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.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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.