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Browse Drug Recalls

420 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 420 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 420 FDA drug recalls in VA.

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DateProductReasonClassFirm
Apr 13, 2022 Ampicillin for Injection, USP, 1 g per vial, 10-count box, Rx only, Distribut... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Triamcinolone Acetonide cream, USP, 0.1% ,15 grams tube, Rx only, MFG: Sando... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Labetalol Hydrochloride Tablets, USP, 100 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Doxycycline Hyclate Tablets, USP, 100 mg, 50-count carton (10 tablets each bl... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 MethyLPREDNISolone Acetate Injectable Suspension, USP, 40 mg/mL, packaged in ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Promethazine HCl Tablets, USP, 25 mg, 100-count unit dose box, Rx only, MFG: ... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Proventil HFA, (Albuterol Sulfate Inhalation Aerosol), 200 metered inhalatio... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Epinephrine, ABJT 0.1 mg/mL, 10 mL, 20GX1.5 (10 pack), Rx only, MFG: Pfizer,... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Naltrexone Hydrochloride Tablets, USP, 50 mg, 100-count bottle, Rx only, MFG:... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Bupivacaine Hydrochloride, USP 0.5% (5mg/mL), 25 vials x 50 mL per box, Rx on... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Metronidazole tablets, USP 250 mg, 100-count unit dose box, Rx only, MFG: Maj... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Intralipid (I.V. Fat emulsion), 20%, 250 mL bag, Rx only, MFG: Baxter Healthc... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Dexmedetomidine HCL Single Dose Vial 200 mcg per 2 mL (100mcg/mL), Rx only, M... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Spinal Tray (A4058-25 Spinal Tray 25G Whitacre No Epinephrine), Rx only, Manu... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 GlucaGen (glucagon) for injection, 1 mg per vial, single dose kit, Rx only, M... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Duraclon (clonidine HCl injection, USP), 1000 mcg/10 mL (100 mcg/mL), 10 mL s... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Cefazolin for injection USP, and Dextrose Injection, USP, 2 g, 50 mL duplex c... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Apr 13, 2022 Thrombin JMI, Vial 5,000IU 2/diluent, kit, Rx only, MFG: Pfizer NDC 60793-2... cGMP deviations: Temperature abuse Class II Mckesson Medical-Surgical Inc. Corporate Office
Feb 18, 2022 All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores ... CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Class II Dollar Tree Distribution, Inc.
Mar 26, 2021 Thumbs Up 7 Red 70K, 10 count blister pack cartons, Distributed by Ummzy LLC.... Marketed without Approved NDA/ANDA: FDA analysis results obtained the presence of sildenafil and ... Class II Antoto-K
Sep 3, 2020 Leafree Instant Hand Sanitizer Aloe Vera (ethyl alcohol 70% v/v), Kills 99.99... Marketed without an Approved NDA/ANDA; product labeled as Edible Alcohol rendering the product an... Class I CORGIOMED LLC
Jul 3, 2020 Metformin Hydrochloride Extended-Release Tablets USP, 750 mg, a) 100 ct. bott... CGMP Deviations: FDA analysis detected N-Nitrosodimethylamine (NDMA) impurity above the acceptabl... Class II Granules Pharmaceuticals Inc
Mar 8, 2017 hydrALAZINE HYDROCHLORIDE INJECTION, USP, 20 mg/mL, 1 mL Single Dose Vial, pa... Temperature Abuse: Certain pieces of these lots distributed by McKesson Medical Surgical Inc. wer... Class II Mckesson Medical Surgical
Jan 27, 2017 MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 ... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Mad... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) t... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMI... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxid... CGMP Deviations Class II Cherry Hill Sales Co.
Sep 29, 2015 Ultimate Herbal Slimcap Capsules, 350 mg*, 30-count bottles, labeled Part 1 o... Marketed Without An Approved NDA/ANDA: product marketed as a dietary supplement was found to be t... Class I Fit Firm and Fabulous
Sep 18, 2015 MORPHINE 10MG/ML in NS, Packaged in a) 150ML Homepumps and b) 250ML Homepumps... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFTRIAXONE in NS, Packaged as a) 1GM in 50ML Homepumps, b) 2GM in 100ML Home... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CUBICIN (daptomycin) in NS, Packaged as a) 350MG in 7ML Syringes, b)365MG in ... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 FLUCONAZOLE IN NACL 400MG in NS, Packaged in 200ML Homepumps, Rx Only. SENTAR... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 POTASSIUM CHLORIDE in D 5 1/2NS, Packaged in a) 40 mEq KCL/LITER 1000ML Homep... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 CEFEPIME, Packaged a) 1GM in 50ML Homepumps, b) 2GM in 100ML Homepumps, and c... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ONDANSETRON HCL 8MG, Packaged in 100ML Homepumps. Rx Only. SENTARA HOME HEALT... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MEROPENEM in NS, Packaged as a) 1000MG in 250ML Homepumps, and b) 2GM in 100M... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Parenteral Amino Acid Infusion 10%, Packaged in a) 780ML Homepumps, b) 1000ML... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 INTRALIPID (fat emulsion), Packaged in a) 27ML Homepumps, b) 125ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 GENTAMICIN, Packaged as a) 70MG in 70ML Homepumps, b) 80MG in 80ML Homepumps,... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 DOBUTAMINE HCL in D5W, Packaged as a) 240MG in 60ML Homepumps and b) 1520MG i... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 SOLUMEDROL (methylprednisolone succinate) 1GM in NS, Packaged in 100ML Homepu... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Cancidas (caspofungin acetate) 58.4MG in NS, Packaged in 116.8ML Homepumps, R... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 VANCOMYCIN HCL, Packaged as: a) 600MG in 120ML Homepumps, b) 750MG in 150ML H... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 ZOSYN (pipericillin/tazobactam) in NS, Packaged as a) 3.375GM in 50ML Homepum... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 MYCAMINE (micafungin sodium) 150MG, Packaged in 150ML Homepumps, Rx Only. SEN... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Tobramycin 120MG, Packaged in 150ML Homepumps, Rx Only. SENTARA HOME HEALTH S... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 Ampicillin/Sulbactam 12GM in NS, Packaged in 600ML Homepumps, Rx Only. SENTAR... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 GANCICLOVIR in NS, Packaged as a) 320MG in 64ML Homepumps and b) 2440MG in 48... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises
Sep 18, 2015 SOD CHLORIDE (Sodium Chloride), Packaged in a) 0.9% in 30ML Homepumps, b) 0.9... Lack of Assurance of Sterility: Product sterility cannot be guaranteed. Class II Sentara Enterprises

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.