Browse Drug Recalls
6,306 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,306 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 6,306 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Estradiol 35 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 | 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 | B-complex (B1-200mg, B2-4mg, B3-200mg,B5-4mg,B6-4mg) /mL, 5 mL 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 | TM #3 (ALP10/PAPAV12/PHENT1), 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 | Progesterone 50 mg (SD) pellets in 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 | 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 | Testosterone/Finasteride 60 mg/5 mg pellet Amber vial, Rx only, Partell Speci... | 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 40 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/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 | Testosterone 40 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 | Testosterone 37.5 mg pellet packaged in amber vial, Rx only, Partell Specia... | 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 | Testosterone 25 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 | Testosterone Propionate 100mg/mL, 5 mL amber vial, Rx only, Partell Special... | 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 | Naltrexone 200 mg pellet, 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 | Methionine 25mg/Inositol 50mg/Choline 50mg/ B12 1mg, packaged in a) 5 mL ambe... | 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 |
| Mar 22, 2018 | Estradiol 20 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 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 10 mg (SD) pellets in 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 | 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 |
| 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 | Vecuronium Bromide in Sterile Water for Injection in all strengths, all doses... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Morphine Sulfate in 5% Dextrose in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| 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 | Dexamethasone Sodium Phosphate added to 0.9% Sodium Chloride in all strengths... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Dexamethasone Sodium Phosphate added to 5% Dextrose in all strengths, all dos... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Midazolam HCl Injection in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Succinylcholine Chloride in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Potassium Chloride in 5% Dextrose in all strengths, all doses, and all packag... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Midazolam 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 | Nicardipine 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 | Ephedrine Sulfate Injection 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 | Labetalol 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 | Lidocaine HCl in all strengths, all doses, and all packaging. | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Ephedrine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and al... | Lack of sterility assurance. | Class II | Pharmedium Services, LLC |
| Dec 27, 2017 | Dexamethasone Sodium Phosphate in all strengths, all doses, and all packaging. | 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 | Morphine Sulfate in 0.9% Sodium Chloride in all strengths, all doses, and all... | 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.