Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
Mar 11, 2021 ZOMA-Jet 5 Demonstration Kit, Needle-free delivery device for use with ZOMACT... Defective Delivery System: customer complaints concerning the injector pen breaking apart and dis... Class II Ferring Pharmaceuticals Inc
Mar 11, 2021 Phenylephrine HCl Injection, USP, 10 mg per mL, 1 mL per Single-Dose Vial pac... Lack of Assurance of Sterility: customer complaints of loose crimped vial overseals which may res... Class II Sagent Pharmaceuticals Inc
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizing Wipes... CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the sa... Class II Sanit Technologies, LLC dba Durisan
Mar 10, 2021 aulief (Organic Camphor 3.00% Organic Menthol 5.00%), topical pain relief, pa... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 CHINA_GEL (Camphor 3.00%, Menthol 5.00%) A TOPICAL PAIN RELIEVER, packaged as... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 10, 2021 Durisan Antimicrobial Solutions (benzalkonium chloride) Hand Sanitizer, liste... CGMP Deviations: lots recalled due to CGMP deviations because they were manufactured under the sa... Class II Sanit Technologies, LLC dba Durisan
Mar 10, 2021 CHINA-GEL WHITE (Camphor 3.00%, Menthol 5.00%), A TOPICAL PAIN RELIEVER, pack... CGMP deviations: Product being recalled as it was made in the same facility where contamination w... Class II China Gel Inc
Mar 9, 2021 0.9% SODIUM CHLORIDE Irrigation, USP 1000 mL Semi-Rigid Bottle, Rx only, Manu... Presence of particulate matter.one confirmed customer report of particulate matter within two se... Class II ICU Medical Inc
Mar 8, 2021 Gabapentin Oral Solution, 250 mg/5 mL, 5 mL per unit dose cup, four unit dose... Failed Impurities/Degradation Specifications; out of specification for unknown impurity observed ... Class II Akorn, Inc.
Mar 2, 2021 Nortriptyline HCL capsules, 10 mg, packaged in 30-count bottles, Rx only, Pac... cGMP deviations: The quantity of active ingredient used for the product lot was inadvertently tak... Class II Direct Rx
Feb 26, 2021 Progesterone Capsules, 200 mg, 100-count bottles, Rx Only, MADE IN FRANCE; Di... Failed Dissolution Specifications: Out-of-specification results observed for dissolution during s... Class II Dr. Reddy's Laboratories, Inc.
Feb 26, 2021 Buprenorphine and Naloxone Sublingual Film 2mg/0.5mg, 30 pouches each contain... Subpotent drug: Out of specification for assay of naloxone and buprenorphine (low) Class II Alvogen, Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system), Delivers 15 mg over 9 hours (1... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system), Delivers 10 mg over 9 hours (1... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 19, 2021 Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.... Defective Delivery System: Out of specification for mechanical peel. Class II Noven Pharmaceuticals Inc
Feb 17, 2021 Fludeoxyglucose F 18 Injection, 20-300 mCi/mL at End of Synthesis (EOS) Solut... Lack of Assurance of Sterility Class II The General Hospital Corporation
Feb 17, 2021 Imatinib Mesylate Tablets 100mg, packaged as a) 90-count bottles (NDC 43598-3... Failed Dissolution Specifications Class II Dr. Reddy's Laboratories, Inc.
