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Browse Drug Recalls

1,141 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,141 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 1,141 FDA drug recalls in 2017.

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DateProductReasonClassFirm
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 10, 2017 GENTLE BLEACHING CREAM (Retinoic Acid 0.025, Kojic Acid 3%,Hydrocortisone 1%)... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TRI-BLEACHING CREAM HQ (retinoic Acid 0.05%, Hydroquinone 6%, Fluocinolone 0.... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SALICYLIC ACID SOLUTION in all strengths including 20%, 25%, 30%, and 40%, ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ACNE SOLUTION (Salicylic acid 2%, Hydrocortisone 2%, Niacinamide 4%, Azelaic ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 METRONIDAZOLE 1% GEL, METRONIDAZOLE 1%/ NIACINAMIDE 4%/ AZELAIC CREAM 10% CRE... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 FLUORORACIL 0.05% CREAM, FLUORORACIL 5% CREAM, FLUOROURACIL 4.9% IN CERAVE CR... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BRIGHTENING CREAM (Retinoic acid 0.1%, Hydroquinone 4%, kojic acid 3%, hydroc... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLINDAMYCIN 1%, AZELAIC ACID 10% CREAM, CLINDAMYCIN 1.2%/ TRETINOIN 0.05% GEL... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MALEK'S MAGIC PLUS (retinoic acid 0.1%, hydroquinone 6%, kojic acid 3%, hydro... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BENZOYL PEROXIDE 5% CLINDAMYCIN 1.2%, Rx only, Synergy RX, 4901 Morena Blvd #... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ERYTHROMYCIN 2% IN CERAVE CREAM, ERYTHROMYCIN 3% / RETINOIC ACID 0.05%, Rx on... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LACTIC ACID SOLUTION in all strengths including 20%, 30%, and 60%, Rx only, S... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BL 20%/4% CREAM, BLT 20%/6%/4% CREAM, BLT 20%/6%/6%, BLT 20% 8% 4% CREAM, BLT... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 GLYCOLIC ACID SOLUTION, all strengths including 10%, 20%, 30%, 50%, and 60%, ... 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 8%, Fluocinolone 0.01%... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 FLUOCINONIDE 0.05% SOLUTION, Rx only, Synergy RX, 4901 Morena Blvd # 504-A Sa... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CALMING CREAM (Hydrocortisone 2.5%, Aloe vera powder), Rx only, Synergy RX, 4... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MINOXADIL all strength including 2%, 5% and MINOXIDIL / RETINOIC ACID 5% / 0.... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HUMAN CHORIONIC GONADOTROPIN in 300IU and 500 IU TABLETS, Rx only, Synergy RX... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 LIDOCAINE CREAM in all strengths including: 5%, 8%, 23%, 30%, LIDOCAINE / P... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 CLEAR (Benzoyl Peroxide 3.75%, Clindamycin 1.2% Gel), Rx only, Synergy RX, 49... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 HI-LITE Cream (Retinoic Acid 0.05%, Hydroquinone 4%, Fluocinolone 0.01%), Rx ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 MODIFIED JESSNER PEEL (Sal Acid 14%, Lactic Acid 14%, glycolic 14%), Rx only,... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 SUPREME CREAM (Retinoic acid 0.05%, hydroquinone 6%, kojic acid 3%, Alpha Arb... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETINOIC ACID all strengths including 0.025%, 0.05% and 0.1% CREAM, RETINOIC ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 BICARBONATE 10%, Rx only, Synergy RX, 4901 Morena Blvd # 504-A San Diego, CA ... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 ADAPALENE 0.1%, BENZOYL PEROXIDE 2.5% GEL, ADAPELENE 0.3%, BENZOYL PEROXIDE 2... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 RETINOIC ACID SOLUTION in all strengths including 0.3%, 0.4%, 0.5%, 1%, RETIN... Lack of Assurance of Sterility: There are also CGMP Deviations. Class II Synergy Rx
Feb 10, 2017 TCA PEEL SOLUTION in all strengths including: 5%, 10%, 15%, 18%, and 20%, TCA... 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 8, 2017 Ibuprofen Lysine Injection, 20 mg/2 mL (10 mg/mL), 2 mL Single-Dose Vial (NDC... Presence of Particulate Matter Class I X-Gen Pharmaceuticals Inc.
Feb 7, 2017 Levofloxacin Ophthalmic Solution, 0.5%, Sterile, packaged in 5mL bottles, Rx... Failed Impurities/ Degradation Specifications: OOS for related compound (levofloxacin n-oxide) at... Class III Actavis Inc
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 Vancomycin HCl 750 mg added to 250 mL 0.9% Sodium Chloride For IV Use Only, R... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.25 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Onl... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.5 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
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 3, 2017 Vancomycin HCl 750 mg added to 5% Dextrose 250 mL For IV Use Only, Rx Only, S... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1 g added to 0.9% Sodium Chloride 250 mL Bag For IV Use Only, ... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
Feb 3, 2017 Vancomycin HCl 1.5 gram added to 5% Dextrose 500 mL Total Approximate Volume ... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
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 Vancomycin HCl 1.25 g added to 5% Dextrose 250 mL Bag For IV Use Only, Rx Onl... Presence of particulate matter - this recall is due to a recent Hospira recall of vancomyicn hydr... Class I SCA Pharmaceuticals
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

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.