Browse Drug Recalls

1,681 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,681 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 1,681 FDA drug recalls in 2018.

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DateProductReasonClassFirm
Feb 9, 2018 Diphenhydramine HCl USP f (or prescription compounding , packaged in a) 25g (... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Progesterone USP (Micronized) (Yam) for prescription compounding, packaged i... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Fluconazole USP for prescription compounding, packaged in a) 25g (NDC 58597-8... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Ascorbic Acid USP, for prescription compounding, packaged in a) 100g (NDC 585... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Itraconazole USP (Micronized) for prescription compounding, packaged in a) 1... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 9, 2018 Levocetirizine Dihydrochloride for prescription compounding, packaged in a) 2... CGMP Deviations: Lack of stability data and controls to support the manufacturers assigned retest... Class II American Pharmaceutical Ingredients LLC
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 7, 2018 BonaDur For Men (lidocaine) spray, 10 mg per spray, Net Contents .25 fl. oz. ... CGMP Deviations: not manufactured according to current good manufacturing practices. Class III Webrx dba RxPalace.com
Feb 7, 2018 Hydromorphone, Hydrochloride, Injection, USP CII, 10 mg/mL, Rx Only, 1 mL Sin... Non-Sterility: Confirmed customer complaints of glass product container vials that may be empty o... Class I Pfizer Inc.
Feb 5, 2018 Klonopin (clonazepam) 0.5 mg Tablets,100-count bottle, Rx only. Made in Canad... Labeling: Not Elsewhere Classified: Schedule IV controlled substance indicator of CIV being omitt... Class III Genentech, Inc.
Feb 5, 2018 Azelastine HCl Nasal Solution (Nasal Spray) 0.1% (137 mcg per spray), 30 mL, ... Sun Pharmaceutical is recalling Azelastine HCl Nasal Solution, 0.1% (30 mL Bottle) following a fa... Class III Sun Pharmaceutical Industries, Inc.
Feb 5, 2018 0.2% Ropivacaine HCI (Preservative Free) in 0.9 Sodium Chloride, Epidural, 25... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 Fluoxetine Tablets USP, 10 mg, 30-count bottle, Rx only, Manufactured in Isra... Failed impurities/ degradation specifications: Teva Pharmaceuticals USA, Inc. is voluntarily reca... Class III Teva Pharmaceuticals USA
Feb 5, 2018 100 mcg / mL Phenylephrine HCl (Preservative Free) Injection, 10 mL syringe,... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 5, 2018 15 units Oxytocin added to 0.9% Sodium Chloride Injection, 250 mL Viaflex Bag... Lack of assurance of sterility: Three lots were released where there was a failure to follow prop... Class II PharMEDium Services, LLC
Feb 2, 2018 Metformin Hydrochloride Tablets, USP 1000 mg, 500-count bottles, Rx Only, M... Presence of Foreign Tablet: Metformin BP 1000mg was found in bottle of Metformin HCl 1000mg Class III Aurobindo Pharma Ltd.
Feb 2, 2018 NORCO (Hydrocodone Bitartrate and Acetaminophen) Tablets, USP, 10 mg/325 mg, ... Labeling: Not Elsewhere Classified: does not have the required "CII" controlled drug classificati... Class III ALLERGAN
Jan 30, 2018 VELCADE (bortezomib) for injection, 3.5 mg/vial, Reconstitution Information, ... Defective Container: Confirmed reports of loose vial crimps. Class II Millennium Pharmaceuticals Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 10 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Atorvastatin Calcium Tablets 40 mg, 90 count bottles, Rx only, Mfd by: Dr. Re... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Fentanyl Transdermal System. 25 mcg/h, packaged in 5 pouch system cartons (ND... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System, 100 mcg/h, packaged in 5 pouch system (NDC 0591-... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Fentanyl Transdermal System, 50 mcg/h, packaged in 5 pouch system cartons (ND... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 29, 2018 Megestrol Acetate Oral Suspension, USP 400 mg/ 10mL (10 mL UD cups in boxes o... Subpotent Drug: Out of specification for assay (stability testing) Class III Mckesson Packaging Services
Jan 29, 2018 Atorvastatin Calcium Tablets 20 mg, a) 90 count and b) 500 count bottles, Rx ... Failed Impurities/Degradations Specifications; out-of-specification results observed for Total De... Class III Dr. Reddy's Laboratories, Inc.
