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Browse Drug Recalls

6,250 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 6,250 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 6,250 FDA drug recalls.

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DateProductReasonClassFirm
Feb 10, 2017 MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / P... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 49... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arb... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETIN... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Dec 15, 2016 AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused p... Lack of Assurance of Sterility: Potential cracks in glass vials Class II Amgen, Inc.
Dec 15, 2016 Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bot... Lack of Sterility Assurance Class II Meta Pharmacy Services
Dec 13, 2016 Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immu... Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled... Class I Pacific Medical Solutions
Dec 6, 2016 Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. Class II Baxter Healthcare Corporation
Nov 18, 2016 Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial,... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Si... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose ... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only,... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Si... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride (20 mg/mL) in 0.9% Sodium Chloride 500 mL Bag, Rx Only, Sing... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Heparin Sodium 5,000 USP Units Added to 0.9% Sodium Chloride 1,000 mL* Bag (5... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Glycopyrrolate 1 mg/5 mL (0.2 mg/mL) Injection Solution, 5 mL Single-Dose Syr... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Neostigmine Methylsulfate 5 mg/5 mL Injection Solution, 5 mL (1 mg/mL) Single... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Rocuronium Bromide 50 mg/5 mL Injection Solution, 5 mL (10 mg/mL) Single-Dose... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Fentanyl Citrate 2 mcg/mL & Bupivacaine HCl 0.125% in 0.9% Sodium Chloride, 1... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Midazolam HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL), Single-Dose Syri... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Hydromorphone HCl 1 mg/mL in 0.9% Sodium Chloride 30 mL PCA Vial (1 mg/mL), S... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Phenylephrine HCl 1 mg/10 mL (100 mcg/mL) in 0.9% Sodium Chloride, 10 mL Sing... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Morphine Sulfate 1 mg/mL in 0.9% Sodium Chloride, 100 mL Bag, Single-Dose Bag... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 18, 2016 Calcium Chloride 1 g/50 mL* Added to 5% Dextrose (20 mg/mL)*, Single-Dose Bag... Lack of Assurance of Sterility - the firm is recalling select sterile drug products. Class II Cantrell Drug Company
Nov 17, 2016 TriMix, Alprostadil/Phentolamine/Papaverine 40mcg/2mg/60mg/mL, (1 ML). Compo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Propionate 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Lipotropic (L-Carnitine 170 mg + Methylcobalamin 300 mcg + Thiamine HCL 20 mg... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ultra Amino Blend (Arginine HCL 105 mg + Lysine (L) HCL 150 mg + Ornithine (L... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Ultra Amino Energy Cocktail (Methionine (L) 12.5mg/Inositol 25mg/Choline Chlo... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 BiMix Phentolamine/Papaverine 1 mg/30 mg/mL (1 ML). Compounded by Tri-Coast ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Glutathione 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Sermorelin Acetate 6 mg. Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Glucosamine 200 mg/mL (30 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 BCAA (30 ML) (Isoleucine (L) 15 mg + Leucine (L) 10 mg+ Valine 40 mg+ Lidocai... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Testosterone Suspension 100 mg/mL, (5 ML). Compounded by Tri-Coast Pharmacy Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 Quad Mix, Alprostadil/Phentolamine/Papaverine/Atropine 10mcg/2mg/30mg/200mg/m... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy
Nov 17, 2016 IV Cocktail #2 (Ascorbic Acid 200 mg+Vitamin A Acetate 330 IU+Vitamin D3 200 ... Lack of Assurance of Sterility Class II Tri-Coast Pharmacy

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.