Browse Drug Recalls
17,874 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,874 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 17,874 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 4, 2026 | Duloxetine Delayed-Release Capsules, USP, 60mg, packaged in a) 90 Capsules (N... | CGMP Deviations: Presence of N-nitroso-duloxetine impurity above FDA recommended interim limit | Class II | Breckenridge Pharmaceutical, Inc. |
| Jun 4, 2026 | Gas-X Extra Strength, SIMETHICONE 125 mg/ANTIGAS, packaged in a) 120 SoftGels... | Chemical Contamination: contamination with a diluted propylene glycol-based coolant from a machin... | Class I | Haleon US Holdings LLC |
| Jun 3, 2026 | Primidone Tablets, USP, 50 mg, 100 Tablets per Bottle, Rx only, Manufactured ... | Cross Contamination with Other Products: due to a potential for cross-contamination with Acemetac... | Class III | Amneal Pharmaceuticals, LLC |
| Jun 2, 2026 | hydrOXYzine Hydrochloride Oral Solution, USP, 10 mg/5 mL, 473 mL (1 Pint), Rx... | Presence of foreign substance | Class III | ANI Pharmaceuticals, Inc. |
| Jun 2, 2026 | Total Parental Nutrition - Pediatric PN Patient-Specific TPN Bag, (patient sp... | Incorrect product formulation: bag did not contain copper and famotidine per label. | Class II | Central Admixture Pharmacy Services, Inc. |
| Jun 2, 2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 0.9g packets Net Wt 130g, 144... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Cura Hongos, Crema Antifungica, Clotrimazole 1%, 2oz (57g) tubes, Dist by/por... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Circle K, triple antibiotic ointment, Bacitracin Zinc (400 units), Neomycin S... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, Triple Antibiotic Ointment, Bacitracin Zinc 400 units, Neomycin Su... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, 1% Clotrimazole Antifungal Cream, Net Wt. 1oz (28.3g), Manufacture... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Lil Drug Store, Triple Antibiotic Ointment, Bacitracin Zinc (400 units), Neom... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, Bacitracin Zinc Ointment, 500 units, 1oz (28.3g) tubes, Manufactur... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| Jun 2, 2026 | Med Pride, HYDROCORTISONE CREAM 1%, Net Wt. 16oz (454g) tubes, Manufactured f... | CGMP Deviations; deficiencies observed during FDA inspection | Class II | Dabur India Limited |
| 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 | Fexofenadine Hydrochloride Tablets, USP 180 mg, Antihistamine, 150 Tablets pe... | Failed Impurities/Degradation Specifications | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 1, 2026 | Focalin XR (dexmethylphenidate HCl) 5 mg, 30 extended-release capsules per bo... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Sandoz Inc |
| Jun 1, 2026 | BEEKEEPER'S NATURALS Saline Nasal Spray, Sinus Congestion Rinse, Made with Pr... | Microbial Contamination of Non-Sterile Products | Class I | BEEKEEPER'S NATURALS USA INC. |
| 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 i... | Non-Sterility: Due to presence of Aspergillus penicillioides. And Lack of Assurance of Sterility:... | Class I | CareFusion 213, LLC |
| May 28, 2026 | BD ChloraPrep Clear (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isoprop... | Non-Sterility: Due to presence of Aspergillus penicillioides. | Class I | CareFusion 213, LLC |
| 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. |
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.