Browse Drug Recalls
695 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 695 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 695 FDA drug recalls in PA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Nov 12, 2025 | Walgreens Saline Nasal Spray WITH XYLITOL, 1.5 oz (45mL) bottle, DISTRIBUTED ... | Microbial contamination of a non-sterile product - microorganism found to be pseudomonas lactis | Class II | Medical Products Laboratories, Inc. |
| Oct 15, 2025 | Semaglutide Injection, 5 mg/2 mL (2.5 mg/mL), 2mL Multidose Vial, For Subcuta... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 12.5/5mL (2.5 mg/mL), 5mL Multidose Vial, For Subcutan... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Tirzepatide Injection, 27 mg/3 mL (9 mg/mL), 3mL Multidose Vial, For Subcutan... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 8mg/3.2mL (2.5 mg/mL), 3.2mL Multidose Vial, For Subcu... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 2.5mg/1mL (2.5 mg/mL), 1mL Multidose Vial, For Subcuta... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 6mg/2.4mL (2.5 mg/mL), 2.4mL Multidose Vial, For Subcu... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 15, 2025 | Semaglutide Injection, 10 mg/4 mL (2.5 mg/mL), 4mL Multidose Vial, For Subcut... | Lack of Assurance of Sterility | Class II | ProRx LLC |
| Oct 10, 2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Everolimus tablets 10 mg, 28 tablets (each carton contains 4 blister strips w... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Everolimus tablets 2.5 mg, 28 tablets (each carton contains 4 blister strips ... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 10, 2025 | Everolimus tablets 7.5mg, 28 tablets (each carton contains 4 blister strips w... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Oct 9, 2025 | Taoscare Motion Sickness Patches 36-count box, Henan Xinyongtal Medical Techn... | Marketed Without an Approved NDA/ANDA | Class II | ibspot |
| Sep 29, 2025 | Wyandotte, Sanifect E3, Hand Sanitizer (Ethanol-Based, Product 5511), Ethyl A... | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... | Class II | Acuity Specialty Products, Inc. |
| Sep 29, 2025 | AFCO, Hand Sanitizer (Isopropyl Alcohol-Based, Product 5515), Manufactured by... | cGMP deviations: The recall was initiated because required receipt testing of incoming alcohol co... | Class II | Acuity Specialty Products, Inc. |
| Sep 5, 2025 | Everolimus tablets 5mg, 28 tablets (each carton contains 4 blister strips wit... | Failed Impurities/Degradation Specifications: Out of specification for impurity IP-C. | Class III | Endo USA, Inc. |
| Aug 26, 2025 | STERILE WATER FOR INJECTION USP, 3000mL, Rx only, B. Braun Medical Inc., Beth... | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Class II | B BRAUN MEDICAL INC |
| Aug 26, 2025 | 0.9% SODIUM CHLORIDE IRRIGATION USP. ISOTONIC SOLUTION FOR IRRIGATION, 3000mL... | Lack of Assurance of Sterility- Potential for fluid leakage from the port due to port misalignment. | Class II | B BRAUN MEDICAL INC |
| Aug 18, 2025 | Lactated Ringers's Injection USP, 1000 mL container, Rx only, B. Braun Medica... | Presence of Particulate Matter | Class I | B BRAUN MEDICAL INC |
| Aug 18, 2025 | 0.9% Sodium Chloride Injection USP, 1000 mL container, Rx only, B. Braun Medi... | Presence of Particulate Matter. | Class I | B BRAUN MEDICAL INC |
| Aug 4, 2025 | Lactated Ringer's Injection USP, L 7500, 1000mL Excel Container, Rx Only, Ste... | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Class II | B BRAUN MEDICAL INC |
| Aug 4, 2025 | 0.9% Sodium Chloride Injection USP, L 8000, 1000mL Excel Container, Rx Only, ... | Lack of Assurance of Sterility; potential for fluid leakage at one of the weld sites. | Class II | B BRAUN MEDICAL INC |
