Browse Drug Recalls

1,732 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,732 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 1,732 FDA drug recalls, Class I.

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DateProductReasonClassFirm
Aug 3, 2021 Lidocaine Hydrochloride Topical Solution, USP, 4% , 50 mL glass bottles, Rx O... Superpotent Drug Class I Teligent Pharma, Inc.
Aug 2, 2021 365 SKINNY High Intensity Capsules, 600 mg, 30-count bottle, BODY BALANCE IN... Marketed Without an Approved NDA/ANDA: FDA analysis found the product to be tainted with undeclar... Class I Je Dois Lavoir LLC
Jul 16, 2021 ALPHA MALE+ Male Enhancer, fruit chew strips, 1 strip per foil pouch, Distrib... Marketed Without an Approved NDA/ANDA: FDA analysis determined the presence of tadalafil Class I Alpha-Tek LLC
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... Chemical Contamination: presence of benzene Class I Johnson & Johnson Consumer, Inc.
Jul 14, 2021 Vy&Tea (Vietnamese Labeling with a green leaf and a bird underneath) 15/KLT 4... Marketed Without An Approved NDA/ANDA: FDA analysis detected the presence of sibutramine. Class I Qikmoov LLC
Jul 14, 2021 Neutrogena Beach Defense water+sun protection sunscreen spray BROAD SPECTRUM ... Chemical Contamination: presence of benzene Class I Johnson & Johnson Consumer, Inc.
Jul 2, 2021 Atovaquone Oral Suspension, USP, 750 mg/5 mL, 210 mL bottle, Rx Only, Mfd. By... Temperature abuse: the firm received customer complaints of unusual grittiness in the product. Class I KVK-Tech, Inc.
Jun 22, 2021 Limar Hand Sanitizer, Isopropyl Alcohol 70%, Cont. 4 oz bottles, Manufactured... Labeling Not Elsewhere Classified: Hand sanitizer packaged in containers resembling drinking wate... Class I Ardil Comercial S.R.L.
Jun 21, 2021 Prairie Wolf Distillery Alcohol Antiseptic 80%, Topical Solution Hand Sanitiz... Hand sanitizer packaged in bottles that resemble beverage containers. Class I Prairie Wolf Spirits
Jun 18, 2021 Topotecan Injection 4 mg/4mL (1 mg/mL), Single-Dose vial, Teva Pharmaceutical... Presence of Particulate Matter: Complaint received of a glass particle observed inside the vial. ... Class I Teva Pharmaceuticals USA
May 18, 2021 PremierZEN Platinum 8000 capsule, 1-count blister card (UPC 7 28175 42185 6),... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
May 18, 2021 maXXzen Platinum 12000 capsule, 1-count blister card (UPC 7 18122 04072 8), D... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
May 18, 2021 PremierZEN Gold 7000 capsule, 1-count blister card, packaged in 12 cards per ... Marketed without an approved NDA/ANDA - Product found to be tainted with Sildenafil and Tadalafil. Class I Miracle 8989
May 12, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... Class I Global Sanitizers LLC
May 12, 2021 MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICROBIAL FORMULA, (Ethyl Alcohol 70... Chemical Contamination: FDA analysis found 1 lot of MEDICALLY MINDED Hand Sanitizer Gel, ANTIMICR... Class I Global Sanitizers LLC
May 11, 2021 Poseidon Platinum 3500 capsule, 1-count per blister card, Distributed by: Pos... Marketed Without An Approved NDA/ANDA: Product found to contain undeclared sildenafil and tadalaf... Class I Yamtun7
May 11, 2021 C-PROGESTERONE OIL 100 MG/ML, 10 mL vials, Compound, People's Custom Rx, Comp... Non-Sterility Class I People's Custom Rx and Clinical Care, LLC
May 11, 2021 DiBAR LABS Hand Sanitizer (ethyl alcohol 70%), 8 FL OZ. (236.5 mL), Distribut... Chemical Contamination: FDA analysis found 3 lots of DiBAR hand Sanitizer to be below the label c... Class I DIBAR NUTRICIONAL S DE RL DE CV
May 3, 2021 1% Lidocaine HCl Injection, USP, 300 mg/30 mL (10 mg/mL), 30 mL Single-dose v... Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... Class I PFIZER, INC
May 3, 2021 0.5% Bupivacaine Hydrochloride Injection, USP, 150 mg/30 mL (5 mg/mL), 30 mL ... Labeling: Label Mix-Up: some vials labeled to contain 0.5% Bupivacaine Hydrochloride Injection, U... Class I PFIZER, INC
