Browse Drug Recalls

1,749 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,749 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 1,749 FDA drug recalls, Class I.

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DateProductReasonClassFirm
Jun 25, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, a).100-... Failed Dissolution Specifications Class I Amerisource Health Services LLC
Jun 21, 2024 Acetaminophen Extra Strength Tablets, 500 mg each, 100 count bottles, Package... Labeling: Label Mix-Up: Some bottles of Acetaminophen Extra Strength 500 mg tablets were incorrec... Class I A-S Medication Solutions LLC
Jun 5, 2024 STELLALIFE VEGA Oral Care, Spray, Unflavored, 1 fl oz (30 ml) bottles, Distri... Microbial Contamination of Non-Sterile Products: multiple Bacillus species organisms Class I Homeocare Laboratories, Inc.
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 100-cou... Failed Dissolution Specifications Class I Glenmark Pharmaceuticals Inc., USA
May 30, 2024 Potassium Chloride Extended-Release Capsules, USP, (750 mg) 10 mEq K, 500-cou... Failed Dissolution Specifications Class I Glenmark Pharmaceuticals Inc., USA
May 28, 2024 Docetaxel Injection, USP, 80 mg per 8 mL (10 mg per mL), 1 x 8 mL Multi-Dose ... Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Class I Sagent Pharmaceuticals
May 28, 2024 Docetaxel Injection, USP, 160 mg per 16 mL (10 mg per mL), 1 x 16 mL Multi-Do... Presence of Particulate Matter: Presence of particulate matter from the stopper in the drug product. Class I Sagent Pharmaceuticals
May 24, 2024 suntegrity, (Zinc Oxide 15%) IMPECCABLE SKIN sunscreen foundation, BUFF, Broa... Microbial Contamination of Non-Sterile Products: Presence of Aspergillus Sydowii (Mold) Class I SYNCHRONICITY SPA INC, DBA SUNTE
Apr 29, 2024 Phenylephrine in 0.9% Sodium Chloride Injection Preservative Free, 100mcg/mL,... Labeling: Label mix-up - ephedrine syringes mislabeled as phenylephrine. Class I Hikma Injectables USA Inc
Apr 22, 2024 Schwinnng Herbal Dietary Supplement Capsules, packaged in 10-count boxes, dis... Marketed Without An Approved NDA/ANDA Class I Stop Clopez Corp
Apr 20, 2024 Tirzepatide 10 mg/0.5 mL Sterile Solution, 2 mL Multi-dose vial, Rx only, Thi... Labeling: Label Mix-up - product labeled as tirzepatide contains testosterone cypionate Class I Revive Rx LLC dba Revive Rx Pharmacy
Apr 8, 2024 Javygtor (sapropterin dihydrochloride) Powder for Oral Solution 100mg, 30 ind... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Apr 8, 2024 Sapropterin Dihydrochloride Powder for Oral Solution 100mg, 30 individual pac... Sub-potent Drug; powder discoloration associated with decreased potency Class I Dr. Reddy's Laboratories, Inc.
Mar 28, 2024 Atovaquone Oral Suspension USP, 750 mg per 5 mL sachets, 20 Units x 5 mL cart... Microbial contamination of a non-sterile product: potential Bacillus cereus contamination. Class I AvKARE
Mar 23, 2024 Aruba Aloe Hand Sanitizer Gel, 80% Alcohol, 12 fl oz (355 mL) plastic bottle,... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 23, 2024 Alcoholada Gel, Pain Relieving Gel, 0.5% Lidocaine Hydrochloride, packaged in... Chemical Contamination: Product manufactured with ethanol API that contains methanol Class I Aruba Aloe Balm N.V.
Mar 21, 2024 Vancomycin Hydrochloride for Oral Solution, USP, 250 mg per 5 mL, packaged as... Superpotent Drug: Due to overfilling of drug powder Class I Amneal Pharmaceuticals of New York, LLC
Mar 19, 2024 GoHARD 25000, Male Sexual Enhancement, Honey, 100% Natural, UPC: N/A. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 libigrow RED DRAGON+, Maximum Strength Formula, 2 capsules per box, UPC 7 05... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 The GOAT SUBLINGUAL STRIP, MALE ENHANCEMENT, 2 Pack, Distributed by Hombres L... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 SILVERBACK XXX POWER MALE ENHANCEMENT, 2 fl. oz., UPC 8 700470 032762 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 HONEY MANUKA BUNNY LOVE, 12g, All Natural Sexual Enhancement, UPC: N/A Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 ALPHASTRIP MALE PERFORMANCE ENHANCER, The fastest acting sublingual, Serving ... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Samurai-X Honey 6800, UPC 2 56891 27553 3. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Spanish Fly 22K capsules, 2-count box, UPC 0 664979 979455 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Pink Pussycat Honey, net wt: 20gx12 sachets, UPC 7 918750 046557 Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Flower Power, CBD infused Female Enhancement, 59 ml bottle, UPC 0 678741 351646. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 19, 2024 Weiner Boner Honey, 12g packet, 100% Organic Formula. Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/or tad... Class I Pyramids Wholesale Inc.
