Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

Clear
DateProductReasonClassFirm
Mar 7, 2022 Testosterone Cypionate (GSO) 200mg/ml a) 2 mL-vial, b) 4 mL-vial, c) 5 mL-via... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Gonadorelin 100mcg/mL, 10mL per vial, Refrigerate, Tailor Made Compounding Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Nandrolone Decanoate 200mg/mL, a) 5 mL-vial, b) 10mL-vial, Refrigerate, Tail... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
Mar 7, 2022 Methylcobalamin 10mg/mL, a) 1 mL-vial, b) 10mL-vial, c) 30 mL-vial, Room Tem... Lack of Assurance of Sterility Class II TMC Acquisition LLC dba Tailor Made Compounding
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 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 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 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 Moxifloxacin Ophthalmic Solution USP 0.5%, 3 mL, Packaged and Distributed By:... Failed impurities/degradation specifications Class II Direct Rx
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 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 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 0.25 mg, packaged in a) 100-count bottles (NDC 67253-... 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 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 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 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 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 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 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.
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.
Jan 28, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 70%), plastic bottle pa... Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... Class II AMS Packaging Inc
Jan 28, 2022 Premium Nature Instant Hand Sanitizer, (ethyl alcohol 65%), plastic bottles p... Subpotent Drug: FDA analysis has revealed some bottles of these products were sub potent for etha... Class II AMS Packaging Inc
Jan 26, 2022 Enoxaparin Sodium Injection, USP, 150MG/ML Single-Dose Syringes with Automati... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 APAP 500 mg tablet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Laboratori... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Ricola CherryHoney Herb Throat Drops (menthol, 1.8 mg), 10 Drops per roll, Ma... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 RIVASTIGMINE TRANSDERMAL SYSTEM, Delivers 4.6 mg/24 hours, 30 systems per box... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Coated APAP 500 mg caplet (Acetaminophen 500 mg) Bulk Container, ULTRAtab Lab... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 AMOXICILLIN for Oral Suspension USP, 400MG/5ML, 100ML (when reconstituted), M... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 3-Component Cold Tabs (Acetaminophen 325 mg, Guaifenesin 200 mg, Phenylephrin... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 ARMOUR THYROID (thyroid tablets, USP), 2 GRAIN (120 mg), 100 Tablets, Rx Only... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Migrenol Caplet (Acetaminophen 500 mg, Caffeine 65 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 AMOXICILLIN Tablets, USP, 875MG, 20 Tablets, Rx Only, Manufactured by Sandoz ... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 ALLOPURINOL Tablets, USP 300 MG 500 count Tablets per bottle, Rx only, Manufa... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Nutralox Peppermint Antacid (Calcium Carbonate 420 mg) Bulk Container, ULTRAt... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Ephedrine 25 Guaifenesin 200 Tablet (Ephedrine HCl 25 mg, Guaifenesin 200 mg)... CGMP Deviations Class II ULTRAtab Laboratories, Inc.
Jan 26, 2022 Propranolol Hydrochloride Tablets, 20 mg, 100 Tablets per bottle, Rx only, Ma... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE
Jan 26, 2022 Donepezil HCl Tablets, 5 mg, 90 Tablets, Rx only, Distributed by: Solco Healt... CGMP Deviations: Products were exposed to temperatures outside of the products labeled storage co... Class II CARDINAL HEALTHCARE

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.