Browse Drug Recalls

989 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 989 FDA drug recall enforcement actions. Each entry includes the product description, reason for recall, classification (Class I through III based on severity), recalling firm, and distribution details. Use the filters below to search by year, classification, state, or keyword.

Drug Safety Recalls

Browse 989 FDA drug recalls in TN.

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DateProductReasonClassFirm
Mar 3, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... Class II Tennessee Technical Coatings, Corp.
Mar 3, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic... Class I Tennessee Technical Coatings, Corp.
Mar 2, 2022 HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 4... Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol a... Class II Vi-Jon, Inc.
Nov 30, 2021 Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methan... Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... Class I Aroma Release Technologies Inc
Sep 9, 2021 Kroger 70% Isopropyl Alcohol First Aid Antiseptic 32 FL OZ (1 QT) 946 mL 5 Di... Labeling: Label Mix-Up.The recall has been initiated after receiving one complaint about incorrec... Class II Vi-Jon, Inc.
Jun 9, 2021 Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured... Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. Class III AVKARE Inc.
May 26, 2021 Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Dist... Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units b... Class III McKesson Corporation dba McKesson Drug Company
May 11, 2021 C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Comp... Non-Sterility Class I People's Custom Rx and Clinical Care, LLC
Dec 7, 2020 Sildenafil Tablets USP 100 mg, Rx Only, 100-count Bottle, Manufactured for: A... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class II AVKARE Inc.
Dec 7, 2020 TraZODONE Hydrochloride Tablets USP 100 mg, Rx Only, 1000-count Bottle, Manuf... Product mix-up: Bottles of sildenafil and trazodone were inadvertently packaged together during b... Class I AVKARE Inc.
Oct 30, 2020 Mesalamine Delayed-Release Tablets, USP 1.2 gram (Once-Daily), 120 Tablets bo... Failed Dissolution Specifications Class II AVKARE Inc.
Sep 2, 2020 pH-D Feminine Health Boric Acid Vaginal Suppositories, 24 vaginal suppositori... Marketed without an Approved NDA/ANDA. Class II pH-D Feminine Health
Aug 3, 2020 Leiper's Fork Distillery, Alcohol Antiseptic Topical Solution, Ethyl Alcohol ... Labeling Not Elsewhere Classified: Product labeled to contain methanol. Class II Leiper's Fork Distillery
Jun 10, 2020 Nystatin Cream, USP 100,000 units per gram, 15 grams, Rx Only, Manufactured a... Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Class II Crown Laboratories
Jun 10, 2020 Nystatin Cream, USP 100,000 units per gram, 30 grams, Rx Only, Manufactured ... Subpotent Drug: Out of specification for assay at the 9-month interval for Nystatin Cream, USP. Class II Crown Laboratories
Jun 4, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 750 mg a) 90 count (NDC... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II AVKARE Inc.
Jun 4, 2020 Metformin Hydrochloride Extended-Release Tablets, USP 500 mg, a) 50 count (ND... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II AVKARE Inc.
May 28, 2020 Lamotrigine Tablets, USP, 150 mg, Rx Only, a) 60 count Bottle, NDC 42291-368-... Presence of Foreign Substance consistent with granules from desiccant packs used during storage Class III AVKARE Inc.
Mar 13, 2020 *Mitomycin 0.04% Ophth DR eye drops, 5 mL bottle, Rx only, Medical Center Ph... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Gentamicin/Bacitracin Bladder Irrigation in N.S., 250 mL bags, Rx only, Me... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Albumin Eye Drop 10% S, packaged in 10 mL bottles, Rx only, Medical Center... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 *Morphine 2 mg/mL Cassette, 100 mL CADD Cassette, Rx only, Medical Center Pha... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Mar 13, 2020 C-*Vancomycin Opthal 14 mg drops, 5 mL bottle, Rx only, Medical Center Pharma... Lack of Assurance of Sterility: due to concerns with production processes which cannot assure ste... Class II Medical Center Pharmacy, Inc.
Jan 7, 2020 Dutasteride Capsules, 0.5 mg, 30 Capsules (6 X 5) Unit Dose per carton, Rx On... Failed Impurities/Degradation Specifications: High out of specification results for related compo... Class II AVKARE Inc.