Feb 15, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 25x2mL Single Dose Vials,... Chemical contamination; Unknown brown residue adhering to the inside of one vial. Class II Teva Pharmaceuticals USA
Feb 10, 2021 Toposar (etoposide injection USP), 1 gram/50 mL (20 mg/mL), 50 mL Multiple-do... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 80 mg/mL, 1 mL Single-D... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 40 mg/mL, 1 mL Single... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Vecuronium Bromide for Injection, 10 mg, 1 mg/mL when reconstituted to 10 mL,... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Dacarbazine for Injection USP, 200 mg, Single Use Vial (NDC 0703-5075-01), pa... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Epoprostenol Sodium for Injection, 1.5 mg/vial (1,500,000 ng), 10 mL vial, Rx... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Metoclopramide Injection USP, 10 mg/2 mL (5 mg/mL), 2 mL Single-Use Vial NDC ... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Sterile Diluent for Epoprostenol Sodium for Injection, 50 mL vial (NDC 0703-9... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Desmopressin Acetate Injection USP, 4 mcg/mL, 1 mL Preserved Vial (NDC 0703-5... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Epoprostenol Sodium for Injection, 0.5 mg/vial (500,000 ng), 1X10ML vial, Rx... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/5 mL (80 mg/mL),... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 400 mg/10 mL (40 mg/mL)... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Leucovorin Calcium for Injection, USP, 350 mg/vial, Rx only, labeled as a) Te... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 Leucovorin Calcium for Injection, USP, 100 mg/vial, Single-Dose Vial, Rx only... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 10, 2021 MethyIPREDNISolone Acetate Injectable Suspension USP, 200 mg/5 mL (0 mg/mL), ... Lack of Assurance of Sterility: manufacturing areas for the recalled products exceeded acceptance... Class II Teva Pharmaceuticals USA
Feb 4, 2021 Meclizine HCl Tablets, USP, 25 mg, 100 Tablets bottles, Rx Only, Mfd. for: Wi... Failed Dissolution Specifications Class II Wilshire Pharmaceuticals Inc
Feb 4, 2021 Meclizine HCl Tablets, USP, 12.5 mg, 100 Tablets bottles, Rx Only, Mfd. for: ... Failed Dissolution Specifications Class II Wilshire Pharmaceuticals Inc
Feb 1, 2021 Scott¿ Moisturizing Foam Hand Sanitizer, 1.2 Liters (40.5 fl oz), Distributed... Labeling; Label Mix-up; some bottles containing Foam Skin Cleanser soap are incorrectly labeled a... Class II Kimberly-Clark Corporation
Jan 27, 2021 Spironolactone Tablets, USP, 50 mg, packaged in 30-count bottles, Rx only, Ma... Labeling: Label Mix-Up - Prepackaged bottles labeled spironolactone 50 mg may contain spironolact... Class II Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Jan 25, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 Tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Jan 22, 2021 Cephalexin for Oral Suspension, USP 250 mg per 5 mL 200 ml (when mixed) Rx On... CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... Class II Ascend Laboratories LLC
Jan 22, 2021 Cephalexin for Oral Suspension, USP 250 mg per 5 mL, 100 ml (when mixed) Rx O... CGMP Deviations: Individual Unidentified impurities results of the product was found at higher si... Class II Ascend Laboratories LLC
Jan 21, 2021 Lidocaine/Tetracaine (LIPO110)* 23%/7% Ointment 100 GMS per 4 ounce plastic o... Superpotent Drug. Lidocaine higher concentration than listed Class II Stanley Specialty Pharmacy Compounding and Well...
Jan 20, 2021 Famotidine Tablets USP 40mg, 1,000-count bottles, Rx only, Distributed by: Au... Presence of foreign tablets/capsules: Famotidine 20mg and ibuprofen 400mg tablets were found in a... Class II Aurobindo Pharma USA Inc.
Jan 8, 2021 Nortriptyline HCl Capsules, USP equivalent to 10mg base Mfd. by: Taro Pharmac... CGMP deviations. Class II Taro Pharmaceuticals U.S.A., Inc.
Jan 7, 2021 Nitrofurantoin Capsules USP (Monohydrate/Macrocrystals), 100 mg, 100 per cart... Failed Dissolution Specifications Class II American Health Packaging
Jan 6, 2021 Sulfur Ointment 10%, Pomada de Azufre, 2.6 OZ (73.7g) jar; Manufactured by/ F... Labeling: Label Mix-Up. THe English label with Drug Facts panel for Camphor was incorrectly place... Class II DLC Laboratories, Inc
Jan 4, 2021 Metformin Hydrochloride Extended-Release Tablets, USP, 750 mg, 100 tablets pe... CGMP Deviations: detection of N-Nitrosodimethylamine (NDMA) impurity above the acceptable intake ... Class II Nostrum Laboratories Inc
Jan 1, 2021 Chlorhexidine Gluconate Oral Rinse USP 0.12%, packaged in a) 15 mL x 30 Unit ... cGMP deviations: The firm was notified of the manufacturer's expanded recall. Class II Precision Dose Inc.
Dec 30, 2020 Acetaminophen Injection 1,000 mg per 100 mL (10 mg/mL), 100 mL Single Dose Vi... Discoloration and failed pH specifications Class II AuroMedics Pharma LLC
Dec 30, 2020 Refresh Relieva PF Preservative-Free Lubricant Eye Drops 0.33 fl oz (10 mL) S... Labeling: Missing instructions for use insert Class II Allergan, PLC.

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.