Browse Drug Recalls
1,152 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,152 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 1,152 FDA drug recalls in 2021.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| May 3, 2021 | Sterile Water for Inj., USP, 25 x 100 mL Single Dose Vials per carton, Rx onl... | Presence of Particulate Matter: particulate matter identified as an insect in one vial. | Class II | Pfizer Inc. |
| May 3, 2021 | 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose v... | Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... | Class I | PFIZER, INC |
| May 3, 2021 | 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL ... | Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... | Class I | PFIZER, INC |
| May 3, 2021 | Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 2... | Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 co... | Class III | Mylan Institutional LLC |
| Apr 29, 2021 | NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-coun... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx ... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | Cefixime for Oral Suspension USP 100 mg/5mL, 50mL HDPE bottles, Rx Only, Manu... | Subpotent Drug | Class II | Lupin Pharmaceuticals Inc. |
| Apr 29, 2021 | Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured b... | Presence of Foreign Tablet/Capsule | Class III | Ascend Laboratories LLC |
| Apr 29, 2021 | NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-coun... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 29, 2021 | NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-coun... | Subpotent Drug | Class I | Acella Pharmaceuticals, LLC |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Preferred Pharmaceuticals Inc., Metformin HCl, Extended Release Tab. USP 500 ... | CMGP Deviations: Presence of NDMA impurity detected in product and exceed the Acceptable Daily In... | Class II | Preferred Pharmaceuticals, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | Sodium Chloride 0.9%, USP, 1000 mL, Mfg by: Fresenius Medical Care North Amer... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class II | Fresenius Medical Care Holdings, Inc. |
| Apr 27, 2021 | SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topi... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile To... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 ... | Failed Impurities/Degradation Specifications | Class III | KVK-Tech, Inc. |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile T... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net W... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Top... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.3... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 27, 2021 | Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.... | Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... | Class I | Scentsational Soaps & Candles Inc |
| Apr 26, 2021 | Methylprednisolone Acetate Injectable Suspension USP, 40 mg/mL, 10 mL Multipl... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Haloperidol Decanoate Injection, USP 100 mg/mL, 1 mL Single Dose Vials, Rx On... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial, Rx ... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Leucovorin Calcium for Injection, equivalent to leucovorin 350 mg/vial (20 mg... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 26, 2021 | Haloperidol Decanoate Injection, USP 50 mg/mL, 1 mL Single Dose Vials, Rx Onl... | Lack of Assurance of Sterility | Class II | Teva Pharmaceuticals USA |
| Apr 21, 2021 | Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Heritage Pharmaceuticals Inc |
| Apr 20, 2021 | BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate... | Defective Delivery System: An increase in complaints identified endcap being loose or falling off... | Class I | CareFusion 213, LLC |
| Apr 20, 2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total vo... | Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA)... | Class III | Genentech Inc |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laborato... | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... | Class III | SigmaPharm Laboratories LLC |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laborator... | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... | Class III | SigmaPharm Laboratories 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.