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 |
|---|---|---|---|---|
| Jun 2, 2026 | Lucky Super Soft, Antifungal Athlete's Foot Cream, Clotrimazole 1% Cream, Net... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, Bacitracin Zinc Ointment, 1oz (28.3g) per tube, 72 tubes per case,... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Lucky Super Soft, First Aid Triple Antibiotic Ointment, Bacitracin zinc 400 u... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc (equivalent to 400 uni... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Rapidol, Triple Antibiotic First Aid Ointment, Bacitracin Zinc 400 units, Neo... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 1 oz (28.3g) tubes, Manufactured ... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 1, 2026 | Minocycline Hydrochloride Extended-Release Tablets, USP, 115 mg, 30-count bot... | Failed Dissolution Specifications: An out-of-specification (OOS) result was observed during the 9... | Class II | Ascend Laboratories, LLC |
| May 29, 2026 | Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 16 oz, 474 mL, Distribu... | Subpotent drug | Class II | Gasco Industrial Corp. |
| May 29, 2026 | Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), ... | Subpotent drug | Class II | Gasco Industrial Corp. |
| May 29, 2026 | Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: ... | Subpotent drug | Class II | Gasco Industrial Corp. |
| May 29, 2026 | Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distrib... | Subpotent drug | Class II | Gasco Industrial Corp. |
| May 29, 2026 | Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 13... | Subpotent drug | Class II | Gasco Industrial Corp. |
| May 29, 2026 | Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured... | Subpotent drug | Class II | Gasco Industrial Corp. |
| May 29, 2026 | GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets... | Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was o... | Class II | Golden State Medical Supply Inc. |
| May 29, 2026 | Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampu... | Presence of Foreign Substance:This recall has been initiated in response to a product quality com... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 28, 2026 | BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ... | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... | Class II | CareFusion 213, LLC |
| May 28, 2026 | Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Aja... | CGMP Deviations | Class II | Ajanta Pharma USA Inc |
| May 28, 2026 | BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... | Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... | Class II | CareFusion 213, LLC |
| May 28, 2026 | KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-c... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 7... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chew... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 ... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, ... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 7... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 ... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count b... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 ... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewabl... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewa... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewab... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewab... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-co... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chew... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS,... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewabl... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 28, 2026 | HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-c... | Presence of foreign substance: small metallic particles in chewable tablets. | Class II | Guardian Drug Co. Inc. |
| May 27, 2026 | Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg... | Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specif... | Class II | Glenmark Pharmaceuticals Inc., USA |
| May 27, 2026 | Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pha... | Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as A... | Class II | Ajanta Pharma USA Inc |
| May 27, 2026 | Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Di... | Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolutio... | Class II | Lannett Company Inc. |
| May 22, 2026 | Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPh... | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 22, 2026 | Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPh... | Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 22, 2026 | Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters... | Microbial contamination of sterile products | Class II | Zep Inc |
| May 21, 2026 | Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Con... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry F... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
| May 21, 2026 | Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ ... | Defective container:may contain bottles with incomplete seals | Class II | Keystone Industries |
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.