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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Dec 22, 2022 | PE1/PAPAV/ATROP/CHLOPROM** 7MCG/8.7MG/0.1MG/1.8MG/ML (1ML VIAL) INJECTABLE PE... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | PROGESTERONE-GS OIL- 100MG/ML (2ML VIAL) INJECTABLE, Rx Only, Pharmacy Innova... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | METHYLCOBALAMIN 12.5MG/ML (1ML VIAL) INJECTABLE METHYLCOBALAMIN 25MG/ML (1.2M... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | POLYHEXAMETHYLENE BIGUANIDE 0.2MG/ML (0.2%) (10ML DROPTAINER) OPTH SOLUTION, ... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | BSS Plus/Lidocaine Opth 1% (1ML syringe) Injectable, Rx Only, Pharmacy Innova... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | MAGNESIUM CHLORIDE HEXAHYDRATE-PF- 200MG/ML (5ML VIAL) INJECTABLE, Rx Only, P... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | 5-Fluorouracil 1%, 2.5ML droptainer, and 5ML droptainer Ophthalmic, Rx Only, ... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | Chlorpheniramine/Hyoscyamine (1ML) 10MG/0.25MG/ML Injectable, Rx Only, Pharma... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | Ethyl Alcohol 95% (5ML vial) Injectable, Rx Only, Pharmacy Innovations, 2936 ... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | LIDOCAINE-PF- 5% (5ML VIAL) INJECTABLE, Rx Only, Pharmacy Innovations, 2936 W... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | DEXAMETHASONE 16MG/ML (3ML VIAL) INJECTABLE; DEXAMETHASONE 24MG/ML INJECTABLE... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | PHOSPHATIDYLCHOLINE/DEOXYCHOLIC ACID (10ML VIAL) 50MG/50MG/ML (5%/5%) INJECTA... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 22, 2022 | GLYCERIN STERILE 99% 2ML VIAL and 5ML VIAL, Injectable, Rx Only, Pharmacy Inn... | Lack of Assurance of Sterility: FDA inspection revealed insanitary conditions at the facility. | Class II | Pharmacy Innovations |
| Dec 20, 2022 | Rifampin Capsules USP, 300 mg, 100 Capsules (10 x 10) per carton, Rx Only, Di... | Failed Impurities/Degradations Specifications | Class II | Amerisource Health Services LLC |
| Dec 20, 2022 | Rifampin Capsules, 300 mg, 30 count blister card, Rx only, Mfg: Lupin Pharma,... | Failed Impurities/Degradation specifications | Class II | RemedyRepack Inc. |
| Dec 16, 2022 | Ganciclovir for Injection, USP, 500mg per vial, packaged in a 10-count carton... | Labeling: Label mix-up - one vial was mislabeled as Cladribine Injection 10mg/mL inside a 10-coun... | Class II | Hikma Pharmaceuticals USA Inc. |
| Dec 16, 2022 | Glycopyrrolate Tablets, USP, 1 mg, 100 tablets, Rx Only, Distributed by: Auro... | Failed Impurities/Degradation Specifications | Class II | Aurolife Pharma, LLC |
| Dec 15, 2022 | Easy Clean Alcohol Mult Surface Disinfecting Cleaner 75% Ethyl Alcohol, 32 FL... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 m... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean 70% Isopropyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Global Care Antibacterial Hand Sanitizer Alcohol Etilico 70% Original, 1 Gall... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean Antiseptic Hand Sanitizer Solution 65% with Glycerine, 1 Gallon (1... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean Isopropyl Alcohol 99%, 1 Gallon (128 fl. oz.), Manufactured by: Fr... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 15, 2022 | Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 918... | cGMP Deviations | Class II | Frenda Corporation |
| Dec 12, 2022 | Menastil, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 g... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 12, 2022 | Rifampin Capsules USP, 300 mg, 30-count bottle; Rx Only, Manufactured for: Lu... | Failed Impurities/Degradation Specifications: Failure observed in related substance testing durin... | Class II | Lupin Pharmaceuticals Inc. |
| Dec 12, 2022 | Neuroquell, A Homeopathic Drug, Calendula Oil, packaged in1/8 Fl. oz. (3.5 g)... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 12, 2022 | ProSirona, A Homeopathic Formula, Calendula Oil packaged in 1/8 Fl. oz. (3.5 ... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 12, 2022 | Neuroquell Plus, Advanced Formula, A Homeopathic Drug, Calendula Oil packaged... | cGMP Deviations | Class II | Atlantic Management Resources Ltd. |
