Browse Drug Recalls
1,723 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,723 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 1,723 FDA drug recalls — Class I.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 21, 2021 | SENNA Syrup (sennosides) 8.8 mg/ 5 mL unit-dose cups, packaged in 24 cups per... | Microbial Contamination of Non-Sterile Product | Class I | Lohxa, LLC |
| Dec 15, 2021 | Clobetasol Propionate Ointment USP, 0.05%, 60g tubes, Rx only, Mfd. by: Taro ... | Microbial Contamination of Non-Sterile Products: presence of R. Pickettii bacteria | Class I | Taro Pharmaceuticals U.S.A., Inc. |
| Dec 6, 2021 | kleantouch HAND SANITIZER (ethyl alcohol 70%), 8.0 FL OZ (236 ML), pump bottl... | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... | Class I | Valisa MFG LLC |
| Dec 3, 2021 | Veklury (remdesivir) for injection, 100 mg/vial, Single-Dose Vial, Rx only, M... | Presence of Particulate Matter: investigation into a customer complaint confirmed the presence of... | Class I | Gilead Sciences, Inc. |
| Nov 30, 2021 | Klean Touch Hand Sanitizer (Ethyl Alcohol 70%) Ingredients Ethanol and Methan... | Marketed Without an Approved NDA/ANDA: Product labeled to contain methanol making it an unapprove... | Class I | Aroma Release Technologies Inc |
| Nov 30, 2021 | Lidocaine Hydrochloride, Topical Solution USP, 4% (40 mg/mL), packaged in 50 ... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Nov 23, 2021 | Old Spice, PURE SPORT, (Aluminum Chlorohydrate 23.5%), Anti-Perspirant & Deo... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, (Aluminum chlorohydrate 23.5%), Antiperspirant, Waterlily,... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Rose, Topica... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, Dry Spray, Aluminum chlorohydrate 23.5%, Antiperspirant, Lavender, To... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Secret, powder fresh, Aluminum chlorohydrate 24%, Anti-Perspirant/Deodorant, ... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE ULTIMATE CAPTAIN, Aluminum Chlorohydrate 23.5%, Ant... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 23, 2021 | Old Spice, SWEAT DEFENSE PURE SPORT PLUS, Dry Spray, (Aluminum Chlorohydrate... | Chemical contamination: presence of benzene | Class I | The Procter & Gamble Company |
| Nov 19, 2021 | AmericanScreening HAND SANITIZER (ethyl alcohol 70%) ANTIMICROBIAL FORMULA Vi... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | American Screening LLC |
| Nov 17, 2021 | Odor-Eaters Spray Powder, Tolnaftate 1% Antifungal, packaged in a) 4 oz. aero... | Chemical contamination: Presence of benzene | Class I | Blistex Inc |
| Nov 17, 2021 | Enoxaparin Sodium Injection, USP, 40 mg/0.4 mL, Single-Dose Syringes with Aut... | Temperature Abuse; temperature excursion during shipping | Class I | Sandoz Inc |
| Oct 26, 2021 | artnaturals hand sanitizer, SCENT FREE HAND SANITIZER (ethyl alcohol 62.5%), ... | Chemical Contamination: presence of benzene, acetaldehyde, and acetal. | Class I | VIRGIN SCENT INC |
| Oct 19, 2021 | Cubicin (daptomycin for injection), 500 mg per vial, Single-dose vial, Rx onl... | Presence of Particulate Matter: Identified as Glass Particles | Class I | MERCK SHARP & DOHME CORP |
| Oct 12, 2021 | Lidocaine Hydrochloride Topical Solution USP 4% (40 mg/mL), 50 mL glass bottl... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Oct 12, 2021 | Methocarbamol 500mg Tablet, packaged in a) #30 count (NDC 7133517952), b) #60... | Labeling: Label Error on Declared Strength; Bottles labeled as Methocarbamol 500 mg Tablets actua... | Class I | Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals |
| Oct 1, 2021 | LOTRIMIN AF (Miconazole nitrate 2%) Deodorant Powder Spray, NET WT 133g (4.6 ... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) POWDER SPRAY NET WT 133g (4.6 oz) can, labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Lotrimin AF (Tolnaftate 1%) Daily Prevention deodorant powder spray, NET WT 1... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Powder Spray, NET WT 133g (4.6 OZ) can,... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) JOCK ITCH POWDER SPRAY NET WT133g (4.6 oz) can, Dist... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | LOTRIMIN AF, (Miconazole nitrate 2%), Jock Itch, Powder Spray, NET WT 133g (4... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) DEODORANT POWDER SPRAY NET WT 133g (4.6 OZ) can, Dis... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Oct 1, 2021 | Tinactin (Tolnaftate 1%) LIQUID SPRAY NET WT150g (5.3 OZ) can, Labeled as (a... | Chemical Contamination: presence of benzene | Class I | Bayer Healthcare Pharmaceuticals Inc. |
