Browse Drug Recalls

14,572 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,572 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 14,572 FDA drug recalls, Class II.

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DateProductReasonClassFirm
May 29, 2026 Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 1 gallon (3.78 liter), ... Subpotent drug Class II Gasco Industrial Corp.
May 29, 2026 Gasco Isopropyl Alcohol 70%, Net Contents: 16 Oz. (474 mL). Manufactured by: ... Subpotent drug Class II Gasco Industrial Corp.
May 29, 2026 Drogueria San Juan Puerto Rico Isopropyl Alcohol 70%, 32 oz., 946 mL, Distrib... Subpotent drug Class II Gasco Industrial Corp.
May 29, 2026 Gasco Isopropyl Alcohol 70%, 32 oz (946 mL) Gasco Industrial Corp., PO Box 13... Subpotent drug Class II Gasco Industrial Corp.
May 29, 2026 Gasco Isopropyl Alcohol 70%, Net Contents: 1 US Gallon (3.78 L), Manufactured... Subpotent drug Class II Gasco Industrial Corp.
May 29, 2026 GSMS Incorporated, NIACIN EXTENDED-RELEASE TABLETS, USP, 1,000 MG, 90 tablets... Failed Dissolution Specifications: During 12-month long-term stability testing, subject lot was o... Class II Golden State Medical Supply Inc.
May 29, 2026 Budesonide Inhalation Suspension, 1mg/2mL, 30 x 2 mL Sterile Single-Dose Ampu... Presence of Foreign Substance:This recall has been initiated in response to a product quality com... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 28, 2026 BD ChloraPrep FREPP Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v ... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
May 28, 2026 Fenofibrate Capsules, USP 200 mg, Rx only, 100 Capsules, Manufactured by: Aja... CGMP Deviations Class II Ajanta Pharma USA Inc
May 28, 2026 BD ChloraPrep Clear, (2% w/v chlorhexidine gluconate (CHG) and 70% v/v isopro... Lack of Assurance of Sterility: Due to wrinkles in the paper lidding which may breach the seal ... Class II CareFusion 213, LLC
May 28, 2026 KIRKLAND Signature, ULTRA STRENGTH ANTACID, Calcium Carbonate, 1000 mg, 265-c... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 7... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 750 mg, chew... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Harris Teeter, ULTRA STRENGTH ANTACID, Calcium Carbonate 1000 mg, 72 CHEWABLE... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 H.E.B Extra Strength Calcium Carbonate Antacid Tablets, Calcium Carbonate 750... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 24/7 life BY 7-ELEVEN, Extra strength Antacid Tablets, Calcium Carbonate 750 ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 MARKET BASKET ANTACID Calcium Carbonate 1000 mg, ULTRA STRENGTH, 72 Tablets, ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 FAMILY WELLNESS, ULTRA STRENGT, ANTACID TABLETS, Calcium Carbonate 1000 mg, 7... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 TopCare health, EXTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 750mg, 96 ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Extra strength Antacid Calcium Carbonate 750 mg, chewable tablets, 96-count b... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 Good Neighbor Pharmacy, extra strength Antacid Calcium Carbonate 1000 mg, 72 ... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 EQUALINE extra strength, antacid tablets, calcium carbonate 750mg, 96 chewabl... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 GOODSENSE Extra Strength, Antacid TABLETS, Calcium Carbonate 750 mg, 96 Chewa... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 EQUALINE ultra strength, antacid tablets, calcium carbonate 1000mg, 72 chewab... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 CAREone, ULTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 1000 mg, 72 chewab... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 DISCOUNT drug mart, EXTRA STRENGTH, ANTACID TABLETS, Calcium Carbonate 750 mg... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 750 mg, 330-co... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 GOODSENSE Ultra Strength, Antacid TABLETS, Calcium Carbonate 1000 mg, 72 Chew... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 TopCare health, ULTRA STRENGTH, Antacid Tablets, CALCIUM CARBONATE 1000mg, 72... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 HyVee, Extra Strength Antacid, Calcium Carbonate 750 mg, 96 CHEWABLE TABLETS,... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 CAREone, EXTRA STRENGTH CALCIUM ANTACID, Calcium Carbonate 750 mg, 96 chewabl... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 HyVee, Ultra Strength Antacid, Calcium Carbonate 1000 mg, 72 CHEWABLE TABLETS... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 28, 2026 HALEON CALCIUM CARBONATE TUMS ANTACID, Assorted Fruit Tablets, 1000 mg, 160-c... Presence of foreign substance: small metallic particles in chewable tablets. Class II Guardian Drug Co. Inc.
