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 |
|---|---|---|---|---|
| Jun 23, 2021 | LEUKINE (Sargramostim) for Injection, 250 mcg/ vial, 5mL vials, 5 (250 mcg vi... | FAILED STABILITY SPECIFICATION: Out-of-specification (OOS) result observed for Leukine (sargramos... | Class III | Partner Therapeutics 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 22, 2021 | Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., ... | Failed Impurities/Degradation Specifications | Class III | Teligent Pharma, Inc. |
| Jun 22, 2021 | QiYu Hand Sanitizer (ethyl alcohol 75% (v/v)), 16.9 FL OZ (500 ML) bottles, M... | Subpotent | Class II | HOYU(US) LOGISTICS INC |
| Jun 22, 2021 | Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(N... | Failed Impurities/Degradation Specifications | Class III | Teligent Pharma, Inc. |
| 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 |
| Jun 18, 2021 | B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutri... | Superpotent | Class III | Grato Holdings, Inc. |
| Jun 18, 2021 | Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... | Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ... | Class I | Teva Pharmaceuticals USA |
| Jun 16, 2021 | Acetaminophen 325 mg tablets, Regular Strength Pain Reliever, 100-count bottl... | cGMP deviations: Discolored acetaminophen | Class II | Spirit Pharmaceuticals |
| Jun 10, 2021 | Solifenacin Succinate Tablets, 10 mg, 30-count bottles, Rx Only, Manufactured... | CGMP Deviations | Class II | CIPLA |
| Jun 9, 2021 | Chantix (varenicline)Tablets, Contains: 1 Starting Week (0.5 mg* x 11 tablets... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... | Class II | Pfizer Inc. |
| Jun 9, 2021 | Chantix (varenicline) tablets, 1 mg, 56 Tablets, Rx Only, Distributed by Pfiz... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDAs acceptable interim acc... | Class II | Pfizer Inc. |
| Jun 9, 2021 | QiYu Hand Sanitizer Gel, ethanol, 500 mL bottles (pump), Manufacturer Guangzh... | Subpotent | Class II | World Source Llc |
| Jun 9, 2021 | Chantix (varenicline) tablets, 0.5mg*, 56 Tablets, Rx Only, Distributed by Pf... | CGMP Deviations: Presence of the N-nitroso-varenicline impurity above FDA s acceptable interim ac... | Class II | Pfizer Inc. |
| Jun 9, 2021 | Xolair (omalizumab) Injection, 150 mg/1 mL, 1 prefilled syringe, Rx Only, For... | Failed Stability Specifications: Out of Specification results of Polysorbate 20 (PS20) content we... | Class II | Genentech Inc |
| Jun 9, 2021 | Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured... | Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. | Class III | AVKARE Inc. |
| Jun 8, 2021 | Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Ocean... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, Inc. |
| Jun 8, 2021 | Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufacture... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, Inc. |
| Jun 8, 2021 | Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded ... | Labeling: Incorrect Exp. Date: Incorrect BUD. | Class III | Prisma Health Outsourcing Facility |
| Jun 4, 2021 | Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Redd... | Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities | Class III | Dr. Reddy's Laboratories, Inc. |
| Jun 1, 2021 | Metformin Hydrochloride Extended-Release Tablets, USP 750 mg, 100 Tablets, Rx... | CGMP Deviations: Detection of N-Nitrosodimethylamine (NDMA) levels in excess of the Acceptable Da... | Class II | VIONA PHARMACEUTICALS INC |
| May 26, 2021 | Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Dist... | Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units b... | Class III | McKesson Corporation dba McKesson Drug Company |
| May 21, 2021 | DermOtic Oil (fluocinolone acetonide oil) 0.01% Ear Drops 20 mL bottles, Rx ... | Presence of Foreign Substance: Potential for broken glass within the glass pipette of the dropper. | Class II | Hill Dermaceuticals, Inc. |
| May 20, 2021 | Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... | Defective Delivery System: The number of customer complaints for ripping patches and tight releas... | Class II | Noven Pharmaceuticals Inc |
| May 20, 2021 | Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... | Defective Delivery System: The number of customer complaints for ripping patches and tight releas... | Class II | Noven Pharmaceuticals Inc |
| May 18, 2021 | PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per ... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 18, 2021 | maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), D... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 18, 2021 | PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6),... | Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. | Class I | Miracle 8989 |
| May 14, 2021 | Diflorasone Diacetate Ointment USP, 0.05%, packaged in a)15 g (NDC 52565-063-... | Presence of Foreign Substance: Foreign particles observed during routine stability testing. | Class II | Teligent Pharma, Inc. |
| May 14, 2021 | READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) D... | Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate. | Class III | Medline Industries Inc |
| May 13, 2021 | Native Fluoride Toothpaste for Sensitive Teeth, with Fluoride, 5% potassium n... | Labeling: Not Elsewhere Classified; the primary label (tube) may be incorrectly labeled as Fluori... | Class II | Accupac, Inc. |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... | Class I | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED ANTIMICROBIAL Hand Sanitizer Gel with Aloe Vera, (Ethyl Alco... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... | Class II | Global Sanitizers LLC |
| May 12, 2021 | Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only,... | Failed Impurities/Degradation Specifications | Class III | American Health Packaging |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufa... | Class II | Global Sanitizers LLC |
| May 12, 2021 | MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... | Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... | Class I | Global Sanitizers LLC |
| May 11, 2021 | DiBAR LABS Hand Sanitizer, (ethyl alcohol 70%), packaged as a) 16 FL OZ (473.... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Pos... | Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalaf... | Class I | Yamtun7 |
| May 11, 2021 | C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Comp... | Non-Sterility | Class I | People's Custom Rx and Clinical Care, LLC |
| May 11, 2021 | ADVANCE HAND SANITIZER, (ethyl alcohol 70%), 16 FL OZ (473.2 mL), Imported by... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | Imperia Elita Vitaccino Coffee, 10 g sachets, 15 sachets per box, Global Beau... | Marketed without an approved NDA/ANDA: FDA analysis determined presence of the pharmaceutical ing... | Class II | DASH XCLUSIVE |
| May 11, 2021 | ProtectoRx (ethyl alcohol 70%), packaged in a) 2 FL OZ (59 mL), NDC 75408-002... | CGMP Deviations: Other lots and products of hand sanitizer recalled because they were manufacture... | Class II | DIBAR NUTRICIONAL S DE RL DE CV |
| May 11, 2021 | DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut... | Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c... | Class I | DIBAR NUTRICIONAL S DE RL DE CV |
| May 7, 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent and Presence of Particulates . | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 5, 2021 | BusPIRone Hydrochloride Tablets, USP, 15 mg, 100-count bottle, Rx only, Manuf... | Presence of Foreign Tablets/Capsules | Class II | Oxford Pharmaceuticals, LLC |
| May 4, 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, packaged in 500-count bo... | Presence of foreign substance: identified as activated carbon. | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 4, 2021 | Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: ... | Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities | Class III | Dr. Reddy's Laboratories, Inc. |
| May 4, 2021 | Micardis Tablets, (telmisartan Tablets) 80 mg, 30 ct. per folding cartons, Rx... | Subpotent Drug | Class II | Boehringer Ingelheim Pharmaceuticals, Inc. |
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.