Browse Drug Recalls

1,710 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,710 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 1,710 FDA drug recalls, Class III.

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DateProductReasonClassFirm
Dec 3, 2021 CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodiu... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 Oxycodone Hydrochloride Oral Solution, USP 5 mg per 5 mL (1 mg/mL), 500 mL bo... Labeling: Missing Label Class III Akorn, Inc.
Dec 3, 2021 CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodi... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neut... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 3, 2021 CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only... Subpotent Drug: Product contains less Sodium Fluoride than listed on product label. Class III Dental Alliance Holdings LLC
Dec 1, 2021 Telmisartan and Hydrochlorothiazide Tablets, USP, 40 mg/12.5 mg, 30 count bot... Superpotent; Hydrochlorothiazide Class III Torrent Pharma Inc.
Nov 19, 2021 Tydemy (drospirenone, ethinyl estradiol & levomefolate calcium tablets, 3 mg/... Subpotent Drug Class III Lupin Pharmaceuticals Inc.
Nov 15, 2021 Carvedilol Tablets, USP, 6.25 mg, 500 Tablets bottle, Rx Only, Distributed by... Failed Impurities/Degradation Specifications Class III Aurobindo Pharma USA Inc.
Nov 12, 2021 Allergy & Congestion Relief Allergy Relief D, Fexofenadine HCl 60 mg/ Pseudoe... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Fexofenadine HCl, 60 mg & Pseudoephedrine HCl 120 mg, Extended Release Tablet... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 12 HR Allergy & Congestion Relief Fexofenadine HCl, 60 mg I Pseudoephedrine H... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Fexofenadine HCl 60 mg/ Pseudoephedrine HCl 120 mg Extended Release Tablets U... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Nov 12, 2021 Allergy Relief D Fexofenadine HCl, 60 mg I Pseudoephedrine HCl, 120 mg, Exten... Failed dissolution specifications Class III Dr. Reddy's Laboratories, Inc.
Oct 28, 2021 Clonidine Transdermal System, USP 0.1 mg/day, 4 patches per carton, Rx only, ... Failed Impurities/Degradation Specifications Class III Teva Pharmaceuticals USA
Oct 25, 2021 Topiramate Tablets, USP 50 mg, 500-count bottles, Rx Only, Manufactured by: U... Discoloration Class III UNICHEM PHARMACEUTICALS USA INC
Oct 20, 2021 Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured ... Failed Stability Specifications: Out-of-specification results observed in a water loss test that ... Class III Lupin Pharmaceuticals Inc.
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 10mg, 18 Tablets (3 x 6 Un... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 18, 2021 Rizatriptan Benzoate Orally Disintegrating Tablets 5mg, 12 Tablets (2 x 6 Uni... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 18, 2021 Rizatriptan Benzoate Film Coated Tablets, 10 mg, packaged in a) 12 Tablets (2... Out-of-specification test results obtained in Organic Impurities test during analysis of controll... Class III MACLEODS PHARMA USA, INC
Oct 13, 2021 PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 ... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 6... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 ZEE+ painaid ESF Extra-Strength Formula (Acetaminophen 250 mg, Aspirin 250 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) t... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 13, 2021 Vica-Cet BACK PAIN RELIEF (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg... Failed Stability Specifications: Out-of-Specification results observed for Aspirin related compou... Class III Ultra Seal Corporation
Oct 12, 2021 AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release... Failed Moisture Limits Class III SUN PHARMACEUTICAL INDUSTRIES INC
Oct 12, 2021 Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate... Failed Moisture Limits Class III SUN PHARMACEUTICAL INDUSTRIES INC
Oct 5, 2021 Cetirizine hydrochloride, 10 mg tablets, 90-count bottle, Distributed by: A-S... Labeling: Not Elsewhere classified: Product was relabeled as 90 tablet count product although it ... Class III A-S Medication Solutions LLC.
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablets, packaged in a) 12-count bottles, NDC... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 28, 2021 Butalbital, APAP, Caf 50/325/40 Tablet, packaged in a) 12-count bottles, NDC:... Labeling: Not Elsewhere Classified: the controlled substance classification "CIII" is missing on ... Class III Bryant Ranch Prepack, Inc. dba BRP Pharmaceuticals
Sep 13, 2021 Candesartan Cilexetil Tablets, USP 16 mg, 30 count bottles, Manufactured for:... Failed Impurities/Degradation Specifications; out of specification for Related Compound Class III Viatris
Sep 3, 2021 Glycopyrrolate Injection, USP 4mg per 20mL, 20 mL Multi-Dose Vials, Rx only, ... Failed Impurities/Degradation Specifications Class III Meitheal Pharmaceuticals Inc
Sep 2, 2021 Daytime Severe Cold & Flu Relief 8 Pre-Measured Vials 0.51 FL OZ (15 mL) Each... Subpotent Drug Class III New Vision Pharmaceuticals LLC
Sep 2, 2021 CVS Health Daytime Severe Cold & Flu Relief Single-Use Vials Mixed Berry Flav... Subpotent Drug Class III New Vision Pharmaceuticals LLC
Sep 1, 2021 Hydroquinone, USP, 4% Skin Bleaching Cream, packaged in 1 oz (28.35g) tube, R... Subpotency: one product for active ingredient assay and another one for preservative assay Class III Monarch PCM, LLC
Sep 1, 2021 Sodium Sulfacetamide, 10%, Wash, packaged in bottles: a) 6 fl oz (177 mL) NDC... Subpotency: one product for active ingredient assay and another one for preservative assay Class III Monarch PCM, LLC
Aug 20, 2021 Donepezil HCL Tablets, USP, 5 mg, 90-count bottle, Rx only, Manufactured by: ... Subpotent Class III Jubilant Cadista Pharmaceuticals, Inc.
Aug 5, 2021 Avicel, Mirocrystalline cellulose, packaged in bulk as PH101 NF, PH102 NF, PH... Out of specification results for conductivity. Class III DuPont Nutrition USA, Inc
Aug 5, 2021 Bleomycin for Injection, USP, packaged in 15 units per single dose vial, Rx o... Labeling: Not elsewhere classified: Mislabeling Class III Hikma Pharmaceuticals USA Inc.
Jul 29, 2021 Lidocaine Ointment USP, 5% Rx Only, Net Wt 35.44 g(1 1/4 oz)packaged in a lam... Failed Viscosity Specifications: lot does not meet specification for Viscosity, which was determi... Class III Teligent Pharma, Inc.
Jul 7, 2021 Acetaminophen EXTRA STRENGTH Pain Reliever / Fever Reducer, Enteric Coated, 5... Labeling: Not Elsewhere Classified The primary label contains the words "enteric coated" but the ... Class III LNK International, 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 22, 2021 Erythromycin Topical Solution USP, 2% 60 mL, Rx Only, Teligent Pharma, Inc., ... Failed Impurities/Degradation Specifications Class III Teligent Pharma, Inc.
Jun 22, 2021 Erythromycin Topical Gel, 2%, Net Wt. (a) 30 g,(NDC 52565-033-30) (b) 60 g,(N... Failed Impurities/Degradation Specifications Class III Teligent Pharma, 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.