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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
Apr 2, 2019 Serum Tears 50% Ophthalmic Drops, 1 mL Dropper, Anderson Compounding Pharmacy... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 20:25:1 Injection, 2 mL Vial, Anderson Compounding Phar... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Tri-Mix 20:30:1, 10 mL Vial, Anderson Compounding Pharmacy 310 ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Prostaglandin Quad with Atropine 10:30:1:0.15, 2 mL Vial, Anderson Compoundin... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Sermorelin 0.3 mg/0.5 mL, 10 mL Vial, Anderson Compounding Pharmacy 310 Bluff... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 20,000 U/Lidocaine 2% 10 mL/Sodium Bicarbonate 8.4% 10 mL/Sterile Wat... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 10 mL/ Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/ Normal Sali... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 DMSO 50% 60 mL/Heparin 1 mL/ Sodium Bicarbonate 60 mL/ Solu-Cortef 100 mg, 41... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Vitamin D3 200,000 IU/mL Injection, 2 mL Vial, Anderson Compounding Pharmacy ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 10 mL/Marcaine 0.25% 20 mL/Sodium Bicarbonate 40 mL/Normal Saline 5 m... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 23 Day, 2876 Units/4.6 mL Vial, Anderson Compounding Pharmacy 310 Bluff C... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 10 mL/Marcain 0.25% 20 mL/Sodium Bicarbonate 8.4%-40 mL/per 70 mL, An... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 Heparin 2 mL/Lidocaine 2%-10 mL/Sodium Bicarbonate 8.4%-5mL/ Sterile Water 10... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Apr 2, 2019 HCG 4,100 Units/vial Injection, Anderson Compounding Pharmacy 310 Bluff City ... Lack of sterility assurance. Class II Anderson Compounding Pharmacy, Inc. DBA Anderso...
Mar 5, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 50 mg/12.5 mg 50 Tabl... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 5, 2019 Losartan Potassium Tablets USP 50 mg 50 Tablets (5x10) Unit Dose boxes, Rx On... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 5, 2019 Losartan Potassium and Hydrochlorothiazide Tablets, USP 100 mg/12.5 mg 50 Tab... CGMP Deviations: presence of an impurity, N-Methylnitrosobutyric acid (NMBA) was identified Class II AVKARE Inc.
Mar 1, 2019 Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 4... Failed Dissolution Specifications Class III AVKARE Inc.
Feb 20, 2019 Topical Solution USP Hydrogen Peroxide First Aid Antiseptic Oral Debriding Ag... Cross Contamination: Presence of IPA in finished product. Class II Vi-Jon, Inc.
Jan 16, 2019 Docusate Sodium, 100mg softgels, packaged in 10 x 10 unit dose blister cards,... Labeling: Label mix-up: Secondary carton may be labeled as Gabapentin 300mg instead of Docusate S... Class II Rx Pak Division of McKesson Corporation
Dec 17, 2018 Progesterone 100 mg SR capsules, 30-180 capsules per prescription, Rx only, ... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Promethazine Gel 50 mg/mL, 1cc to 10cc per prescription, Rx only, Duren's He... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Omeprazole 4 mg/mL Suspension, 150cc to 300 cc per prescription, Rx only, Du... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Testosterone 0.1% cream, 30 grams, Rx only, Duren's Health Mart Pharmacy 215 ... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Progesterone 10% cream, 12gm to 30gm per prescription, Rx only, Duren's Healt... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Dec 17, 2018 Domperidone 10 mg capsules, 100-count per prescription, Rx only, Duren's Hea... Lack of Processing Controls. Class II Duren Health Mart Pharmacy
Nov 20, 2018 Germ Bloc Health Hand Sanitizer Foam (benzalkonium chloride 0.13%) 7.5fl.oz./... Microbial Contamination of Non-Sterile Product: Presence of Pseudomonas aeruginosa in product Class II AVKARE Inc.
