Browse Drug Recalls

14,449 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,449 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 14,449 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Jun 23, 2022 MUCINEX FASTMAX CAPLETS COLD FLU 4CT distributed to specific Family Dollar St... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DULCOLAX 5 MG TABLET 25 CT distributed to specific Family Dollar Stores 04/30... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 FS HYDROCORTISONE CREAM 1 OZ SKU 910321 CORTIZONE 10 CREME 0.5 OZ SKU 910167... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 MUCINEX SE MAX STRENGTH 7CT distributed to specific Family Dollar Stores 04/3... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 21, 2022 Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... cGMP - Water leakage Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 16, 2022 Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregat... Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. Class II Jubilant Draximage Inc
Jun 16, 2022 Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufa... Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. Class II Macleods Pharma Usa Inc
Jun 15, 2022 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in ... Defective Container: Product may leak when squeezed or when not in an upright position determined... Class II Vi-Jon, LLC
Jun 14, 2022 Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuti... Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. Class II Teva Pharmaceuticals USA Inc
Jun 13, 2022 Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amb... Defective container: defect prevents product from dispensing as intended. Class II Akorn, Inc.
Jun 10, 2022 Calcipotriene Topical Solution, 0.005% (Scalp Solution), Rx only, 60 mL (2 fl... Defective Delivery System: Potential defect that could prevent the product from dispensing as int... Class II Akorn, Inc.
Jun 10, 2022 Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial exc... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 10, 2022 Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 10, 2022 Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 10, 2022 Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... Failed Dissolution Specifications: Out of specification test results observed in dissolution test... Class II Lupin Pharmaceuticals Inc.
Jun 10, 2022 Bethanechol Chloride 1mg/ml, 80 ml Suspension bottles Banana/Strawberry, Qty:... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 10, 2022 Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 mg, 30, 90 & 1000 ... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II Macleods Pharma Usa Inc
Jun 10, 2022 Boric Acid 600 mg capsules, 14 capsules per box, Qty: 1, Wedgewood Village Ph... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 10, 2022 Boric Acid 600 mg per suppository, 14 Vaginal Suppositories per box, Wedgewo... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 10, 2022 Estriol 1mg/gm, Vaginal Cream, 30 gm tube, Qty: 1, Wedgewood Village Pharmac... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 9, 2022 Clonidine Transdermal System, USP 0.3 mg/day, 4 Patches (NDC 51862-455-01) pe... Defective Delivery System: Out of specification for release liner removal force results at the 3... Class II Mayne Pharma Inc
Jun 7, 2022 CORRECTDOSE Children's ALLERGY RELIEF (Diphenhydramine HCl 12.5 mg per 5 mL),... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Diphenhydramine HCl Oral Solution 12.5 mg / 5 mL, 5 mL cup, packaged in 10 cu... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Diphenhydramine HCl Oral Solution, 25 mg / 10 mL, 10 mL cup, packaged in 10 c... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 1200 mg, Aluminum Hydroxide 1200 mg, Simethicone 120 mg p... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/10 mL, Magnesium Hydroxide, 30 mL cup, packaged... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CALCIUM CARBONATE ORAL SUSPENSION, 1250 mg/5 mL, 5 mL cup, packaged in 10 cup... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution 160 mg / 5 mL, 5 mL cup, packaged in 10 cups per ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution 650 mg / 20.3 mL, 20.3 mL cup, packaged in 10 cup... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CORRECTDOSE Children's PAIN RELIEF & Fever Reducer, Cherry, (Acetaminophen 1... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Magnesium Hydroxide 2400 mg, Aluminum Hydroxide 2400 mg, Simethicone 240 mg M... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 Acetaminophen Oral Solution, 325 mg / 10.15 mL, 10.15 mL cup, packaged in 10 ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 MILK OF MAGNESIA USP, 2400 mg/30 mL, Magnesium Hydroxide, 30 mL cup, packaged... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 CORRECTDOSE Children's COUGH & CHEST CONGESTION DM (Guaifenesin 100 mg / Dext... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 100 mg-10 mg/5 mL, 5 mL cup, packaged in 10 ... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 7, 2022 GUAIFENESIN AND DEXTROMETHORPHAN 200-20 mg/10 mL, 10 mL cup, packaged in 10 c... CGMP Deviations: products manufactured under conditions which reflect manufacturing processes tha... Class II Plastikon Healthcare LLC
Jun 6, 2022 Losartan Potassium Tablets, USP 25 mg, 90 Tablets bottles, Rx Only Marketed a... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 6, 2022 Losartan Potassium Tablets, USP 50 mg, 90 Tablets bottles, Rx Only Marketed a... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 6, 2022 Losartan Potassium Tablets, USP 100 mg, 90 Tablets bottles, Rx Only, Marketed... CGMP Deviations- AZIDO Impurity levels observed to be above acceptable limits Class II PD-Rx Pharmaceuticals, Inc.
Jun 3, 2022 Testosterone Cypionate Injection, USP, 200mg/ml, Rx Only, One Single-dose via... CGMP Deviations: Manufacturing deviations were reported due to an abnormal appearance on parts of... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 3, 2022 Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... CGMP Deviations: lots made with same active pharmaceutical ingredient (API) as lots that were rej... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 3, 2022 Clonazepam Orally Disintegrating Tablets, USP, 0.125mg, Rx Only, 60 Tablets, ... Failed Tablet/Capsule Specification; oversized tablet found in a bottle Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 24, 2022 Ethanol for Injection 95%, 67 mL Multi-Dose vial, Rx only, US Specialty Formu... Lack of Assurance of Sterility Class II US Specialty Formulations LLC
May 24, 2022 Earache Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: Walgreen Co., 200 ... Microbial contamination of non-sterile product. Class II Grato Holdings, Inc.
May 24, 2022 B-Complex + Chromic Chloride (Choline Chloride 3%, Inositol 3%, Pyridoxine HC... Lack of Assurance of Sterility Class II US Specialty Formulations LLC
May 24, 2022 Artri Ajo King Reforzado con Ortiga y Omega 3 Tablets, ORIGINAL, 100-count bo... Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... Class II Walmart Inc
May 24, 2022 Artri King Reforzado con Ortiga Omega 3 Tablets, ORIGINAL, a) 100-count bottl... Marketed Without An Unapproved NDA/ANDA: All lots were found to be unapproved drugs based on labe... Class II Walmart Inc
May 24, 2022 Homeopathic EarAche Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: RITE A... Microbial contamination of non-sterile product. Class II Grato Holdings, Inc.
May 24, 2022 Homeopathic EarAche Ear Drops, 0.33 FL OZ (10 mL) bottles, Distributed by: CV... Microbial contamination of non-sterile product. Class II Grato Holdings, Inc.
May 18, 2022 Rocuronium Bromide Injection, 50 mg/5 mL (10 mg/mL), Preservative Free, 5 mL ... Lack of Assurance of Sterility Class II Nephron Sterile Compounding Center LLC

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.