Browse Drug Recalls
788 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 788 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 788 FDA drug recalls in WA.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Jul 18, 2025 | Tirzepatide + Niacinamide 13.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 u... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 8.8 mg + 1.0mg/0.5 ml Inj Sol, Inject 0.5 mL (50 u... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 2.67 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 6.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 u... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 16.6 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 ... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 0.44 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL ... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 11.24 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 2.2 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 un... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 0.22 mg + 0.25mg/0.5 ml Inj Sol, Inject 0.5 mL (... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Tirzepatide + Niacinamide 4.4 mg + 1.0mg/0.5 mL Inj Sol, Inject 0.5 mL (50 un... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin 0.88 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide + Cyanocobalamin injection solution, 2.21 mg + 0.25mg/0.5 mL Inj ... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jul 18, 2025 | Semaglutide +Cyanocobalamin 1.5 mg + 0.25mg/0.5 mL Inj Sol, Inject 0.5 mL (50... | Lack of Processing Controls. | Class II | AEQUITA PHARMACY |
| Jun 6, 2023 | GLYCOPYRROLATE INJECTION, USP 0.2MG/ML, 1mL VIAL, manufactured by HF Acquisit... | Labeling: Label Mix-up | Class III | HF Acquisition Co LLC |
| Feb 14, 2023 | Snowy Range Blue Alcohol Antiseptic 80% Topical Solution Hand Sanitizer Non-S... | Chemical Contamination: FDA analysis found the product to contain methanol, acetaldehyde, and ace... | Class I | Nanomaterials Discovery Corporation |
| May 26, 2022 | Artri King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bottle, ... | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... | Class I | Amazon.com, Inc. |
| May 26, 2022 | Ortiga mas Ajo Rey Reforzado con Omega 3, 6 y 9, is packaged in a carton cont... | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... | Class I | Amazon.com, Inc. |
| May 26, 2022 | Artri Ajo King Reforzado con Ortiga y Omega 3 tablets, 500 mg, 100-count bott... | Marketed Without An Approved NDA/ANDA: FDA laboratory analysis found the product to contain undec... | Class I | Amazon.com, Inc. |
| 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 17, 2020 | Famotidine Injection, USP, 20 mg/2mL, 2 mL vial, Rx only, Single Dose Vial, F... | TEMPERATURE ABUSE: Complaint received from customer that product was received in a non-refrigerat... | Class III | HF Acquisition Co. LLC |
| Jun 12, 2020 | Koala Hand Sanitizer, Unscented, 16 FL OZ., Antibacterial, (Ethyl Alcohol 70... | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... | Class II | Beaming White Llc |
| Jun 12, 2020 | Koala Hand Sanitizer, Menthol, 16 FL OZ., Antibacterial, (Ethyl Alcohol 69%)... | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... | Class II | Beaming White Llc |
| Jun 12, 2020 | Koala Hand Sanitizer, Soothing Eucalyptus, 16 FL OZ., Antibacterial, (Ethyl ... | Subpotent Drug: active ingredient ethanol tested below label claim and there is presence of undec... | Class II | Beaming White Llc |
| May 11, 2020 | Sterile Cannabidiol (CBD) 50mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Cannabidiol (CBD) 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Curcumin, 4mg/mL, 10mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| May 11, 2020 | Sterile Cannabidiol (CBD) + Curcumin 50mg/mL, 10 mL vial | Lack of Assurance of Sterility and Marketed without an approved NDA/ANDA: Product contains unappr... | Class II | BIOTA Biosciences LLC |
| Jun 26, 2019 | Hydroxocobalamin 10 mg/mL Injection (ALT) Solution, 30 mL vial, Rx only, Firs... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Hydroxyprogesterone Caproate 250 mg/mL Sesame Oil Injection, 5 mL vial, Rx on... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Methylcobalamin 1 mg/mL Injection, 8 mL vial, Rx only, First Pharma Associat... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Chorionic Gonadotropin 2,000U/mL PF Injection, 8 mL vial, Rx only, First Phar... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 200 mg/mL Ethyl Oleate Injection, packaged in a) 7.2 m... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Serum Tears 20% Eye Drops PF Solution, packaged in a) 15 EA, b)15 mL vials, c... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 18 mg/0.6mg/5.88mcg/mL Injection, 5 mL vial, Rx only, First Pha... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 30 mg/2mg/20mcg/mL Injection, 10mL vial, Rx only, First Pharma... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 100 mg/mL Sesame Oil Injection, 12mL vial, Rx only, F... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cyp/Estradiol Cyp 50 mg/2.5 mg/mL Injection, 3mL vial, Rx only, ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Glutathione 100 mg/mL Inhalation Solution (PF), 45 mL vial, Rx only, First P... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 30 mg/0.83mg/10mcg/mL Injection, 5 mL, Rx only, First Pharma As... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 150 mg/mL Sesame Oil Injection, 12 mL vial, Rx only, ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 200 mg/mL Sesame Oil Injection, packaged in a) 9 mL, b... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Testosterone Cypionate 100 mg/mLOil Injection Injection, 12 mL vial, Rx only,... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Methylcobalamin 10 mg/mL Injection, 5.4 mL vial, Rx only, First Pharma Assoc... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | Prostaglandin 20 mcg/mL/Procaine 0.1% Injection, packaged in a) 2.5mL and b)1... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Jun 26, 2019 | PAP/PHEN/PGE1 22 mg/0.8mg/8mcg/mL Injection, 5mL vial, Rx only, First Pharma ... | Lack of Assurance of Sterility. | Class II | First Pharma Associates LLC dba Riverpoint Phar... |
| Apr 18, 2017 | SODIUM CHLORIDE INH PF GV 0.9% SOLN, Inhalation Solution, 0.90%, Rx only, 5mL... | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... | Class II | Key Pharmacy and Compounding Center |
| Apr 18, 2017 | VIT C/GSH 1.25%-1.25% OPHTH, Ophthalmic, 1.25%, Rx only, 15 mL Plastic/ Multi... | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... | Class II | Key Pharmacy and Compounding Center |
| Apr 18, 2017 | PGE1 5ML MDV INJ, Injection, 40mcg/mL, Rx only, 5mL glass/Multiple Dose vial... | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... | Class II | Key Pharmacy and Compounding Center |
| Apr 18, 2017 | TRI MIX 6/18/0.6 5ML MDV MCG/MG/MG/ML INJ, Injection, 6mcg/18mg/0.6mg/mL, Rx ... | Lack of Assurance of Sterility: The firm is recalling sterile compounded drugs within expiry due ... | Class II | Key Pharmacy and Compounding Center |
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.