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.

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DateProductReasonClassFirm
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.