Browse Drug Recalls
777 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 777 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 777 FDA drug recalls in 2025.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jun 26, 2025 | Pitavastatin Tablets, 2 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... | Failed Impurity/Degradation Specifications | Class III | AvKARE |
| Jun 26, 2025 | Pitavastatin Tablets, 1 mg, 90 Tablets per bottle, Rx Only, Manufactured for:... | Failed Impurity/Degradation Specifications | Class III | AvKARE |
| Jun 24, 2025 | Metoprolol Succinate Extended-Release Tablets, USP, 25 mg, Packaged in a) 100... | Failed Dissolution Specifications: Product failed to meet dissolution acceptance criteria in the ... | Class II | Granules Pharmaceuticals Inc. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 100 mcg (0.1 mg), 1000-count bottle, Rx On... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 112 mcg (0.112 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 175 mcg (0.175 mg), 1000-count bottle, Rx ... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 50 mcg (0.05 mg), 90-count bottle, Rx Only... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 25 mcg (0.025 mg), 90-count bottle, Rx Onl... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Levothyroxine Sodium Tablets, USP, 150 mcg (0.15 mg), 1000-count bottle, Rx O... | Subpotent Drug: Assay below the approved specification | Class II | ACCORD HEALTHCARE, INC. |
| Jun 20, 2025 | Lisinopril and Hydrochlorothiazide Tablets USP 20mg/12.5mg, 100-count bottles... | Product Mix Up: This product is being recalled because of a complaint received that a sealed bott... | Class II | Lupin Pharmaceuticals Inc. |
| Jun 19, 2025 | Gabapentin Capsules, USP, 100 mg, 10 capsules (10x1) per bag, Rx only, Packag... | Defective container; blister packaging inadequately sealed. | Class II | The Harvard Drug Group LLC |
| Jun 19, 2025 | Gabapentin Capsules, USP, 100 mg, 100 capsules (10x10), blister pack cartons,... | Defective container; blister packaging inadequately sealed. | Class II | The Harvard Drug Group LLC |
| Jun 16, 2025 | 0.9% Sodium Chloride Injection USP, 500 mL, packaged in 500 mL excel containe... | Lack of assurance of sterility: pinholes, within the finger boxes used during Form Fill Seal proc... | Class II | B BRAUN MEDICAL INC |
| Jun 16, 2025 | Lisdexamfetamine Dimesylate Capsules, 60 mg, CII, 100-count bottles, Rx only,... | Failed Dissolution Specifications: An out of specification results observed in dissolution test d... | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jun 16, 2025 | Testosterone 200 mg Pellet packaged in 1mL amber vials, Rx only, Compounded p... | Labeling: Incorrect or Missing Lot and/or Exp. Date: A printing issue resulted in incorrect lot n... | Class III | Qualgen, LLC |
| Jun 11, 2025 | Pitavastatin Tablets, 2 mg, Rx Only, 90 Tablets, Manufactured by: Orient Phar... | Failed Impurities/Degradation Specifications. | Class III | Orient Pharma Co., Ltd. Yunlin Plant |
| Jun 11, 2025 | Famciclovir Tablets, USP 500 mg, 30-count bottles, Rx Only, Manufactured for:... | Presence of Foreign Substance- Black hair strand found attached to a tablet in a sealed bottle. | Class III | Macleods Pharmaceuticals Ltd |
| Jun 11, 2025 | Pitavastatin Tablets, 1 mg, Rx Only, 90 Tablets, Manufactured by: Orient Phar... | Failed Impurities/Degradation Specifications. | Class III | Orient Pharma Co., Ltd. Yunlin Plant |
| Jun 10, 2025 | KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusi... | Subpotent Drug | Class II | IMMUNOCORE, LLC |
| Jun 6, 2025 | ZICAM NASAL ALLCLEAR, 20 Single-Use Swabs per carton, Distributed by Church ... | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Class I | Church & Dwight Inc |
| Jun 6, 2025 | ZICAM COLD REMEDY MEDICATED NASAL SWABS, 20 Single-Use Swabs per carton, Dist... | Microbial Contamination of Non-Sterile Products: Fungal contamination of nasal swabs. | Class I | Church & Dwight Inc |
| Jun 6, 2025 | Orajel Baby, Cooling Swabs for Teething, Each Unit 0.007 fl oz (0.22 mL), NET... | Microbial Contamination of Non-Sterile Products: Fungal contamination of infant oral swabs. | Class I | Church & Dwight Inc |
| Jun 2, 2025 | LIDOcaine HCL Sterile Injection, USP, 20 mg/mL, 2%, (200 mg/10 mL), For Infil... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | Sulfamethoxazole and Trimethoprim Tablets, USP, 400 mg/80 mg, Rx Only, a) 100... | Microbial contamination of non-sterile products: tablets may exhibit black spots due to microbial... | Class I | Amneal Pharmaceuticals, LLC |
