Browse Drug Recalls
1,749 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,749 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 1,749 FDA drug recalls, Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Berry, 500MG CBD, 1 FL. OZ (30ML) bottles, Dis... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1000MG CBD, 1 FL. OZ (30ML) bottles... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops Hemp Oil Extract, Berry, 1 FL. OZ (30ML) bottles, 300MG CBD, Dist... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Acadia Farms, Equilibrium, vermont maple, 300 MG Hemp Oil, 1 Fl OZ (30 ML) bo... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Pathway To Wellness, CBD Oil, Premium Hemp Oil Drops, Natural, 1000MG CBD, 1 ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Goodness Gurus, Healthy Hemp Drops, 500MG/Berry, 1 FL. OZ bottles, Distribute... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops Hemp Oil Extract, Natural, 1 FL. OZ (30ML) bottles, 500mg CBD, Di... | Chemical Contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Goodness Gurus, Healthy Hemp Drops, 1500 MG/Spearmint, 1 FL. OZ bottles, Dist... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil , Berry Blast, 1000MG CBD, 1... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | BC Hemp Co., Full Spectrum Hemp Extract, CBD Oil, Natural, 1000MG CBD, 1 FL. ... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | A Clean Choice CBD, Hemp Oil Extract Tincture, Strawberry Creme, 1000mg, 1 fl... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Javan Anti Aging and Wellness Institute, CBD Oil, Full Spectrum Hemp Oil, Spe... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Tasty Drops, Hemp Oil Extract, Spearmint, 1500MG CBD,1 FL. OZ (30ML) bottles,... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 18, 2020 | Made by Hemp 1000MG Hemp Extract, Mojito Lime, 1 OZ (30 ML) bottles, Dist by:... | Chemical contamination: product contains elevated levels of undeclared lead. | Class I | MICHIGAN HERBAL REMEDIES |
| Jun 9, 2020 | Minoxidil/Biotin/Spironolactone 1.25/5/25 mg capsule, 90 capsules per bottle,... | Super-potent Drug: This recall has been initiated due to the elevated presence of minoxidil and b... | Class I | MasterPharm LLC |
| May 22, 2020 | NP Thyroid 60, Thyroid Tablets, USP, 1 grain (60 mg), 100-count bottles, Rx O... | Superpotent Drug. | Class I | Acella Pharmaceuticals, LLC |
| May 22, 2020 | NP Thyroid 90, Thyroid Tablets, USP, 1 & 1/2 grain (90 mg), 100-count bottles... | Superpotent Drug. | Class I | Acella Pharmaceuticals, LLC |
| May 22, 2020 | NP Thyroid 30, Thyroid Tablets, USP, 1/2 grain (30 mg), 100-count bottles, Rx... | Superpotent Drug. | Class I | Acella Pharmaceuticals, LLC |
| May 8, 2020 | LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira... | Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matt... | Class I | ICU Medical Inc |
| Apr 20, 2020 | Ketorolac Tromethamine Injection, USP, 30 mg per mL, packaged in 1 mL Single ... | Presence of Particulate Matter - found in reserve sample vials at the firm. | Class I | Fresenius Kabi USA, LLC |
| Apr 18, 2020 | Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Dupl... | Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Pol... | Class I | B. Braun Medical Inc |
| Apr 15, 2020 | KORE ORGANIC CBD Oil Watermelon 15mg*, 30 mL dropper bottles, Handcrafted By ... | Chemical Contamination; product contains elevated levels of lead | Class I | Summitt Labs |
| Apr 14, 2020 | Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Com... | Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain m... | Class I | MasterPharm LLC |
| Mar 23, 2020 | Tetracycline HCL Capsules, USP, 500 mg, 100-count Bottle, Rx Only, Manufactu... | Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... | Class I | Avet Pharmaceuticals, Inc. |
| Mar 23, 2020 | Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactu... | Failed Dissolution Specifications: Out of specification result during long term testing in Tetrac... | Class I | Avet Pharmaceuticals, Inc. |
| Mar 16, 2020 | Phytonadione Injectable Emulsion, USP, 10 mg/mL 1 mL ampule (NDC 43598-405-11... | Defective Container: Recall is due to breaking and shattering of ampules upon opening | Class I | Dr. Reddy's Laboratories, Inc. |
| Mar 16, 2020 | Natural Remedies Active Male 500 mg Male Pleasure Formula Dietary Supplement ... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada... | Class I | Y-O Management LLC, dba Natural Remedy Store |
