Drug and pharmaceutical recalls
17689 federal recalls on file. Federal recalls for prescription drugs, OTC medications, supplements, and pharmaceuticals. Sourced from the FDA and translated into plain English.
- 2022-08-31FDA-DrugFamily Dollar Stores, Llc.Class IINovelty Hand Sanitizer with Silicone Wrap SKU 998890 Novelty Hand Sanitizer Assorted SKU 999330 Purell Hand Sanitizer Essentials 1 FL OZ SKU 2006819 Luxury Hand Sanitizer 16.9 FL OZ SKU 2007723 Suave Hand Sanitizer Lotion 3 FL OZ SKU 2096469 Purell Hand Sanitizer Original 6.5 FL OZ SKU 2095985 Purell Hand Sanitizer Soothing Aloe 6.5 Fluid Ounces SKU 2095986 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022.
CGMP Deviations: product held outside appropriate storage temperature conditions.
- 2022-08-31FDA-DrugAmneal Pharmaceuticals of New York, LLCClass IIDivalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-count bottle, Rx only, Manufactured by: Amneal Pharmaceuticals, India, Distributed by: Amneal Pharmaceuticals, Bridgewater, NJ, NDC 65162-755-10
Failed dissolution specifications.
- 2022-08-24FDA-DrugAkorn, IncClass IIPrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TECH PHARMACAL CO., INC., Amityville, NY 11701. NDC: 50383-042-24
Defective Container: Product has incomplete induction seals.
- 2022-08-24FDA-DrugAire-Master of America IncClass IICommon Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutions, LLC, 344-5 Route 9, Suite 237, Lanoka Harbor, NJ 08734
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIProtect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) per bottle, Manufactured for Protect U Guard, Tampa, FL 33606
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIProtect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per carton, Manufactured for Protect U Guard, Tampa 33606.
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIStage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.) per bottle, Manufactured for 2XL Corporation, 2 Gateway Ct, Ste A, Bolingbrook, IL 60440
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIAvant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) per plastic carton, Manufactured for B4 Brands, Lisbon, Iowa 52253
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugAire-Master of America IncClass IIAvant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) 1000 mL (33.9 fl. oz.) pouch, c) 55 gallon drum, Fragrance Free, Manufactured for B4 Brands, Lisbon, Iowa 62253
CGMP Deviations: product manufactured using deionized water from a system lacking appropriate microbial control post deionization.
- 2022-08-24FDA-DrugNephron Sc IncClass IIKetorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL single dose vials, Rx Only, Nephron Pharmaceutical Corporation 4500 12th Street Extension West Columbia, SV 29172, NDC 0487-6232-01
cGMP Deviations: deviations leading to potential cross-contamination.
- 2022-08-24FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle (NDC 71399-8022-01), b) 1000-count bottle (NDC 71399-8022-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
- 2022-08-24FDA-DrugAkron Pharma, Inc.Class IIIAcetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-8024-01); b) 1000-count bottle (NDC 71399-8024-02), Akorn Pharma Manufactured for: Akorn Pharma, Inc., Fairfield, NJ
Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet.
- 2022-08-24FDA-DrugZydus Pharmaceuticals (USA) IncClass IIFulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled Syringes, Rx Only, Product of India, Manufactured by: Cadila Healthcare Limited, Ahmadabad, India, Distributed by: Zydus Pharmaceuticals (USA ) Inc.m Pennington, NJ 08534, NDC 70710-1688-8.
