Wt. 30 grams tube, Distributed by: RUGBY LABORATORIES, 17177 N. Laurel Park Dr., Suite 233, Livonia, MI 48152, NDC 0536-1281-28.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIHydrocortisone Butyrate Lotion, 0.1%, 4 fl oz (118 mL) bottle, Rx only, Manufactured for: SOLA Pharmaceuticals, Baton Rouge, LA 70809, NDC 70512-032-04.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIGentamicin Sulfate Cream USP, 0.1%, packaged in 30 grams tubes, Rx Only, Manufactured for: SOLA Pharmaceuticals, LLC, Baton Rouge, LA 70810, NDC 70512-036-30.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIDiflorasone Diacetate Ointment USP, 0.05%, Net Wt 60 g tubes, Rx only, Manufactured by: Teligent Pharm, Inc., Buena, New Jersey 08310, NDC 52565-063-60.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IIClobetasol Propionate Cream USP, 0.05%, packaged in 60 grams tube, Rx only, Manufactured for SOLA Pharmaceuticals, Baton Rouge, LA 70809; NDC 70512-028-60.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IITriamcinolone Acetonide Ointment USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-014-15; b) 80 grams tubes, NDC 52565-014-80; c) 1 lb (454 g) jars, NDC 52565-014-26; Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IITriamcinolone Acetonide Lotion USP, 0.025%, 60 mL (60 grams) bottle, Rx only, Teligent Pharma, Inc., Buena, New Jersey 08310, NDC 52565-010-59.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
- 2022-03-30FDA-DrugTeligent Pharma, Inc.Class IITriamcinolone Acetonide Cream USP, 0.1%, packaged in a) 15 grams tubes, NDC 52565-056-15; b) 30 grams tubes, NDC 52565-056-30; c) 80 grams tubes, NDC 52565-056-80, d) 1 lb (454 g) jars, NDC 52565-056-26; Rx Only, Teligent Pharma, Inc., Buena, New Jersey 08310.
cGMP deviations: all products within expiry are being recalled because the firm is discontinuing its stability study program.
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