| Feb 7, 2020 | Phenytoin Oral Suspension USP, 125 mg/5 mL potency, 8 fl oz (237 mL) Rx Only... | Resuspension Problems: Two lots of Phenytoin Oral Suspension USP 125mg/5mL may coagulate and may ... | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 27, 2019 | Ketorolac Trom, 30 mg/1mL Inj. for I.V./I.M. Use, Rx Only, QTY: 1 ml, Repacka... | Presence of Particulate Matter: Medication relabeled at facility was recalled by the manufacturer... | Class I | RemedyRepack Inc. |
| Dec 20, 2019 | Lamotrigine Tablets, USP, 100 mg, Rx Only, 100-count bottle, Mfd. by: Taro P... | Cross Contamination; Lamotrigine Tablets 100 mg USP was contaminated with enalapril maleate. | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 17, 2019 | Bull Platinum 30000 Capsules, 1000 mg, in orange, white, yellow background wi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Ketorolac Tromethamine Injection, USP 30 mg/mL, packaged in 1 mL Single Dose ... | Presence of Particulate Matter: particles identified as polydimethylsiloxane (PDMS) | Class I | Hikma Pharmaceuticals USA Inc. |
| Dec 17, 2019 | Panther Platinum 30000 Capsules, in green, black background with white, red t... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Rhino 7 Platinum 30000 Capsules, in blue,orange,black background with red,whi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 17, 2019 | Stallion Platinum 30000 Capsules in blue,orange,white background with red,whi... | Marketed without an Approved NDA/ANDA; FDA analysis found product to contain tadalfil | Class I | Motto International Corp |
| Dec 6, 2019 | Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, D... | Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total ... | Class I | Lannett Company, Inc. |
| Nov 20, 2019 | Mirtazapine Tablets, USP, 7.5 mg, 500-count tablets, Rx only, Distributed by... | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... | Class I | AuroMedics Pharma LLC |
| Nov 20, 2019 | Mirtazapine Tablets, USP, 15 mg, 500-count tablets, Rx only, Distributed by:... | Labeling: Label Error on Declared Strength; cases labelled Mirtazapine 15mg tablets, 500-count bo... | Class I | AuroMedics Pharma LLC |
| Nov 13, 2019 | Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 ma... | Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil. | Class I | Natures Rx |
| Nov 8, 2019 | UP2, Dietary Supplement, All Natural Libido for Men & Women, a) one pack, b) ... | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovere... | Class I | Med Man Distribution, Inc. |
| Nov 8, 2019 | Bow & Arrow, Dietary Supplement, Libido Enhancer for Men, a) Four pack, b) Te... | Marketed without an Approved NDA/ANDA: Product contains undeclared sildenafil which was discovere... | Class I | Med Man Distribution, Inc. |
| Oct 25, 2019 | 0.9% SODIUM CHLORIDE INJECTION, USP, 250 mL VisIV Container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I | ICU Medical Inc |
| Oct 25, 2019 | LACTATED RINGER'S Injection, USP, 500 mL flexible container, Rx Only, Hospira... | Presence of Particulate Matter. | Class I | ICU Medical Inc |
| Oct 22, 2019 | Green Lumber Natural Fuel For Men capsule, packaged in packs of 2, 4 and 10 c... | Marketed without an Approved NDA/ANDA: FDA analysis found this product to contain undeclared Tada... | Class I | Green Lumber Holdings, LLC |
| Sep 16, 2019 | Mero Macho Artificially Flavored Passion Fruit Vitamin C Liquid Supplement, 2... | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. | Class I | FITOTERAPIA USA, INC |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 100 mcg, 2 pack medication cartr... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 25 mcg/dose, 2 pack cartridges, ... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 50 mcg, 2 pack medication cartri... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 12, 2019 | Natpara (parathyroid hormone) for Injection, 75 mcg, 2 pack medication cartri... | Defective Delivery System: potential risk of rubber stopper particles clogging the needle and lea... | Class I | Shire Human Genetic Therapies, Inc. |
| Sep 6, 2019 | Quinacrine Dihydrochloride (98.25%), bulk API product, packaged in a) 500 g N... | Label Mix-Up: Product labeled as Quinacrine Dihydrochloride; however, after testing, identified a... | Class I | Darmerica, 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.