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Browse Drug Recalls

24 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 24 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 24 FDA drug recalls.

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DateProductReasonClassFirm
May 17, 2018 Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 EDTA Disodium 30 mg/mL PF. Rx Only. Packaged in 1 mL pre filled syringe. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Magnesium Sulfate 200 mg/mL, 100ml. Rx. Only. Packaged in 100 mL MDV vials. C... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL vials. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Methylcobalamin 1000 mcg/mL 100 mL. RX Only. Packaged in 100ml MDV vials. Com... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Fentanyl Citrate 50 mcg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Medroxyprogesterone 150 mg/mL 5ml. Rx Only. Packaged in 5 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 550 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 B-Complex Rx only. packaged in a) 100 mL bag b) 100 ml MDV vial. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ropivacaine HCl 2 mg/mL 400 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glycopyrrolate 0.2 mg/mL 2ml. Rx Only. Packaged in 2 mL syringes. Compounded ... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Cefazolin 2 Gm/20 mL 20 ml. Rx Only. Packaged in 20 mL syringes. Compounded G... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 MIC "B" COMBO LIPOTROPIC 50 ml. Packaged in a 50ml MDV vial. Compounded Guard... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Morphine Sulfate 1 mg/mL CADD 25 mL . RX only. Packaged in a CADD 25 ml. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Phenol 6% with Glycerin Inj 10 ml. Packaged in 10 ml vials. Compounded Guardi... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 500 mL TPN. Rx Only. Packaged in 500 ml bag. Compound... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100 ml. Rx Only. Packaged in 50ml MDV vials. Compounded... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Hyaluronidase 150 units/mL 1ml. Rx Only. Packaged in 1 mL syringes. Refridger... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Ascorbic Acid 500 mg/mL 100 mL vial. Rx Only. Packaged in a 100 ml vial. Comp... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Glutathione 200 mg/mL 100ml. Rx Only. Packaged in 100 mL MDV vials. Compounde... Lack of sterility assurance. Class II Guardian Pharmacy Services
May 17, 2018 Methylene Blue 10 mg/mL 1ml. Packaged in 1 mL syringes. Compounded Guardian P... Lack of sterility assurance. Class II Guardian Pharmacy Services
Sep 23, 2016 Lidocaine HCL/ Sodium Bicarb, 1%/0.5% 0.5 mL SYR PF, packaged in a 3 cc pre-f... Non-Sterility: failed sterility test result. Class I Guardian Pharmacy Services

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.