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.

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DateProductReasonClassFirm
Feb 10, 2017 MALEK'S MAGIC (retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, hydrocort... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BLEACHING CREAM 0.1% CREAM, BLEACHING CREAM HQ4%, BLEACHING CREAM-NO HQ, Rx o... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROQUINONE SOLUTION in all strengths including 4%, 28%, Rx only, Synergy ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRICHLOROACETIC ACID SOLUTION in all strengths including: 10%, 12%, 15 %, 20... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LTP (Lidocaine 10%, Tetracaine 2%, Phenylephrine 0.5%), Rx only, Synergy RX, ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLEAR 2 (Benzoyl Peroxide 2.5%, Clindamycin 1.2% ), Rx only, Synergy RX, 490... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 Human Chorionic Gonadotropin (HCG) 5,000 units/vial and 11,000 units/vial, R... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CANTHARADIN 0.7% SOLUTION and CANTHARIDAN / PODOPHYLLUM SOLUTION, CANTHARI... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 METRONIDazole Injection, USP 500 mg (5 mg/mL) in 100 mL Single Dose Flexible ... Lack of Sterility Assurance: customer report of leaking bag Class II Hospira Inc., A Pfizer Company
Feb 10, 2017 ENHANCED RETIN ANTI-WRINKLE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 50... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HCG and HCG with resveratrol Human Chorionic Gonadotropin in different streng... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 FIRM AND FADE (Retinoic Acid 0.05%, Hydroquinone 6%, Kojic Acid 3%, Hydrocort... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRETINOIN CREAM in all strengths including: 0.1%, 0.05%, TRETINOIN GEL in al... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SUPREME BLEACHING CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GENERIC VI PEEL (Sal Acid 2%, TCA 7% Phenol 7%, Retinoic Acid 0.4%), Rx only,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETIN-A 0.05% CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BETAMETHASONE 0.25%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 QUAD BLEACHING CREAM (retinoic acid 0.05%, hydroquinone 6%, kojic aid 3%, hyd... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 KETOCONAZOLE 2%/HYDROCORTISONE 1.5% CREAM, Rx only, Synergy RX, 4901 Morena B... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 JESSNERS PEEL (salicylic Acid 14% rescorcinol 14%, Lactic acid 14%), Rx only,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 QUAD PEEL (Sal Acid 2%, TCA 7%, Phenol 7%, Retinoic acid 0.4%), Rx only, Syne... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MELATONIN 1.5MG SPRAY, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Dieg... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TACROLIMUS 0.1% Ointment and TACROLIMUS 0.1%/KETOCONAZOLE 2%, Rx only, Synerg... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 DICLOFENAC 3% and 5% LIP BALM and DICLOFENAC 5% SPF 30 LIP BALM, Rx only, Syn... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HYDROQUINONE CREAM in all strengths including: 4%, 5%, 6%, 7%, 8%,10%, Rx onl... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRI-BLEACHING CREAM (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 5-FLUOROURACIL IN VANICREAM, FLUOROURACIL in all strengths including 0.05%, 5... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 VI PEEL (Sal Acid 2%, TCA 17%, Phenol 7%, Retinoic Acid 0.4%), Rx only, Syner... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GLYCOLIC ACID 15% LOTION, GLYCOLIC ACID 20% GEL, GLYCOLIC ACID 6% LOTION, GLY... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRETINOIN 0.02% IN OIL FREE CREAM, Rx only, Synergy RX, 4901 Morena Blvd # 50... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 PURIFIED WATER, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA 9... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 8, 2017 CycloSPORINE Capsules, USP, 100 mg, 30 count (5x6) blister cartons, Rx only, ... Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... Class II Amerisource Health Services
Feb 7, 2017 Glipizide 2.5 mg ER Tablets, Manufactured by Watson Laboratories, Inc., Parsi... Failed Dissolution Specifications Class II RemedyRepack Inc.
Feb 7, 2017 Indocin (Indomethacin) suppositories, USP, 50 mg, laminate strips packed in b... Failed Impurities/Degradation Specifications: Out of specification (OOS) for total impurity and ... Class II G & W Laboratories, Inc.
Feb 7, 2017 Buprenorphine and Naloxone Sublingual Tablets 8 mg/2 mg, 30 count HDPE bottle... Failed Impurities/Degradation Specifications Class II Teva Pharmaceuticals USA
Feb 3, 2017 CycloSPORINE Capsules, USP, 100 mg, 30 count bottle, Rx Only, Manufactured by... Failed Impurities/Degradations Specifications; out of specification results for Maximum Unknown I... Class II Apotex Inc.
Feb 3, 2017 GlipiZIDE Extended-release tablets, 2.5 mg, 30-count carton (NDC 68084-295-21... Failed dissolution specifications: Glipizide 2.5 mg ER Tablets exceeded dissolution specificati... Class II Amerisource Health Services
Feb 2, 2017 Mimvey Lo (estradiol and norethindrone acetate tablets USP), 0.5 mg/0.1 mg, 2... Failed Impurities/Degradation Specifications: out of specification test results for the norethin... Class II Teva Pharmaceuticals USA
Feb 2, 2017 Transderm Scop (scopolamine) Transdermal System, 1.5 mg, 1 patch per pouch (N... Labeling: Incorrect Instructions:outer carton contains the incorrect instructions for Step 2 stat... Class II Sandoz Inc
Jan 30, 2017 Glipizide extended-release tablets, 2.5mg, 30-count bottle, Rx Only, Manufa... Failed Dissolution Specifications. Above out of specification for dissolution rate observed at th... Class II Actavis Inc
Jan 27, 2017 MakeSense PHARMA, HEMORRHOIDAL RELIEF CREAM Phenylephrine HCL-0.25% Zinc Oxid... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA Medicated ANTI-ITCH CREAM WITH SOOTHING ALOE VERA AND VITAMI... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM 1 oz. Miconazole Nitrate 2%, 1 oz. (28 g) t... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA ANTIFUNGAL CREAM Clotrimazole 1%, 1.25 oz. (35 g) tube, Mad... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 MakeSense PHARMA FIRST AID CREAM Lidocaine HCL 0.5%, Phenol 0.5%, 1 oz.. (28 ... CGMP Deviations Class II Cherry Hill Sales Co.
Jan 27, 2017 Mirtazapine Tablets, USP, 45 mg. Rx only, 100 Tablets (10 X 10). Manufactur... Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablets commingled Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
Jan 19, 2017 glipiZIDE Extended-Release Tablets, 5 mg, 1000 count bottles, Rx only, Mylan ... Presence of Foreign Tablets/Capsules; bottles of Glipizide 5 mg tablets may contain Glipizide 10 ... Class II Mylan Pharmaceuticals Inc.
Jan 19, 2017 Calcipotriene Cream 0.0005%, packaged in a) 60g tube, (NDC 66993-877-61), b) ... Incorrect/Undeclared excipients: inadvertent omission of a drug excipient from the the Authorized... Class II LEO PHARMA INC
Jan 19, 2017 Mirtazapine Tablets, USP 45 mg, a) 30 count, b) 100 count and c) 500 count bo... Presence of Foreign Tablets/Capsules; possibility of Glipizide 10 mg tablet in bottle Class II Mylan Pharmaceuticals Inc.
Jan 18, 2017 Metoclopramide Oral Solution, USP 10 mg/ 10 mL, 50 unit dose cups of 10 mL pe... CGMP Deviations: Purified water used to manufacture the drug products may have been contaminated ... Class II VistaPharm, 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.