| Jun 2, 2025 | LIDOcaine HCl Injection, USP, 10mg/mL, 1% (100 mg/10mL), 10 mL Sterile Single... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | BUPIVAcaine HCL Sterile injection, USP w/EPINEPHRINE 1:200,000, 50 mg/10mL, 0... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | KETAmine Hydrochloride Injection, USP, 500mg/5mL, (10mg/mL), For IM or Slow I... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | LIDOcaine HCL Sterile Injection, USP, 100mg/10mL, 1%, (10mg/mL), w/EPINEPHRIN... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| Jun 2, 2025 | KETAmine Hydrochloride Injection, USP, 50 mg/5mL (10 mg/mL), For IM Use or Sl... | Lack of Assurance of Sterility: A recent FDA inspection revealed concerns with the sterile manufa... | Class II | Tailstorm Health INC |
| May 30, 2025 | TESTO-200, Testosterone Cypionate Inj. USP, 2000mg/10ml (200mg/ml), One 10ml ... | Marketed Without an Approved NDA/ANDA | Class II | Advanced Pharmaceutical Technology, Inc. |
| May 30, 2025 | Icosapent Ethyl Capsules 1 gram, 120 Capsules per Bottle, Rx Only, Manufactur... | Failed Tablet/Capsule specifications; a product complaint was reported for burnt or melted capsul... | Class II | Zydus Pharmaceuticals (USA) Inc |
| May 29, 2025 | Levothyroxine Sodium Tablets, USP 112 mcg (0.112mg), 1000 tablets, Rx Only, M... | Presence of a foreign substance: black hair found embedded in tablet. | Class III | Macleods Pharmaceuticals Ltd |
| May 29, 2025 | Gentamicin Injection, USP, (PEDIATRIC), 20 mg per 2 mL (10 mg per mL*), 2 mL ... | Failed Stability Specifications: Out of specification results for the Color Absorbance test duri... | Class II | Eugia US LLC |
| May 28, 2025 | Brimonidine Tartrate/Timolol Maleate Ophthalmic Solution, 0.2%/0.5%, 15 mL, R... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| May 28, 2025 | Lacosamide Oral Solution, USP, 10 mg/mL, 200 mL, Rx Only, Manufactured by: Ap... | Defective Container: This recall is being initiated due to a leaking unit stored horizontally. | Class II | Apotex Corp. |
| May 28, 2025 | DOBUTamine Injection, USP, 250 mg/20 mL (12.5 mg/mL), 20 mL per Single-dose V... | Discoloration; discolored solution from cracked vials | Class II | Pfizer Inc. |
| May 28, 2025 | Azelastine HCl Ophthalmic Solution, USP, 0.05%, 6 mL, Rx Only, Sterile, Mfg. ... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| May 28, 2025 | Ketorolac Tromethamine Ophthalmic Solution, 0.5%, 10 mL, Rx Only, Manufacture... | Lack of Assurance of Sterility | Class II | Apotex Corp. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 30-count bottle, Rx only, Manufactured by: T... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 27, 2025 | 0.9% Sodium Chloride Injection, USP, Flexible Plastic Container, Rx Only Fres... | Lack of Assurance of Sterility | Class II | Fresenius Medical Care Holdings, Inc. |
| May 27, 2025 | Fluoxetine Tablets, USP, 20 mg, 28-count Carton (4x7 Unit-dose), Manufactured... | CGMP Deviations: Presence of N-Nitroso Fluoxetine exceeding interim acceptable intake limit. | Class II | Torrent Pharma Inc. |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 100 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... | Class II | Ascend Laboratories, LLC |
| May 23, 2025 | Spectrum Advanced Gel Hand Sanitizer, Ethyl alcohol 70%, 8 FL OZ (236 mL) per... | Subpotent product: Product has cloudy appearance and tested below assay label claim for 70% Ethyl... | Class II | Consumer Product Partners, LLC |
| May 23, 2025 | Cephalexin for Oral Suspension, USP, 125 mg per 5 mL, 200 mL (when mixed), Rx... | Failed Impurities/Degradation Specifications An out-of-specification result was observed in the r... | Class II | Ascend Laboratories, LLC |
| May 23, 2025 | Metoclopramide Tablets, USP 10 mg, 100-count bottle, Rx only, Manufactured in... | Presence of foreign tablets/capsules. | Class II | Teva Pharmaceuticals USA, Inc |
| May 22, 2025 | Acetaminophen Tablets, 325 mg, 100-count bottles, Distributed by: Amazon.com ... | cGMP deviations: Due to confirmed consumer complaints received with the observation of tablet dis... | Class II | Aurobindo Pharma USA Inc |
| May 21, 2025 | Nicotinamide adenine dinucleotide (NAD+): 100mg/mL, pre-filled syringe, Thriv... | Lack of Assurance of Sterility | Class II | Thrive Health and Wellness, LLC, dba Thrive Hea... |
| May 21, 2025 | Tirzepatide Injections, 20mg/mL, pre-filled syringe, Thrive Health Solutions,... | Lack of Assurance of Sterility | Class II | Thrive Health and Wellness, LLC, dba Thrive Hea... |
| May 21, 2025 | Semaglutide/Cyanocobalamin Injectable, 5mg/1mg/mL, pre-filled syringe, Thrive... | Lack of Assurance of Sterility | Class II | Thrive Health and Wellness, LLC, dba Thrive Hea... |
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.