| Jul 10, 2025 | Shave and Skincare Power Stick Original Nourishing Invisible Protection Roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Beauty & Skincare Power Stick original nourishing invisible protection roll-... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 10, 2025 | Power Stick for her PH Balanced Roll-On Antiperspirant Deodorant with Powder ... | CGMP Deviations | Class II | A.P. Deauville, LLC |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 4 mL, Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 2 mL., Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Fluorescein 2% Ophth, 3 ML, Boothwyn Pharmacy, 800-476-7496 | Subpotent Drug | Class III | Boothwyn Pharmacy LLC |
| Jul 9, 2025 | Semaglutide, 2.5 mg/mL injection, 0.8 mL, Boothwyn Pharmacy | Subpotent Drug | Class II | Boothwyn Pharmacy 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 10, 2025 | KIMMTRAK (tebentafusp-tebn) Injection, 100 mcg/0.5 mL, For intravenous Infusi... | Subpotent Drug | Class II | IMMUNOCORE, LLC |
| May 9, 2025 | Phentermine Hydrochloride Capsules, USP 30mg, 100-count bottle, Rx Only, Mfd.... | cGMP deviations | Class II | KVK Tech, Inc. |
| May 9, 2025 | Indomethacin Extended-Release Capsules USP, 75 mg, 100-count bottle, Rx only,... | cGMP deviations | Class II | KVK Tech, Inc. |
| Apr 22, 2025 | Clindamycin HCl Capsule, 300 mg, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations - products manufactured in a shared facility with Ezetimibe tablets. | Class II | RemedyRePack Inc. |
| Mar 24, 2025 | Clindamycin HCl, 300 mg Capsule, QTY: 30 Capsules per bottle, Rx Only, Repack... | CGMP Deviations | Class II | RemedyRepack Inc. |
| Feb 20, 2025 | PHENYLephrine added to 0.9% sodium chloride, 40 mg/250 mL* (160 mcg/mL), Rx O... | Presence of Particulate Matter | Class I | Central Admixture Pharmacy Services, Inc. |
| Jan 24, 2025 | Carvedilol 25 mg Tablet, QTY: 30 Tablets per Blister Pack (3 x 10 blister car... | CGMP deviations: presence of N-Nitroso Carvedilol Impurity-1 (NNC 1), above the FDA recommended a... | Class II | RemedyRepack Inc. |
| Jan 21, 2025 | Phenylephrine HCl Injection, USP 100 mg/10 mL (10 mg/mL) vials, Rx only, Phar... | Presence of Particulate Matter. | Class I | Provepharm Inc. |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 4 mg, 30 -count bottle, Rx on... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 23, 2024 | Cardura XL (doxazosin) extended release tablets 8 mg, 30-count bottle, Rx onl... | Failed Impurities/Degradation Specifications: Out of specification results observed for the impur... | Class II | Viatris Inc |
| Dec 2, 2024 | Duloxetine Delayed-Release Capsules, 60 mg, a) 30 count blister cards (NDC 70... | CGMP Deviations; presence of N-nitroso-duloxetine impurity above recommended interim limit. | Class II | RemedyRepack Inc. |
| Nov 22, 2024 | Dihydroergotamine Mesylate Injection, solution for injection, USP, 1 mg/mL Am... | Discoloration | Class II | Provepharm Inc. |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 25 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 75 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablets, USP, 0.25 mg, C-IV, Rx Only, 60 tab... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Clonazepam Orally Disintegrating Tablet, USP, 2 mg, C-IV, Rx Only, 60 Tablets... | Labeling: Label Error on Declared Strength; Some cartons were incorrectly labeled. The blister st... | Class I | Endo USA, Inc. |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 88 mcg, packaged in a) 90-count bottles (ND... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 137 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 175 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris Inc |
| Nov 18, 2024 | Levothyroxine Sodium Tablets USP, 112 mcg, packaged in a) 90-count bottles (N... | Superpotent Drug and Subpotent Drug: potency failures obtained | Class II | Viatris 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.