Aug 14, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/mL, 10 mL (10 mL UD cups in box... Supterpotent Drug Class II Mckesson Corporation
Aug 14, 2018 Valsartan Tablets, USP 80 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-78... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Aug 14, 2018 Valsartan Tablets, USP 320 mg Rx Only 30 Tablets (6x5) Unit Dose NDC 50268-78... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Aug 14, 2018 Valsartan Tablets, USP 160 mg Rx Only 50 Tablets (5x10) Unit Dose NDC 50268-7... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Aug 14, 2018 Valsartan Tablets, USP 40 mg Rx Only NDC 50268-783-15 50 Tablets (5x10) Unit ... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II AVKARE Inc.
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/25 mg tablets 90-count bottle... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 80 mg/12.5 mg tablets, 90-count bott... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 160 mg/25 mg tablets, 90-count bottl... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Jul 18, 2018 AvKARE Valsartan and Hydrochlorothiazide 320 mg/12.5 mg tablets, 90-count bot... CGMP Deviations: Carcinogen impurity detected in API used to manufacture drug product. Class II Avkare Incorporated
Mar 30, 2018 Amantadine HCl Capsules, USP, 100 mg, 50 Capsules (5x10) Unite Dose, Rx Only,... Failed Dissolution Specifications Class II AVKARE Inc.
Jan 12, 2018 HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial,... Non-Sterility Class I The Compounding Pharmacy of America
Jan 3, 2018 Lovastatin Tablets USP, 40 mg, 50 Tablets (5x10) Unit Dose carton, Rx only, M... Failed Dissolution Specifications: Low out of specification results for dissolution during annual... Class II AVKARE Inc.
Oct 13, 2017 Hydromorphone HCl 0.5 mg per mL in 0.9% Sodium Chloride Injection 1 mL, packa... Superpotent drug: out of specification result for potency Class II PharMEDium Services, LLC.
Oct 6, 2017 Duloxetine Delayed-release Capsules USP, 20 mg, 50 Capsules (5 x 10) Unit Dos... Failed Impurities/Degradation Specifications: slightly elevated levels of phthalic acid. Class II AVKARE Inc.
Sep 13, 2017 Magnesium Citrate Oral Solution Lemon Flavor, 1.745g per fl oz, packaged in ... Failed Impurities/Degradation Specifications. Class III Vi-Jon, Inc.
Sep 13, 2017 Equate Beauty Clarifying Face Daily Moisturizer 4 fl. oz. (118 mL) Distribute... Failed Stability Specifications Class III Vi-Jon, Inc.
Sep 13, 2017 Magnesium Citrate Oral Solution Cherry Flavor, 1.745 g per fl oz, packaged in... Failed Impurities/Degradation Specifications. Class III Vi-Jon, Inc.
Jul 19, 2017 Voriconazole Tablets, 200 mg, 20-count cartons (4 x 5) Unit Dose, Rx only, Ma... Failed impurities/degradation specifications: Out of specification for a related compound C. Class III AVKARE Inc.
Jul 17, 2017 Magnesium Citrate Oral Solution, packaged in a 10 fl. oz. (296 mL) glass bott... Microbial contamination of non-sterile products: product was found to contain mold, identified as... Class II Vi-Jon, Inc.
Jun 12, 2017 Magnesium Citrate Saline Laxative Cherry Flavored, packaged in a) 10 fl. oz. ... Presence of foreign substance: glass particle Class II Vi-Jon, Inc.
Feb 15, 2017 Famciclovir tablets, 500 mg, packaged in 30-count unit dose cartons, Rx only,... Failed impurities/ degradation specifications: Product was above specification for unknown impuri... Class II AVKARE Inc.
Dec 12, 2016 VirtPrex Prenatal/Postnatal Tablets, Prescription Supplement Containing Folic... cGMP Deviations: Active Pharmaceutical Ingredient (API) manufacturer is on FDA Import Alert. Class III VIRTUS PHARMACEUTICALS OPCO II L

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.