Browse Drug Recalls

18,008 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,008 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 18,008 FDA drug recalls.

DateProductReasonClassFirm
Mar 4, 2022 Alprazolam C-IV 1 mg 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical ... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Alprazolam C-IV 2 mg, 60-count bottles, Rx Only, Dist. By: Par Pharmaceutical... CGMP Deviations: The Recall is due to the potential cross-contamination at the contract manufactu... Class II Direct Rx
Mar 4, 2022 Nandrolone Decanoate, USP, 1 kg per plastic container, Rx Only, For Prescript... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 100 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 4, 2022 SyrSpend SF Suspending Base, Cherry Flavored, packaged in a) 500mL bottles (N... Microbial Contamination of Non-Sterile Product: Product is contaminated with Burkholderia gladioli. Class I Fagron, Inc
Mar 4, 2022 Nandrolone Decanoate, USP, 500 g per plastic container, Rx Only, For Prescrip... Subpotent Drug Class III Fagron, Inc
Mar 3, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... Chemical Contamination: FDA analysis found 1 lot of HAND SANITIZER Isopropyl Alcohol Antiseptic... Class I Tennessee Technical Coatings, Corp.
Mar 3, 2022 HAND SANITIZER Isopropyl Alcohol Antiseptic 75%, Net contents: 1 U.S. Gallon/... CGMP Deviations: lots and products of hand sanitizer are being recalled because they were manufac... Class II Tennessee Technical Coatings, Corp.
Mar 2, 2022 Alprazolam Tablets, USP 1mg, 180-count bottles, Rx only, Manufactured by ULTR... CGMP Deviation: Potential cross-contamination with other drug substance during the manufacturing ... Class II Golden State Medical Supply Inc.
Mar 2, 2022 HEB 50% Isopropyl Alcohol First Aid Antiseptic, packaged in 16 FL OZ 91 PT) 4... Labeling: Label Mix-Up-The primary label on the front of the bottles have 50% Isopropyl Alcohol a... Class II Vi-Jon, Inc.
Feb 28, 2022 PALIPERIDONE EXTENDED-RELEASE TABLETS, 9 mg, 100 Tablets per carton (10 x 10 ... Failed Dissolution Specifications Class II The Harvard Drug Group
Feb 25, 2022 Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%,15 g tubes, R... Failed Content Uniformity Specifications: Out-of-specification result for the Betamethasone Dipro... Class III Taro Pharmaceuticals U.S.A., Inc.
Feb 25, 2022 0.9% Sodium Chloride Injection USP, 250 mL Excel Container, Rx only, B. Braun... Lack of sterility assurance: leaking bags Class II B. Braun Medical, Inc.
Feb 24, 2022 hydrALAZINE HCl Tablets, USP, 10 mg, 100 Tablets per carton (10x10 blister pa... Failed Impurities/Degradation Specifications: Out of specification result obtained during routine... Class II The Harvard Drug Group
Feb 22, 2022 Oxycodone Hydrochloride Oral Solution, USP (C-II), 5 mg/5 mL, Delivers 5 mL p... Impurity failure at 0-time of the repackaged lot. Class II American Health Packaging
Feb 22, 2022 Alprazolam Tablets, USP 1mg, Generic for Xanax, Pkg Size: a) 30 tablets per b... CGMP deviations Class II Preferred Pharmaceuticals, Inc.
Feb 21, 2022 Dexamethasone Elixir, USP 0.5 mg/5 mL, Net: 8 fl oz (237 mL) bottle, Rx only,... Failed Impurities/Degradation Specifications: higher than permissible levels of unknown impuritie... Class II Morton Grove Pharmaceuticals, Inc.
Feb 18, 2022 All Over-The-Counter (OTC) drug products sold by Family Dollar retail stores ... CGMP Deviations: Potential exposure to rodents and rodent activity in the distribution center. Class II Dollar Tree Distribution, Inc.
Feb 17, 2022 Sapropterin Dihydrochloride Powder for Oral Solution, 100 mg, 30 individual p... Subpotent Drug: Out-of-specification results observed in Assay in sapropterin dihydrochloride pow... Class III Dr. Reddy's Laboratories, Inc.