Mar 4, 2024 Treprostinil Injection, 20 mg/20 mL (1 mg/mL), For Subcutaneous or Intravenou... Presence of Particulate Matter. Class I Par Sterile Products LLC
Feb 15, 2024 Methocarbamol Injection, USP 1000mg/10mL, (100mg/mL), 10 mL Single-Dose Vial ... Presence of Particulate Matter Class I Eugia US LLC
Feb 12, 2024 ForeverMen Natural Energy Boost Capsules, packaged in a box containing a 10-c... Marketed Without an Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... Class I FA Online Inc
Feb 6, 2024 Sustain Herbal Dietary Supplement, packaged in 10 capsules per box, Distribut... Marketed Without An Approved NDA/ANDA: FDA analysis found this product to be tainted with undecla... Class I Today The World
Feb 6, 2024 SCHWINNNG Herbal Dietary Supplement, packaged in 10 capsules per box, Distrib... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Today The World
Feb 6, 2024 Arize Herbal Dietary Supplement, packaged in 10 capsules per box, Distributed... Marketed Without An Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Today The World
Feb 5, 2024 Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl.oz. (10 mL) bottle, D... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Super Chill Products
Feb 1, 2024 To the Moon Capsules, Horny Goat Weed, 1000 mg, packaged in a box containing ... Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. Class I Integrity Products
Feb 1, 2024 RAM IT, Horny Goat Weed, dietary supplement capsules, 1000 mg, packaged in a ... Marketed Without an Approved NDA/ANDA: Products contain undeclared sildenafil. Class I Integrity Products
Feb 1, 2024 TING 1% Tolnaftate Athlete's Foot Spray Antifungal Spray Liquid, NET WT 4.5 o... Chemical Contamination; presence of benzene. Class I Insight Pharmaceuticals LLC, a Prestige Consume...
Jan 12, 2024 Neptune's Fix, Tianeptine Elixir, Fast Acting, 0.338 fl oz (10 mL) bottle, Di... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Neptune Resources, LLC
Jan 12, 2024 Neptune's Fix, Tianeptine Extra Strength Elixir, 0.338 fl oz (10 mL) bottle, ... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Neptune Resources, LLC
Jan 12, 2024 Neptune's Fix, Tianeptine Tablets Extended Relief, Twenty Tablets per Box, Wi... Marketed without an approved NDA/ANDA: Product contains tianeptine, a substance not FDA-approved ... Class I Neptune Resources, LLC
Jan 4, 2024 Zenzedi (Dextroamphetamine Sulfate) CII Tablets, USP, 30 mg, 30-count bottle,... Labeling: Label Mix-up Class I Azurity Pharmaceuticals, Inc.
Dec 28, 2023 PHENYLephrine HCl 40 mg per 250 mL 0.9% Sodium Chloride (160 mcg per mL), Ite... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 PHENYLephrine HCl 20 mg per 250 mL 0.9% Sodium Chloride (80 mcg per mL), Item... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 FentaNYL citrate PF, 2500 mcg per 250 mL 0.9% Sodium Chloride (10 mcg per mL)... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 VANCOmycin HCl PF 1.5g added to 0.9% Sodium Chloride 250 mL IV bag, Item F320... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 FentaNYL citrate PF, 1000 mcg per 100 mL 0.9% Sodium Chloride (10 mcg per mL)... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 28, 2023 VANCOmycin HCl PF 1.25g added to 0.9% Sodium Chloride 250 mL IV bag, Item F32... Superpotent Drug: semi-automated IV bag filling system can malfunction and provide a double dose ... Class I Denver Solutions, LLC DBA Leiters Health
Dec 26, 2023 Robitussin Honey CF Max Non-Drowsy Adult (Acetaminophen 650mg, Dextromethorph... Microbial Contamination of Non-Sterile Products Class I Haleon US Holdings LLC
Dec 26, 2023 Robitussin Honey CF Max Nighttime Adult (Acetaminophen 650 mg, Diphenhydramin... Microbial Contamination of Non-Sterile Products Class I Haleon US 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.