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 300 mg Rx Only NDC Manufactured for: AvKARE, I... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Nov 14, 2019 AVKARE Ranitidine Tablets, USP 150 mg Rx Only Manufactured for: AvKARE, Inc. ... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Oct 18, 2019 Basic Reset CBD Reset 2400, True Full Spectrum Natural (unflavored), 2400 mg ... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 BIOGENYX True Full Spectrum CBD Oil Cinnamon, 1 fl. oz. (30 mL) bottle, 750 m... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 BIOGENYX True Full Spectrum CBD Oil Wintergreen, 1 fl. oz. (30 mL) bottle, 75... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Nuovi Firming Masque, Renew and Reset, 2 fl. oz. 59 mL bottle, Made in USA ex... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 BIOGENYX True Full Spectrum CBD Oil Natural Flavor, 1 fl. oz. (30 mL) bottle,... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset CBD Reset 750 True Full Spectrum Wintergreen, 750 mg CBD, 1 fl. o... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset CBD Reset 750 True Full Spectrum Natural Flavor 750 mg CBD 1 fl. ... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset Earth Wash Cleaner and Personal Care, Eco Friendly, Non Toxic, 2 ... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset Nuovi Skin Toner, Refined Ionyte, 4 FL. OZ., 118.3 mL bottle, Dis... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Basic Reset CBD Reset 750 True Full Spectrum Cinnamon, 750 mg CBD, 1 fl. oz. ... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 18, 2019 Miracle Facelift Masque, All Natural, The Miracle in a Bottle, 2 fl. oz./60 m... Marketed without an Approved NDA/ANDA Class II Basic Reset Inc.
Oct 17, 2019 AVKARE Ranitidine Hydrochloride Capsules 300 mg 500 Capsules Rx Only NDC 4229... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Oct 17, 2019 AVKARE Ranitidine Hydrochloride Capsules 150 mg 500 Capsules Rx Only NDC 4229... CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API Class II AVKARE Inc.
Sep 6, 2019 Nucala (mepolizumab) Injection, 100 mg/mL Prefilled Syringe, Single-Dose, For... Temperature Abuse; Product stored and shipped outside of labeled storage requirements. Class II Cardinal Health dba Specialty Pharmaceutical Se...
Aug 28, 2019 AVKARE Fexofenadine Hydrochloride Tablets USP Antihistamine 180 mg, 500 Table... Failed Stability Specifications. Class II AVKARE Inc.
May 30, 2019 Trisodium Citrate 0.5% CRRT SOLUTION. RX Only. Rx # specific and Patient Spec... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
May 30, 2019 Memorial Central TPN. Rx Only, Rx # specific and Patient Specific volumes. M... Lack of sterility assurance. Class II Surgery Pharmacy Services Inc
Apr 24, 2019 Losartan Potassium Tablets USP 25 mg 50 tablets (5x10) Unit Dose Rx Only NDC ... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II AVKARE Inc.
Apr 24, 2019 Losartan Potassium Tablets USP 50 mg 50 tablets (5x10) Unit Dose Rx Only NDC ... CGMP Deviations: FDA lab confirmed presence of an impurity, N-Methylnitrosobutyric acid (NMBA) in... Class II AVKARE Inc.
Apr 3, 2019 Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact... Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer) Class III AVKARE Inc.
Apr 2, 2019 Prostaglandin 20 mcg/mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 50:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Phenol 10% Injection, 5 mL Vial, Anderson Compounding Pharmacy 310 Bluff City... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Quad-Mix 20:30:1:0.15 Injection, 10 mL Vial, Anderson Compoundi... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...

Frequently Asked Questions

When a drug safety issue is identified — through FDA inspections, laboratory testing, adverse event reports, or manufacturer quality checks — the responsible company issues a recall to remove the affected products from the market. Pharmacies pull the product from shelves, and consumers are advised to contact their healthcare provider for alternatives.

The leading causes include cGMP deviations, impurity contamination (including nitrosamines like NDMA), failed dissolution or stability testing, sterility issues, potency problems, labeling errors, and foreign particle contamination.

Use the search and filter tools on this page to look up specific medications, active ingredients, or manufacturers. Each recall entry includes the product description, lot numbers, and distribution details.