Browse Drug Recalls
14,449 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 14,449 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 14,449 FDA drug recalls, Class II.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 10, 2022 | PF-Neostigmine Methylsulfate Injection, USP, 3 mg/3 mL (1 mg/mL), One 3 mL Un... | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Class II | Nephron Sterile Compounding Center LLC |
| Aug 10, 2022 | Colgate Whitening Mouthwash, OPTIC WHITE ICY FRESH MINT. 16 fl. OZ. (1 pt) 47... | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Class II | Family Dollar Stores, Llc. |
| Aug 8, 2022 | Corsair Personal Care 99X Instant Foam Hand Sanitizer (benzalkonium chloride ... | CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. | Class II | Midlab Incorporated |
| Aug 8, 2022 | Maxim Instant Foam Hand Sanitizer (benzalkonium chloride 0.1%) packaged in a)... | CGMP Deviations: Product manufactured using expired active ingredient, Benzalkonium chloride. | Class II | Midlab Incorporated |
| Aug 4, 2022 | Acetaminophen Injection, 10 mg/mL, 1,000 mg/100 mL, 100 mL VIAFLO container b... | Temperature Abuse: Product distributed in refrigerated trucks with labels attached to pallets ind... | Class II | Baxter Healthcare Corporation |
| Aug 2, 2022 | Difluprednate Ophthalmic Emulsion 0.05%, For Ophthalmic Use Only, Sterile, 5 ... | Lack of Assurance of Sterility: Complaints received of defective container closure. | Class II | CIPLA |
| Aug 1, 2022 | PrednisoLONE Oral Solution USP, 15 mg per 5 mL, 240 ml bottle, Rx Only, HI-TE... | Defective Container: Product has incomplete induction seals. | Class II | Akorn, Inc |
| Jul 28, 2022 | Rifampin Capsules, USP, 150 mg, 30 count HDPE bottles, Rx Only, Manufactured ... | CGMP Deviations:OOS result was observed in 1-Methyl-4-Nitroso Piperazine (MNP) impurity. | Class II | Lupin Pharmaceuticals Inc. |
| Jul 27, 2022 | Bupivacaine HCl 0.375% w/v and Lidocaine HCl 2% w/v Solution for Retrobulbar ... | Lack of Assurance of Sterility | Class II | Pine Pharmaceuticals, LLC |
| Jul 27, 2022 | Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-coun... | Failed dissolution specifications. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jul 25, 2022 | FentaNYL Citrate in 0.9% Sodium Chloride 1 mg per 100 mL (10 mcg per mL) IV b... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 25, 2022 | Pantoprazole Sodium for Delayed-Release Oral Suspension*40 mg* suspension in ... | Discoloration | Class II | SUN PHARMACEUTICAL INDUSTRIES INC |
| Jul 25, 2022 | fentaNYL Citrate in 0.9% Sodium Chloride, 2.5 mg per 250 mL, (10 mcg per mL) ... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 180 mg, 30-coun... | Failed Dissolution Specifications: below specification limits for dissolution. | Class II | Teva Pharmaceuticals USA Inc |
| Jul 19, 2022 | Luxury 70% Isopropyl Alcohol, First Aid Antiseptic with Wintergreem12 FL. OZ.... | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Jul 19, 2022 | Prednisone Tablets USP, 20 mg, 100-count bottle, Rx Only, Manufactured by: St... | Presence of foreign tablet: 2.5 mg tablet in a 20 mg bottle of Prednisone Tablets | Class II | Strides Pharma Inc. |
| Jul 19, 2022 | Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1 PT) 473 ML, Distributed by: TSM B... | Labeling: Product Contains Undeclared API - product contains undeclared ethyl alcohol | Class II | Tsm Brands LLC |
| Jul 18, 2022 | Irbesartan Tablets, USP, 75 mg, 90- count bottle, Rx only, Manufactured by: J... | Failed Dissolution Specifications | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 18, 2022 | Irbesartan Tablets, USP, 150mg, 90- count bottles, Rx only, Manufactured by: ... | Failed dissolution specifications. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| Jul 15, 2022 | Avant Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9 fl. oz.) ... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Cherry Flavor, 10 ... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | Avant Foaming Hand Sanitizer, ethanol 62%, a) 18 fl. oz. bottle (530 mL), b) ... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Stage 2-Ophardt Foaming Hand Sanitizer, Fragrance-Free, 1000 mL (33.9 fl. oz.... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Fulvestrant Injection 250mg/5mL (50 mg/mL), Contains 2 Single-Dose Prefilled ... | Failed Impurities/Degradation Specifications | Class II | Zydus Pharmaceuticals (USA) Inc |