Feb 17, 2022 Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By:... Failed impurities/degradation specifications Class II Direct Rx
Feb 16, 2022 Sure Regular Antiperspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%), p... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 16, 2022 Sure Unscented Anti-perspirant Deodorant Aerosol (Aluminum Chlorohydrate 10%)... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 16, 2022 Olanzapine Tablets, USP 10 mg, 30-count bottles, Rx only, Manufactured for: M... cGmp Deviations Class II Macleods Pharma Usa Inc
Feb 16, 2022 Brut Classic Antiperspirant & Deodorant (aluminum chlorohydrate 20.9%) packag... Chemical contamination: Presence of benzene Class I TCP HRB ACQUISITON LLC
Feb 15, 2022 Alprazolam Tablets, USP 0.5 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 0.25 mg, packaged in a) 100-count bottles (NDC 67253-... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Amlodipine and Olmesartan Medoxomil Tablets, 10 mg /20 mg, 30-count bottles, ... cGMP deviations Class II Macleods Pharma Usa Inc
Feb 15, 2022 Alprazolam Tablets, USP 1.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Pyrazinamide Tablets, USP 500 mg, 100-count bottles, Rx only, Manufactured by... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 15, 2022 Alprazolam Tablets, USP 2.0 mg, packaged in a) 100-count bottles (NDC 67253-9... cGMP Deviations Class II ANI Pharmaceuticals, Inc.
Feb 14, 2022 Norepinephrine bitartrate 16 mg in 250 mL NaCl 0.9%, packaged in IV bags, Rx ... Subpotent drug Class III BayCare Integrated Service Center, LLC /dba Bay...
Feb 11, 2022 HCG 6,000iu (lyo) Human Chorionic Gonadotropin Inj., For Sub-Q or IM Use Only... Non-sterility; bacterial contamination identified as Paenibacillus lautus. Class I Revive Rx LLC dba Revive Rx Pharmacy
Feb 10, 2022 RISE UP RED EDITION Capsules, 650 mg, 10-count blisters packaged in a carton,... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... Class I Positive Health
Feb 9, 2022 Avaphinal Maximum Male Enhancement Sexual Pills, 2000 MG*, packaged in 10 Cap... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil, an ing... Class I Walmart Stores
Feb 9, 2022 Diazepam Oral Solution (Concentrate), 25 mg per 5 mL (5 mg/mL), 30 mL BOTTLE ... Failed Impurities/Degradation Specifications: Out of specification results for related substances. Class II Lannett Company, Inc.
Feb 8, 2022 THE RED PILL, EXTRA STRENGTH capsules, 800 mg, packaged in 10-count blisters ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared tadalafil, an ingr... Class I Your Favorite Shop
Feb 8, 2022 MAC DADDY RED Capsules, packaged in 10-count blisters per carton, ASIN B07TLD... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 8, 2022 MAC DADDY PURPLE Capsules, packaged in 10-count blisters per carton, ASIN B08... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil and/or s... Class I ABC Sales 1 Inc
Feb 8, 2022 RED MAMMOTH capsules, 400 mg, packaged in 10-count blisters per carton, ASIN ... Marketed Without An Approved NDA/ANDA: Product was found to contain undeclared sildenafil and tad... Class I Celebrate Today
Feb 7, 2022 Erythromycin Topical Gel USP, 2%, Net Wt 30 g tube, Rx only, Manufactured by:... Failed Impurities/Degradation Specifications: Lot not meeting specification for Unknown Max Relat... Class II Teligent Pharma, Inc.
Feb 7, 2022 70% Isopropyl Alcohol First Aid Antiseptic with Wintergreen, 12 FL. OZ. 355 M... Labeling - product contains undeclared ethyl alcohol Class II Tsm Brands LLC
Feb 7, 2022 Luxury 70% Isopropyl Alcohol, 16 FL. OZ. (1PT) 473 ML bottle, Distributed by:... Labeling - product contains undeclared ethyl alcohol Class II Tsm Brands LLC
Feb 7, 2022 Chlorthalidone Tablets USP 25 mg, Rx Only, 100 Tablets, Sun Pharma, Mfg. by: ... Foreign Matter identified as stainless steel microscopic wear particles mixed with punch lubrican... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Feb 7, 2022 Methylphenidate Hydrochloride Chewable Tablets, 2.5 mg, 100-count bottle, Rx ... Failed Tablet Specifications: Recall of this drug product was voluntarily initiated by the manufa... Class II RISING PHARMACEUTICALS
Feb 4, 2022 MegMan Performance Booster, 800 mg capsules, packaged in 10-count blisters pa... Marketed Without An Approved NDA/ANDA: product was found to contain undeclared tadalafil, an ingr... Class I Junp Hydration LLC
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swabstick, 3.15% w... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Swab, 3.15% w/v an... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, Inc.
Feb 4, 2022 Prevantics (chlorhexidine gluconate and isopropyl alcohol) Maxi Swabstick, 3.... cGMP deviations: uncertainty of the adequacy of the validation of the test methods used to manufa... Class II Professional Disposables International, 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.