| Sep 30, 2021 | Coppertone SPORT MINERAL 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.08%, N... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple baby 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone SPORT Sunscreen Spray 50, (To Deliver) Avobenzone 3%, Homosalate 1... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 30, 2021 | Coppertone Pure & Simple kids 50 Sunscreen Spray (To Deliver) Zinc Oxide 24.0... | Chemical contamination; presence of benzene | Class I | Beiersdorf Inc |
| Sep 24, 2021 | Glucagon Emergency Kit for Low Blood Sugar, Glucagon for Injection, 1 mg per ... | SUBPOTENT DRUG: Vial contained a liquid substance, instead of the expected powder substance. The... | Class I | Eli Lilly & Company |
| Sep 9, 2021 | Ruzurgi (amifampridine) Tablets 10 mg, packaged in 100-count bottles, Rx only... | Microbial contamination of non-sterile products: Firm's testing found lots to exceed specificatio... | Class I | Jacobus Pharmaceutical Company Inc. |
| Sep 3, 2021 | AMINOSYN II 15% An Amino Acid Injection, Sulfite-Free, 2000 mL in flexible co... | Presence of Particulate Matter: Particulate matter identified as fibers, hair, and proteinaceous ... | Class I | ICU Medical Inc |
| Aug 27, 2021 | Avicel RC-591 NF (MCC/Carboxymethylcellulose Sodium) NF, bulk powder, 80.0 KG... | Microbial Contamination of Non-Sterile Product: Out-of-specification results obtained for total a... | Class I | DuPont Nutrition USA, Inc |
| Aug 24, 2021 | Firvanq (vancomycin hydrochloride for oral solution), Vancomycin 50 mg/mL Kit... | Product Mix-up: Incorrect diluent component included in the kit. | Class I | Azurity Pharmaceuticals, Inc. |
| Aug 18, 2021 | X RATED HONEY FOR MEN, packaged in 15g packets, 4 packets per box, UPC 6 1368... | Marketed without an approved NDA/ANDA: Product found to be tainted with Tadalafil. | Class I | Phe Inc |
| Aug 11, 2021 | Hydro Pinapple Burn Max Health Thach Dua, packaged in a box containing 20g x ... | Marketed without an approved NDA/ ANDA - presence of undeclared sibutramine | Class I | Ebay Seller - John Nguyen |
| Aug 10, 2021 | Sodium Bicarbonate in 5% Dextrose Injection, 150 mEq per 1,000 mL (12.6 mg pe... | Non-Sterility: firm's third party lab confirmed microbial contamination. | Class I | SterRx, LLC |
| Aug 3, 2021 | Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx O... | Superpotent Drug | Class I | Teligent Pharma, Inc. |
| Aug 2, 2021 | 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN... | Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... | Class I | Je Dois Lavoir LLC |
| Jul 16, 2021 | ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distrib... | Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil | Class I | Alpha-Tek LLC |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... | Chemical Contamination: presence of benzene | Class I | Johnson & Johnson Consumer, Inc. |
| Jul 14, 2021 | Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... | Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. | Class I | Qikmoov LLC |
| Jul 2, 2021 | Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... | Temperature abuse: the firm received customer complaints of unusual grittiness in the product. | Class I | KVK-Tech, Inc. |
| Jun 22, 2021 | Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured... | Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... | Class I | Ardil Comercial S.R.L. |
| Jun 21, 2021 | Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitiz... | Hand sanitizer packaged in bottles that resemble beverage containers. | Class I | Prairie Wolf Spirits |
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.