May 27, 2026 Alyacen 7/7/7, Norethindrone and Ethinyl Estradiol Tablets USP, 0.5mg/0.035mg... Failed Impurities/Degradation Specifications: This recall is being initiated due to out-of-specif... Class II Glenmark Pharmaceuticals Inc., USA
May 27, 2026 Aripiprazole Tablets USP, Rx only, 30 mg, 30 tablets, Marketed by: Ajanta Pha... Product Mix-Up: A bottle containing Voriconazole Tablets 50 mg was labelled and distributed as A... Class II Ajanta Pharma USA Inc
May 27, 2026 Niacin Extended-release Tablets, USP, 1,000 mg, 90-count bottles, Rx Only, Di... Failed Dissolution Specifications: during 12M LT stability testing OOS low for Stage 3 dissolutio... Class II Lannett Company Inc.
May 22, 2026 Xyvona (levorphanol tartrate tablets), 3mg, 100 Tablets, Rx only, Forte BioPh... Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 22, 2026 Xyvona (levorphanol tartrate tablets), 2mg, 100 Tablets, Rx only, Forte BioPh... Labeling: Not Elsewhere Classified. This recall has been initiated in response to the denial by F... Class II SUN PHARMACEUTICAL INDUSTRIES INC
May 22, 2026 Zep, Alcohol Sanitizer Spray, Ethanol 70%, Net Contents 55 Gallons 208 Liters... Microbial contamination of sterile products Class II Zep Inc
May 21, 2026 Pearson Quality Topical Anesthetic Gel (20% Benzocaine), Mint Flavor, Net Con... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 safco SensiCaine-Ultra (20% Benzocaine), Topical Anesthetic Gel, Strawberry F... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 Dental City TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, Strawberry Flavor, 1 OZ ... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 Burkhart topical anesthetic gel, benzocaine 20 %, Strawberry Flavor, 1 oz (30... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 Quala Dental Products, Topical Anesthetic Gel, 20 % Benzocaine, Strawberry Fl... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 PureLife, TOPICAL ANESTHETIC GEL, BENZOCAINE 20%, 1 oz (30mL), Strawberry Fl... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 21, 2026 DHP Topical Anesthetic Gel, Benzocaine 20%, Strawberry Flavor, 1 oz. (30 g), ... Defective container:may contain bottles with incomplete seals Class II Keystone Industries
May 19, 2026 Clomiphene Citrate USP Active Pharmaceutical Ingredient (CAS : 50-41-9), Net ... cGMP deviations Class II Shimoga Chemicals
May 18, 2026 PReye Vitamin See Antioxidant Preservative Free Eye Drops, Distributed by: PR... Lack of Assurance of Sterility Class II PReye LLC
May 18, 2026 Vasopressin 2 Units/2 mL in 0.9% Sodium Chloride, syringe, IntegraDose Compou... Subpotent Drug Class II IntegraDose Compounding Services LLC
May 15, 2026 VistaPharm, KERR INSTA-CHAR IN AN SORBITOL BASE WITH CHERRY FLAVOR, 50 Grams ... Does Not Meet USP or OTC Monograph: Product did not meet the Over-the-Counter (OTC) Monograph M023 Class II PAI Holdings 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.