Browse Drug Recalls
1,392 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 1,392 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 1,392 FDA drug recalls in 2022.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| Aug 10, 2022 | PF-0.125% Bupivacaine HCl Injection, USP, 625 mg/500 mL (1.25 mg/mL), 500 mL ... | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Class II | Nephron Sterile Compounding Center LLC |
| Aug 10, 2022 | Colgate Anticavity Fluoride Toothpaste OPTIC WHITE STAIN FIGHTER CLEAN MINT P... | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Class II | Family Dollar Stores, Llc. |
| Aug 10, 2022 | Ketorolac Tromethamine Injection, USP 60 mg/2 mL (30 mg/mL), packaged in 2 mL... | cGMP Deviations: deviations leading to potential cross-contamination. | Class II | Nephron Sc Inc |
| Aug 10, 2022 | Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE ADVANCED ICY FRESH, Net W... | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Class II | Family Dollar Stores, Llc. |
| Aug 10, 2022 | PF-Labetalol HCl Injection, USP, 20 mg/4 mL (5 mg/mL), One 4 mL Unit-Dose Via... | CGMP Deviations: Potential for cross-contamination due to product carryover during manufacturing. | Class II | Nephron Sterile Compounding Center LLC |
| 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 10, 2022 | Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE with CHARCOAL COOL MINT P... | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Class II | Family Dollar Stores, Llc. |
| Aug 10, 2022 | Colgate Anticavity Fluoride Toothpaste, OPTIC WHITE PRO SERIES, Stain Prevent... | cGMP deviation: Product held outside of appropriate temperature storage conditions. | Class II | Family Dollar Stores, Llc. |
| 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 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 | Timolol Maleate Ophthalmic Solution, USP, 0.5%, 5 x 0.3 mL Single-Dose Vials,... | Identification of an unknown impurity at the 12-month stability point. Further investigation has ... | Class III | Akorn, Inc |
| 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 4, 2022 | Acetaminophen 325 mg tablets, packaged in a) 100-count bottle (NDC 71399-802... | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Class III | Akron Pharma, Inc. |
| Aug 4, 2022 | Acetaminophen 500 mg tablet, Extra Strength, packaged in a) 100-count bottle ... | Failed Tablet/Capsule Specifications: Imprint "AP 325" is missing from the tablet. | Class III | Akron Pharma, Inc. |
| Aug 4, 2022 | Nighttime Sleep-Aid (doxylamine succinate HCl) tablets, 25 mg, 48-count blist... | Labeling: Not Elsewhere Classified: Carton incorrectly identifies product as doxylamine succinate... | Class III | LNK International, Inc. |
| Aug 2, 2022 | Zynrelef (bupivacaine and meloxicam), 400 mg bupivacaine and 12 mg meloxicam ... | Defective Delivery System: An incorrect 10 mL (12 mL) Luer (slip) syringe packaged in one lot of ... | Class III | HERON THERAPEUTICS, INC. |
| 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 29, 2022 | Banana Boat hair & scalp defense, Clear Sunscreen Spray SPF 30, Avobenzone 2.... | Chemical contamination: presence of benzene | Class I | Edgewell Personal Care Brands, LLC |
| 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 | Divalproex Sodium Extended Release Tablets, USP, 250 mg, packaged in 100-coun... | Failed dissolution specifications. | Class II | Amneal Pharmaceuticals of New York, LLC |
| Jul 27, 2022 | Azacitidine for Injection, 100 mg Lyophilized Powder, Single-Dose Vials, Rx O... | Subpotent Drug | Class III | Amerisource Health Services LLC |
| 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 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 1 mg per 100 mL (10 mcg per mL) IV b... | Lack of Assurance of Sterility | Class II | SterRx, LLC |
| 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 22, 2022 | SANGTER Energy Supplement Capsules, 3000mg x 7 grain, 7-count blister pack wi... | Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with sildenafil. | Class I | Distributor RFR, LLC. |
| Jul 22, 2022 | Azacitidine for Injection 100mg/vial Lyophilized Powder, Rx Only, Mfd. in Rom... | Subpotent Drug - Out of specification (OOS) result obtained during monitoring stability study for... | Class III | Teva Pharmaceuticals USA Inc |
| Jul 21, 2022 | SUSTANGO (Pendenadril Tytrate Blend) Capsules, 400 mg, 10-count blisters per ... | Marketed Without an Approved NDA/ANDA: Analytical testing showed the presence of tadalafil. | Class I | Ultra Supplement LLC |
| 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 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 20, 2022 | Lamotrigine Tablets, USP 100 mg, 1000-count bottles, Rx Only, Manufactured fo... | Labeling: Label Error on Declared Strength | Class III | AVKARE 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, 150mg, 90- count bottles, Rx only, Manufactured by: ... | Failed dissolution specifications. | Class II | Jubilant Cadista Pharmaceuticals, Inc. |
| 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 15, 2022 | equate Magnesium Citrate, SALINE LAXATIVE, (1.745g/fl oz) 10 FL OZ (296mL), G... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | EQUALINE magnesium citrate saline laxative, oral solution, (1.745 g/fl oz), D... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Topcare health, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.745 g/f... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| 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 | 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 | Walgreens, Dye-Free, Magnesium Citrate, SALINE LAXATIVE, Oral Solution, (1.74... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| 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 | CVS Health, Magnesium Citrate SALINE LAXATIVE, Oral Solution, (1.745 g/fl oz)... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| Jul 15, 2022 | Rexall, Magnesium Citrate Saline Laxative, Oral Solution, (1.745 g/fl oz), Le... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| 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 | SWAN, Citroma MAGNESIUM CITRATE, Saline Laxative, Oral Solution, (1.745 g/fl ... | Microbial contamination of non-sterile products. | Class I | Vi-Jon, LLC |
| 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 |
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.