Jan 29, 2018 Fentanyl Transdermal System. 75 mcg/h, packaged in 5 pouch system (NDC 0591-3... Failed Impurities/Degradation Specifications: Fentanyl-n-Oxide (FNO) degradant exceeding the spec... Class III Teva Pharmaceuticals USA
Jan 26, 2018 Limbrel (flavocoxid 500 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel (flavocoxid 250 mg) capsules, 60-count bottle, Rx only, Manufactured ... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel250 (flavocoxid and citrated zinc bisglycinate) 250 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 26, 2018 Limbrel500 (flavocoxid and citrated zinc bisglycinate) 500 mg/50 mg capsules,... Marketed Without An Approved NDA/ANDA: Based on the labeling claims, these products are unapprove... Class I Primus Pharmaceuticals, Inc.
Jan 25, 2018 PD-Rx Pharmaceuticals Incorporated Ibuprofen 200 mg tablets a) 24 tablets NDC... CGMP deviations. Class II PD-Rx Pharmaceuticals, Inc.
Jan 24, 2018 Cefuroxime, Ophthalmic Solution for Injection, 10 mg/mL, 0.3 mL single-use sy... Subpotent Drug: The product is sub-potent prior to its 90-day beyond use date. Class III JCB Laboratories LLC
Jan 24, 2018 Life Brand Clear Action Acne Treatment Concealer Stick (Salicylic acid), 1.9g... Superpotent drug: failed assay throughout the stick after 6 months stability. Class III Oxygen Development Llc
Jan 22, 2018 Oxycodone Hydrochloride Tablets, USP 15 mg, 100 count bottles, Rx only, Manuf... Labeling; Label Error Not Elsewhere Classified; label missing controlled substance CII symbol Class III Ascent Pharmaceuticals, Inc.
Jan 22, 2018 Ultane (sevoflurane), 250 mL, Inhalation Anesthetic, Rx only, Manufactured by... Defective container: presence of a hole in the liners of the caps covering the product bottle, in... Class III AbbVie Inc.
Jan 22, 2018 Mycamine (micafungin) for Injection 100 mg/vial Single-Dose Vial Rx only Mar... Labeling: Label Error on Declared Strength Class II Astellas Pharma US Inc
Jan 19, 2018 Ling Zhi capsules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 TP Drug Laboratories Vitamin C ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Relumins Vitamin C Solvent ampules Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Tationil Glutathione, 600 mg/ 4 mL, polvere e solvente per soluzione iniettab... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Relumins Advanced Glutathione kits, 900 mg vials, 1500 mg vials and 3000 mg v... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Tatiomax Gluatathione Whitening kits, 1400mg vials, Made in Japan Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Ciclopirox Olamine Cream USP, 0.77%, packaged in a) 15 g tubes (NDC 0713-0638... Discoloration: Product is supposed to be a white to off white homogenous cream and may have inter... Class III G & W Laboratories, Inc.
Jan 19, 2018 Laennec INJ, Placenta extract (human), 2mL vials, Manufactured by: GCJBP Corp... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Reiki Glutathione Whitening kits Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Aripiprazole Tablets, USP, 10 mg, 100 Tablets (10 x 10) unit dose blisters [N... CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... Class II AMERICAN HEALTH PACKAGING
Jan 19, 2018 Laroscorbine Platinum Vitamin C 1 gm Collagen 0.35 gm, Roche Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 TAD Glutathione Whitening Kits lyophilized powder for injection, 600 mg vials... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Saluta Glutathione Whitening kits, packaged in 600 mg, 1200 mg and 1800 mg g... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty LLC
Jan 19, 2018 Sterilized water for injections BP, 50 x 5 mL plastic ampules, Manufactured i... Marketed Without An Approved NDA/ANDA: Flawless Beauty, LLC is voluntarily recalling all lots of ... Class II Flawless Beauty 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.