Browse Drug Recalls
17,897 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 17,897 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 17,897 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 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 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 | 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 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 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 | 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 |
| 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 17, 2018 | Senna Laxative (sennosides) tablets, 8.6 mg, 100-count bottles, Manufactured ... | Labeling: Label Mix-Up: Customer complaint received that a bottle labeled as Senna Laxative conta... | Class I | Magno Humphries Laboratories, Inc |
| Jan 16, 2018 | Vecuronium bromide for Injection, 10 mg vials, Rx only, Mfd. for: Fresenius K... | Failed impurities/ degradation specifications: Out-of-specification (OOS) result for USP related ... | Class III | Fresenius Kabi USA, LLC |
| Jan 16, 2018 | DOXOrubicin Hydrochloride Liposome Injection, 20 mg/10 ml (2 mg/mL), 10 mL Si... | Lack Of Assurance Of Sterility | Class II | Sun Pharmaceutical Industries, Inc. |
| Jan 12, 2018 | Pravastatin Sodium Tablets, USP, 10 mg, 30-count bottles, packaged in 12 x 30... | Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... | Class II | International Laboratories, Inc. |
| Jan 12, 2018 | Pravastatin Sodium Tablets, USP, 20 mg, 30-count bottles, packaged in 12 x 30... | Presence of Foreign Tablets/Capsules: bottles could contain both pravastatin sodium 10 mg and 20 ... | Class II | International Laboratories, Inc. |
| Jan 12, 2018 | HCG 5,000 IU/mL + Methylcobalamin 500 mcg/mL Injection 5 mL, Multi-Dose Vial,... | Non-Sterility | Class I | The Compounding Pharmacy of America |
| Jan 12, 2018 | Levofloxacin in 5% Dextrose Injection, 250 mg/50 mL (5 mg/mL), 50 mL Single-U... | Presence of Particulate Matter; contains visible particulate matter identified as mold. | Class I | AuroMedics Pharma LLC |
| Jan 11, 2018 | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 ta... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 table... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplet... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Dist... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Mitomycin 40 mg/mL Preservative Free Irrigation Volume: 10 mL SDV , Compounde... | Labeling: Label Error on Declared Strength | Class II | Premier Pharmacy Labs Inc |
| Jan 11, 2018 | Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tab... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tabl... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 11, 2018 | Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplet... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Time-Cap Laboratories, Inc. |
| Jan 10, 2018 | Ibuprofen Tablets USP, 200 mg, 100-count bottles, OTC, Distributed By: Spirit... | CGMP deviations: Ibuprofen is being recalled in response to previous recall | Class II | Spirit Pharmaceuticals, LLC |
| Jan 10, 2018 | Aripiprazole Tablets, USP, 10 mg, 30-count bottles, Rx Only, Manufactured fo... | CGMP Deviations: lot made with active pharmaceutical ingredient that did not meet all its intende... | Class II | Hetero Labs, Ltd. - Unit III |
| Jan 9, 2018 | Ibuprofen Tablets, USP 600 mg, 6 x 2500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Caplets (Capsule-Shaped Tablets) bulk... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 800 mg, 6 x 1900 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma Inc. |
| Jan 9, 2018 | Ibuprofen Tablets, USP 200 mg, 6 x 6500 Tablets bulk packed in double polybag... | CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complai... | Class II | Marksans Pharma 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.