Browse Drug Recalls
1,680 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,680 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 1,680 FDA drug recalls — Class III.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 12, 2021 | Loratadine-D Extended-Release Tablets (Loratadine and Pseudoephedrine Sulfate... | Failed Moisture Limits | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Oct 12, 2021 | AllerClear D-24 hr, (Loratadine and Pseudoephedrine Sulfate, Extended-Release... | 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 | 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. |
| 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 |
| 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 | Phytonadione Tablets, 5 mg, 30-count ablets, Rx only, Manufactured for: Ocean... | Failed Impurities/Degradation Specifications | Class III | Bausch Health Companies, Inc. |
| 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 | 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 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 |
| May 12, 2021 | Sirolimus Tablets 1 mg, 30 Tablets (5 blister cards x 6 unit doses), Rx only,... | Failed Impurities/Degradation Specifications | Class III | American Health Packaging |
| May 7, 2021 | Cequa (cyclosporine ophthalmic solution) 0.09%, 60 Single-Use Vials (6 pouche... | Subpotent and Presence of Particulates . | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| May 4, 2021 | Atorvastatin Calcium Tablets, USP 10 mg*, Rx Only, 500 count bottle, Mfd By: ... | Failed Impurities -Degradation Specifications:due to presence of ATV cyclo IP and FP impurities | Class III | Dr. Reddy's Laboratories, Inc. |
| May 3, 2021 | Thiamine HCl Injection, USP 200 mg/2 mL (100mg/mL), 2 mL vials, packaged in 2... | Labeling: Incorrect or Missing Lot and/or Exp Date: Cartons with the correct lot number 200906 co... | Class III | Mylan Institutional LLC |
| Apr 29, 2021 | Olmesartan Medoxomil Tablets, USP, 20 mg, Rx Only, 30 Tablets, Manufactured b... | Presence of Foreign Tablet/Capsule | Class III | Ascend Laboratories LLC |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, 5000 mL bags, 2-pack... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 1.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 2.5 % Dextrose, Low Magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFELX Peritoneal Dialysis Solution with 4.25% Dextrose, Low Magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 4.25% Dextrose, Low magnesium, Low ... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 28, 2021 | DELFLEX Peritoneal Dialysis Solution with 2.5% Dextrose, Low magnesium, Low C... | Temperature Abuse: Product exposed to temperature outside specified limits. | Class III | Fresenius Medical Care Holdings, Inc. |
| Apr 27, 2021 | Hydrocodone Bitartrate and Homatropine Methlybromide tablets, USP, 5 mg/ 1.5 ... | Failed Impurities/Degradation Specifications | Class III | KVK-Tech, Inc. |
| Apr 21, 2021 | Acyclovir Tablets, USP, 400 mg, 100 Tablets, Rx Only, Distributed by: Avet Ph... | Labeling: Incorrect or Missing Lot and/or Exp Date | Class III | Heritage Pharmaceuticals Inc |
| Apr 20, 2021 | Evrysdi (risdiplam) for oral solution, 60 mg/80mL (0.75mg/mL), 80 mL total vo... | Defective Container: complaints received regarding some incorrect press-in-bottle-adapters (PIBA)... | Class III | Genentech Inc |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 10 mg, Rx only, 60 Tablets, Sigmapharm Laborato... | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... | Class III | SigmaPharm Laboratories LLC |
| Apr 19, 2021 | Asenapine Sublingual Tablets, 5 mg, Rx Only, 60 Tablets, Sigmapharm Laborator... | Incorrect Product Formulation; product was manufactured with the incorrect Art Cherry Flavor flav... | Class III | SigmaPharm Laboratories LLC |
| Apr 13, 2021 | Dry Eye Test, Fluorescein Sodium, Ophthalmic Strips USP (0.12mg Fluorescein S... | Subpotent Drug | Class III | Nomax Inc |
| Mar 29, 2021 | Lidocaine Ointment USP, 5%, NET WT 35.44 g (1 1/4 Oz) tube, Rx Only, Teligent... | Failed Stability Specifications: product did not meet viscosity results. | Class III | Teligent Pharma, Inc. |
| Mar 25, 2021 | Metformin HCl Extended-Release Tablets, USP, 500 mg, Rx Only, 500-count bottl... | Failed Moisture Limits: Out of specification for water content | Class III | SUN PHARMACEUTICAL INDUSTRIES INC |
| Mar 22, 2021 | Candesartan Cilexetil Tablets, USP, 4 mg, 30-count bottles, Rx only, Manufact... | Failed Impurities/Degradation Specifications | Class III | Macleods Pharma Usa Inc |
| Mar 19, 2021 | Distributed by: DocRx, Methylprednisolone Tablets, USP 4 mg, Rx, 21 Count Bli... | Labeling: Illegible label: Manufacturer received complaint of mis-alignment print of the printed ... | Class III | Asclemed USA Inc. dba Enovachem Pharmaceuticals |
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.