Apr 29, 2021 NP Thyroid 15 Thyroid Tablets, USP 1/4 grain (15 mg), packaged in a) 100-coun... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 30 Thyroid Tablets, USP 1/2 grain (30 mg), packaged in a) 100-coun... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 120 Thyroid Tablets, USP 2 grain (120 mg), packaged in a) 100-coun... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 60 Thyroid Tablets, USP 1 grain (60 mg) 100-count bottles, Rx Only... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 29, 2021 NP Thyroid 90 Thyroid Tablets, USP 1&1/2 grain (90 mg) 100-count bottles, Rx ... Subpotent Drug Class I Acella Pharmaceuticals, LLC
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Champagne Bubbles, Anti-Bacterial Spray, 3.38... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Coconut Breeze Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topi... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Ulta beauty Fresh Lemon Citron Frais, 70% Alcohol Hand Sanitizer Spray, Net W... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Watermelon Lemonade, Anti-Bacterial Spray, 3.... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Tangerine & Guava Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile T... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Blueberry Limeade, Anti-Bacterial Spray, 3.38... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Red, White & Blue Anti-Bacterial Spray, 3.38 ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Dragonfruit Splash, Anti-Bacterial Spray, 3.3... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Marshmallows, Anti-Bacterial Spray, 3.38 FL. ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Eucalyptus Mint Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Top... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Optimistic Vibes, Anti-Bacterial Spray, 3.38 ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Tropical Daydream, Anti-Bacterial Spray, 3.38... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Lemon Zest Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile Topical ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Coconut Stand CoCo TKO Hand Sanitizer, Totally Knocks Out 99.9% of Germs, 3.4... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Grape Soda, Anti-Bacterial Spray, 3.38 FL. OZ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Melon Picnic, Anti-Bacterial Spray, 3.38 FL. ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 SS Lavender & Herbs Scented Sanitizer, Alcohol Antiseptic 70%, Non-sterile To... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Limoncello, Anti-Bacterial Spray, 3.38 FL. OZ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 27, 2021 Goose Creek Hand Sanitizer aloe Beach Dreams, Anti-Bacterial Spray, 3.38 FL. ... Chemical contamination: product found to be contaminated with methanol (wood alcohol), benzene an... Class I Scentsational Soaps & Candles Inc
Apr 20, 2021 BD ChloraPrep Hi-Lite Orange 26 mL Applicator (2% w/v chlorhexidine gluconate... Defective Delivery System: An increase in complaints identified endcap being loose or falling off... Class I CareFusion 213, LLC
Apr 8, 2021 Ginseng Power 5000 capsule, 1- count per blister card, GS Natural Co, Los Ang... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... Class I NSNY Distributor Inc
Apr 8, 2021 Premium OrgaZEN 7000 capsule, 1-count per blister card, distributed by: Nutra... Marketed without an approved NDA/ANDA: Products found to contain undeclared sildenafil and/ or ta... Class I NSNY Distributor Inc
Mar 30, 2021 Krazy Night capsule, packaged in a) 1-count per blister card and b) 10-count ... Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... Class I Ummzy, LLC
Mar 30, 2021 Shogun-X capsules, 10-count boxes, Manufactured by Power Life Distributors, M... Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... Class I Ummzy, LLC
Mar 30, 2021 Thumbs up 7 Red 70K capsules, 10-count boxes, Distributed Ummzy LLC, Made in ... Marketed Without An Approved NDA/ANDA: Products found to contain undeclared tadalafil and/ or sil... Class I Ummzy, 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.