Browse Drug Recalls
1,702 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,702 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 1,702 FDA drug recalls, Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | 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 | Allergy & Congestion Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Exte... | 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 Tablets U... | 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 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 | Antihistamine & Nasal Decongestant, Fexofenadine HCl 60 mg and Pseudoephedrin... | 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 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 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 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 | 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 | 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 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 | 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 | 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 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 | 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 |
| 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 |
| 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. |
| Jun 18, 2021 | B-Force, Homeopathic, 1 Fl Oz (30 mL) bottle, Distributed by: BioActive Nutri... | Superpotent | Class III | Grato Holdings, Inc. |
| Jun 9, 2021 | Phytonadione Tablets 5 mg, Rx Only, 30 Tablets (3x10) Unit Dose, Manufactured... | Failed Impurities Specification: Out of specification when measuring the impurity degradant D level. | Class III | AVKARE Inc. |
| Jun 8, 2021 | Ketamine HCl Injection Solution, 10 mg / 2 mL (5 mg/mL), Rx Only, Compounded ... | Labeling: Incorrect Exp. Date: Incorrect BUD. | Class III | Prisma Health Outsourcing Facility |
| Jun 8, 2021 | Mephyton (Phytonadione) 5 mg tablets, 100-count tablets, Rx Only, Manufacture... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, Inc. |
| Jun 8, 2021 | Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Ocean... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, Inc. |
| Jun 4, 2021 | Atorvastatin Calcium Tablets, USP 10 mg, 500-count bottles, Rx Only, Dr. Redd... | Failed Impurities/Degradation Specifications: due to presence of ATV cyclo IP and FP impurities | Class III | Dr. Reddy's Laboratories, Inc. |
| May 26, 2021 | Levetiracetam Tablets USP, 250 mg UD 100 Tablets (10x10) boxes, Rx Only, Dist... | Labeling; Wrong Barcode; error in the machine-readable barcode which could result in some units b... | Class III | McKesson Corporation dba McKesson Drug Company |
| May 14, 2021 | READYPREP CHG, 2% Chlorhexidine Gluconate Cloth, 2 9x10.5 in (22.9x26.7 cm) D... | Superpotent Drug: Product is above specification for active ingredient, 2% Chlorhexidine Gluconate. | Class III | Medline Industries 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.