| Jul 15, 2022 | Protect U Guard Foaming Hand Sanitizer, Fragrance Free, 18 fl/oz. (530 mL) pe... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Protect U Guard Foaming Hand Sanitizer Ophardt, Fragrance Free, 1000 mL (33.9... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Grape Flavor, 10 F... | CGMP Deviations; | Class II | Vi-Jon, LLC |
| Jul 15, 2022 | Common Sense Fragrance Free Hand Sanitizer, 250 Gallon Tote, Microbe Solutio... | CGMP Deviations: product manufactured using deionized water from a system lacking appropriate mic... | Class II | Aire-Master of America Inc |
| Jul 15, 2022 | Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon Flavor, 10 F... | CGMP Deviations | Class II | Vi-Jon, LLC |
| Jul 14, 2022 | Difluprednate Ophthalmic Emulsion, 0.05%, 5ml bottles, Rx only, Mfd. by: Cipl... | Lack of Assurance of Sterility: customer complaint for defective container where breakage of the ... | Class II | CIPLA |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 15 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 13, 2022 | Lansoprazole Delayed-Release Orally Disintegrating Tablets, 35 mg, 100-count ... | FAILED DISSOLUTION SPECIFICATIONS | Class II | Dr. Reddy's Laboratories, Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 4mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vial per carton, Rx Only, No... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Naftifine Hydrochloride Gel, USP 1%, packaged in cartons with: a) Net Wt. 90g... | Failed Impurities/ degradation specifications: Out-of-Specification test results obtained for Uns... | Class II | Tolmar, Inc. |
| Jul 11, 2022 | Ativan Injection (lorazepam injection, USP), 2mg/mL, 1 mL vial, 25 vials per... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 11, 2022 | Lorazepam Injection, USP, 2mg/mL, 1 mL vial, 25 vials per carton, RX Only, M... | Failed Impurities/Degradation Specifications: Out-of-specification results observed for total rel... | Class II | Hikma Pharmaceuticals USA Inc. |
| Jul 7, 2022 | Aripiprazole Tablets, USP 20 mg, packaged in a) 1,000-count bottle (NDC 6050... | Failed dissolution specifications: OOS for dissolution at the 12-month stability time point. | Class II | Apotex Corp. |
| Jun 30, 2022 | Fentanyl Citrate in 0.9% Sodium Chloride Injection, USP, 2500 mcg/250 mL (10 ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | 0.125% Bupivacaine HCl Injection, USP, 62.5 mg/50 mL (1.25 mg/mL) syringes, p... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | HYDROmorphone HCl Injection, USP, 50 mg/50 mL (1 mg/mL) syringes, packaged in... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Glycopyrrolate Injection, USP, 1 mg/5 mL (0.2 mg/mL) syringes, packaged in 5 ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Morphine Sulfate Injection, USP, 50 mg/50 mL (1 mg/mL) syringe, packaged in 5... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Atropine Sulfate Injection, USP 1.2 mg/3 mL (0.4 mg/mL) syringe, packaged in ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | HYDROmorphone HCl Injection, USP 30 mg/30 mL (1 mg/mL) syringe, 5 x 30 mL Pre... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Phenylephrine HCl Injection, USP, 0.4 mg/10 mL (40 mcg/mL) syringe, packaged ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Morphine Sulfate Injection, USP, 2 mg/2 mL (1 mg/mL) syringe, packaged in 5 x... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Neostigmine Methylsulfate Injection, USP, 5 mg/5 mL (1 mg/mL) syringe, packag... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center LLC |
| Jun 30, 2022 | Ketamine HCl Injection, USP 30 mg/3 mL (10 mg/mL*) syringes, packaged in 5 x ... | Lack of Assurance of Sterility | Class II | Nephron Sterile Compounding Center 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.