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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
Mar 22, 2018 Pregnenolone 100 mg (SD) pellet, amber vial, Rx only, Partell Specialty Pharm... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Finasteride/Anastrozole 120 mg/10 mg/4 mg pellet Amber vial, Rx ... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Methylcobalamin 12.5 mg/mL, Injectable Liquid, packaged in a) 5 mL amber vial... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 HCG 1000 units/mL, packaged in a) 2 mL and b) 6 mL amber vial, Rx only, Parte... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Methionine15mg/Inositol 50mg/Choline 100mg, packaged in a) 5mL and b) 50 mL a... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #4 (ALP 20/PAPAV/PHENT 2), 3 mL amber vial, Rx only, Partell Specialty Pha... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Biotin Suspension 10mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone/Anastrozole 120 mg/8 mg pellets packaged in amber vial, Rx only,... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #6 (ALP 25/PAPAV/PHENT1), 3 mL amber vial, Rx only, Partell Specialty Ph... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 200 mg pellet packaged in amber vial, Rx only, Partell Specialty... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 15 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Lipoic Acid 25mg/mL, 5 mL amber vial, Rx only, Partell Specialty Pharmacy, 58... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 MVI-7 (B1-100mg/B3-100mg, B5-252 mg, B6-102mg, Vit C-2500 mg, B12-10mg, Mag-1... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 55 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Nandrolone decanoate 200mg/mL, 5 mL amber vial, Rx only, Partell Specialty Ph... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 TM #1 (ALP 5.9/PAPAV 17.65/PHEN 0.59) Injectable solution, packaged in 3 mL a... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Estradiol 55 mg (SD) pellets in amber vial, Rx only, Partell Specialty Pharma... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Mar 22, 2018 Testosterone 50 mg pellet packaged in amber vial, Rx only, Partell Specialt... Lack of Assurance Sterility: Firm is recalling various drug products due to a non-approved method... Class II Partell Specialty Pharmacy
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 5, 2018 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Jan 16, 2018 DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Si... Lack Of Assurance Of Sterility Class II Sun Pharmaceutical Industries, 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
Dec 27, 2017 HYDROmorphone HCl in 5% Dextrose in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Rocuronium Bromide in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate in 0.9% Sodium Chloride in all strengths, all doses, and all... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Glycopyrrolate in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Potassium Chloride in 0.9% Sodium Chloride in all strengths, all doses, and a... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Labetalol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 HYDROmorphone HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Nicardipine HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Atropine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Esmolol HCl in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate and Ropivacaine HCl in 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 HYDROmorphone HCl in Sodium Chloride 0.9% in all doses, all strengths, and al... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ketamine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pac... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ephedrine Sulfate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ketamine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Labetalol HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ropivacaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all ... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Ropivacaine HCl Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Lidocaine HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Fentanyl Citrate Injection in all strengths, all doses, and all packaging. Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Methadone HCl in 0.9% Sodium Chloride in all strengths, all doses, and all pa... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses... Lack of sterility assurance. Class II Pharmedium Services, LLC
Dec 27, 2017 Neostigmine Methylsulfate Injection in all strengths, all doses, and all pack... Lack of sterility assurance. Class II Pharmedium Services, LLC

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.