Failed Impurities/Degradation Specifications
- 2022-08-24FDA-DrugAmerisource Health Services LLCClass IIIAzacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx Only, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213 India. Manufactured for BluePoint Laboratories. NDC 68001-0313-56
Subpotent Drug
- 2022-08-24FDA-DrugBaxter Healthcare CorporationClass IIAcetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container bag, Single Dose Container, For Intravenous Use Only, Rx Only, Baxter Healthcare Corporation, Deerfield, IL 60015 USA; NDC 36000-306-60
Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets indicating "Refrigerate Upon Arrival", however product is labeled to be stored in a controlled room temperature environment.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IIPF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Vial, packaged in 30 x 4 mL Sterile Unit-dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-946-34
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IIPF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL bag, packaged in 10 x 1 IV Bag per case, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-970-05
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IITrisodium Citrate 0.5% Solution, (0.5%/4L), contains Per Liter: Sodium 140 mmol/L, Chloride 86 mmol/L, Citrate 18 mmol/L, 4000 mL IV bag, packaged in 1 x 1 IV bag per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-910-04
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugNephron Sterile Compounding Center LLCClass IIPF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Unit-Dose Vial, packaged in 30 x 3 mL Sterile Unit-Dose Vials per carton, Rx Only, Nephron 503B Outsourcing Facility, 4500 12th Street Extension, West Columbia, SC 29172; NDC 69374-932-33
CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing.
- 2022-08-24FDA-DrugLupin Pharmaceuticals Inc.Class IIRifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured for Lupin Pharmaceuticals, Inc., Baltimore, MD, 21202 NDC: 68180-658-06
CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity.
- 2022-08-24FDA-DrugMEDEK LLCClass IM Hand Sanitizer Ethyl Alcohol Antiseptic 80%v/v, Topical Solution 128 oz/3,785 mL, Made in Mexico by: Grupo Plast-Y-Kosas S.A. de C.V. Puebla 105 Col. Rodriguez Reynosa, Tam, Mexico C.P. 88630, NDC Code: 77797-001-01, Distributed by: Medek, LLC 315 E. Business Hwy 83 Alamo, TX 78516, NDC Code: 75432-001-02.
Chemical Contamination and Subpotent Drug: FDA analysis found product to contain methanol and below label claim for ethanol.
- 2022-08-24FDA-DrugHERON THERAPEUTICS, INC.Class IIIZynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam single dose application, packaged in a kit, Rx only, Manufactured for Heron Therapeutics, Inc., San Diego, CA, NDC 47426-301-02
Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of Zynrelef 400 mg/12 mg kit
- 2022-08-17FDA-DrugTeva Pharmaceuticals USA IncClass IIIAzacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Romania By: Sindan Pharma SRL For BluePoint Laboratories, NDC 68001-313-56
Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for Assay. Results below specification.
- 2022-08-17FDA-DrugSterRx, LLCClass IIfentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) IV bags, Rx Only, SterRx, 141 Idaho Avenue, Plattsburgh, NY 12903, NDC 70324-327-02.
Lack of Assurance of Sterility
- 2022-08-17FDA-DrugSterRx, LLCClass IIFentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV bags, Rx only, SterRx, 141 Idaho Ave., Plattsburgh, NY, 12903, NDC 70324-327-01.
Lack of Assurance of Sterility
- 2022-08-17FDA-DrugStrides Pharma Inc.Class IIPrednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: Strides Pharma Science Ltd., Bengaluru - 562106, India, Distributed by: Strides Pharma Inc., East Brunswick, NJ 08816, NDC 64380-785-06.
Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets
- 2022-08-17FDA-DrugAVKARE Inc.Class IIILamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured for: AvKARE, Inc. Pulaski, TN 38478, NDC 42291-367-10, UPC 3 42291 36710 4
Labeling: Label Error on Declared Strength
- 2022-08-17FDA-DrugCIPLAClass IIDifluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 mL bottles, Manufactured by Cipla Ltd., India, Manufactured for: Cipla USA, Inc., NJ 07059, NDC 69097-341-35.
Lack of Assurance of Sterility: Complaints received of defective container closure.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IIAlcohol Swabsticks, Antiseptic, 50 4" saturated individual packets per box, Manufactured for: Dynarex Corporation, NY 10962, Made in Mexico, NDC 67777-300-01 (current NDC) NDC# 67777-120-10 (discontinued)
CGMP Deviations: products were stored outside the drug label specifications.
- 2022-08-17FDA-DrugMckesson Medical-Surgical Inc. Corporate OfficeClass IISterile Alcohol Prep Pads, Sterile, Latex Free, 100 large pads per box, manufactured for: Dynarex Corporation, NY 10962, NDC 67777-121-16.
CGMP Deviations: products were stored outside the drug label specifications.
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