| Dec 9, 2022 | Alcohol Antiseptic 80% Topical Solution Hand Sanitizer, Non-Sterile Solution,... | CGMP Deviations: Impurities of acetal and acetaldehyde were discovered in the product in excess o... | Class II | NCH Life Sciences LLC |
| Dec 8, 2022 | Thiamine Hydrochloride 200 mg/2mL (100mg/mL), Riboflavin 2 mg/2mL (1mg/mL) In... | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Dec 8, 2022 | Thiamine Hydrochloride 3000 mg/30 mL (100mg/mL), Riboflavin 30 mg/30 mL (1mg/... | Presence of Particulate Matter: Presence of foreign substances were reported in vials at the phar... | Class II | McGuff Compounding Pharmacy Services, Inc. |
| Dec 7, 2022 | Quinapril Tablets USP, 40 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Class II | Lupin Pharmaceuticals Inc. |
| Dec 7, 2022 | Quinapril Tablets USP, 20 mg (90 pack), Rx Only, Manufactured for: Lupin Phar... | CGMP Deviations: Detection of N-Nitroso-quinapril impurity above the acceptable daily intake limit. | Class II | Lupin Pharmaceuticals Inc. |
| Dec 5, 2022 | Desmopressin Acetate Tablet, 0.2 mg, 100-count box, Rx only, Source NDC: 2315... | Subpotent Drug: repackaged product was recalled by the manufacturer for subpotency. | Class II | RemedyRepack Inc. |
| Dec 2, 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Fruit flavor, Chewable ... | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | Class II | GlaxoSmithKline Consumer Healthcare Holdings LLC |
| Dec 2, 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl... | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | Class II | GlaxoSmithKline Consumer Healthcare Holdings LLC |
| Dec 2, 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl... | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | Class II | GlaxoSmithKline Consumer Healthcare Holdings LLC |
| Dec 2, 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, Chewabl... | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | Class II | GlaxoSmithKline Consumer Healthcare Holdings LLC |
| Dec 2, 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Assorted Berries flavor, chewabl... | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | Class II | GlaxoSmithKline Consumer Healthcare Holdings LLC |
| Dec 2, 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tabl... | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | Class II | GlaxoSmithKline Consumer Healthcare Holdings LLC |
| Dec 2, 2022 | TUMS Antacid, Calcium Carbonate USP 1000 mg, Peppermint flavor, chewable tabl... | Presence of Foreign Substance: The foreign material is primarily comprised of glass mineral wool. | Class II | GlaxoSmithKline Consumer Healthcare Holdings LLC |
| Dec 1, 2022 | Oxcarbazepine Tablets 600mg, packaged in a) 100- count bottles (NDC 62756-185... | Presence of foreign substance | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Nov 29, 2022 | FentaNYL Citrate 2.5 mg/50 mL (50mcg/ml) Injection Solution, Preservative Fre... | Underfilled units. | Class II | OurPharma LLC |
| Nov 25, 2022 | 0.9% Sodium Chloride Injection USP 1000 mL Single-dose container Rx only NDC ... | Lack of sterility assurance: Bags have the potential to leak. | Class II | B. Braun Medical, Inc. |
| Nov 23, 2022 | Desmopressin Acetate Tablets 0.2mg, 100-count bottles, RX Only, Distributed b... | Subpotent Drug | Class II | Heritage Pharmaceuticals Inc |
| Nov 22, 2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Class II | Fresenius Kabi USA, LLC |
| Nov 22, 2022 | 0.9% Sodium Chloride Injection, USP, Each 100 mL contains: SODIUM CHLORIDE, U... | Lack of Assurance of Sterility: Leakage of 0.9% Sodium Chloride for Injection, 1L, 12pk Saline So... | Class II | Fresenius Medical Care Holdings, Inc. |
| Nov 22, 2022 | Sensorcaine-MPF (Bupivacaine HCl and Epinephrine Injection, USP) with Epineph... | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Class II | Fresenius Kabi USA, LLC |
| Nov 22, 2022 | Sensorcaine (Bupivacaine HCl and Epinephrine Injection, USP) with Epinephrine... | Subpotent Drug: Testing results below the defined limit for the epinephrine portion of this product. | Class II | Fresenius Kabi USA, 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.