Browse Drug Recalls
14,380 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,380 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 14,380 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 31, 2018 | 0.9% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake ... | Lack of assurance of sterility: Bags have potential to leak. | Class II | ICU Medical Inc |
| May 31, 2018 | 0.45% Sodium Chloride Injection, USP, 100 mL bag, Rx Only, Hospira, Inc. Lake... | Lack of assurance of sterility: Bags have potential to leak. | Class II | ICU Medical Inc |
| May 31, 2018 | 0.9% Sodium Chloride Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake ... | Lack of assurance of sterility: Bags have potential to leak. | Class II | ICU Medical Inc |
| May 31, 2018 | 5% Dextrose Injection, USP, 250 mL bag, Rx Only, Hospira, Inc. Lake Forest, I... | Lack of assurance of sterility: Bags have potential to leak. | Class II | ICU Medical Inc |
| May 30, 2018 | Atorvastatin Calcium Tablets, 80 mg*, 90-count bottles, Rx Only, Mfd. By: Dr.... | Presence of Foreign Substance: A product complaint was received for a defective tablet with an em... | Class II | Dr. Reddy's Laboratories, Inc. |
| May 25, 2018 | X-Jow (menthol USP) Pain Gel, 1.25%, packaged in a) 4 oz. (113g) bottles (UPC... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave 3 Step Shaving System, contains one tube Acne Shave (salicylic aci... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave Post-Shave Moisturizer (salicylic acid), 0.5%, 3.3 FL OZ (98 mL) t... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 25, 2018 | Acne Shave (salicylic acid) Shave Cream Acne Shield, 0.5%, 5.1 FL OZ (150 mL)... | CGMP Deviations: products may be contaminated with bacteria. | Class II | Shadow Holdings DBA Bocchi Labs |
| May 22, 2018 | READYFLUSH PROTECT with Dimethicone (3.2%), Flushable Personal Cleaning Cloth... | Microbial Contamination of a Non-Sterile Product. | Class II | Medline Industries Inc (Northpoint 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 |
| 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 | 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 | 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 | 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 | 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 50 ml MDV. Rx Only. Packaged in 50 mL vials. Compounde... | 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 | 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 | 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 | My Way (Levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen... | Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator... | Class II | Lupin Pharmaceuticals Inc. |
| May 17, 2018 | My Way (levonorgestrel) Tablets TWO PACK, 1.5 mg each, packaged as 2 Treatmen... | Marketed Without an Approved NDA/ANDA: 2-pack configuration did not receive appropriate regulator... | Class II | Lupin Pharmaceuticals Inc. |
| 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 | 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 | 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 | 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 550 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 750 mL. Rx Only. Packaged in a ON-Q Pump. Compounded ... | 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 | 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 | 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 | 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 | 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 | 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 | Lidocaine 3% 10 ml. Rx Only. Packaged in 10 mL syringes. Compounded Guardian ... | Lack of sterility assurance. | Class II | Guardian Pharmacy Services |
| May 16, 2018 | screamin' menthol (menthol) Pain Relieving Gel, 4%, packaged in a) 2 OZ (57g)... | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... | Class II | Ideaz Llc |
| May 16, 2018 | Option Systems Antibacterial Foaming Hand Wash with .3% PCMX, 1000 mL pouches... | Microbial contamination of NonSterile Product; FDA analysis returned out of specification results... | Class II | Inopak Ltd |
| May 16, 2018 | screamin' hot (capsaicin) Pain Relieving Gel, 0.03%, packaged in a) 2 OZ (57g... | CGMP Deviations: Products manufactured with an ingredient that exceed the benzene levels allowed ... | Class II | Ideaz Llc |
| May 15, 2018 | Argentum Elixir Colloidal Silver, 50 PPM Homeopathic Infection Fighter, 8 fl... | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... | Class II | MBi Distributing Inc. dba MBi Nutraceuticals |
| May 15, 2018 | Stomach Calm, Calms Upset Stomach and Aids in Treatment of Simple Diarrhea, ... | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... | Class II | MBi Distributing Inc. dba MBi Nutraceuticals |
| May 15, 2018 | Intestinal Colic Drops, Homeopathic Drops for Temporary Relief of Flatulent C... | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... | Class II | MBi Distributing Inc. dba MBi Nutraceuticals |
| May 15, 2018 | Expectorant Cough Syrup, Homeopathic Syrup for Temporary Relief of Cough & Br... | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... | Class II | MBi Distributing Inc. dba MBi Nutraceuticals |
| May 15, 2018 | Nausea Drops, Homeopathic Drops for Temporary Relief of Motion Sickness, Morn... | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... | Class II | MBi Distributing Inc. dba MBi Nutraceuticals |
| May 15, 2018 | Silver-Zinc Throat Spray, HOMEOPATHIC IMMUNE DEFENSE, 50PPM, 4oz/50 ppm/ 120m... | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... | Class II | MBi Distributing Inc. dba MBi Nutraceuticals |
| May 15, 2018 | Teething Drops, Homeopathic Drops for Temporary Relief of Pain Caused by Teet... | Lack of Processing Controls: Firm is voluntarily recalling all lots of homeopathic Teething Drops... | Class II | MBi Distributing Inc. dba MBi Nutraceuticals |
| May 11, 2018 | Scopolamine Transdermal Therapeutic System, 1 mg/3 days, a) 4-count (NDC 4580... | Defective delivery system | Class II | L. Perrigo Company |
| May 7, 2018 | RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottle... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxid... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by ... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical LLC |
| May 7, 2018 | Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, G... | CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... | Class II | RIJ Pharmaceutical 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.