Browse Drug Recalls
6,274 FDA drug safety recalls.
FDA Drug Recall Enforcement Database
Browse 6,274 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 6,274 FDA drug recalls.
| Date | Product | Reason | Class | Firm |
|---|---|---|---|---|
| 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 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 |
| Dec 15, 2016 | AMGEN Kyprolis (carfilzomib) for injection, 30 mg per vial, Discard unused p... | Lack of Assurance of Sterility: Potential cracks in glass vials | Class II | Amgen, Inc. |
| Dec 15, 2016 | Phenylephrine 2.5% + Tropicamide 1% Compounded Eye Drops Solution, 5 mL bot... | Lack of Sterility Assurance | Class II | Meta Pharmacy Services |
| Dec 13, 2016 | Nano PNC Water, packaged in amber glass bottles, Rx only, ICRPstudy.com, Immu... | Marketed without an Approved NDA/ANDA and non-sterility: NANO PNC Water by nebulizer was sampled... | Class I | Pacific Medical Solutions |
| Dec 6, 2016 | Fluconazole Injection, USP, 200 mg/100 mL (2mg/mL), 100 mL Single-Dose Intrav... | Lack of Assurance of Sterility: confirmed customer complaints of leaking bags. | Class II | Baxter Healthcare Corporation |
| Nov 18, 2016 | Lidocaine HCl 1%, 10 mL Syringe, Hospital/Office Use Only, Rx Only, Cantrell ... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Oxytocin 30 USP Units Added to 0.9% Sodium Chloride, 500 mL Bag, Single-Dose ... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Calcium Chloride, (1 g/10 mL) Injection Solution 10 mL, 10% Single-Dose Vial,... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | HYDROmorphone HCl 50 mg/50 mL in 0.9% Sodium Chloride (1 mg/mL) Single-Dose S... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Fentanyl Citrate 2,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 250 mL* Bag, S... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Heparin Sodium, 1 USP Unit/2 mL (0.5 USP Units/mL) in 0.45% Sodium Chloride, ... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Fentanyl Citrate 1,500 mcg in 0.9% Sodium Chloride (10 mcg/mL) 150 mL Bag, Si... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | HYDROmorphone HCl 6 mg/30 mL in 0.9% Sodium Chloride (0.2 mg/mL) Single-Dose ... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Ropivacaine HCl 0.25% in 0.9% Sodium Chloride, 100 mL Bag, Epidural Use Only,... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
| Nov 18, 2016 | Succinylcholine Chloride 200 mg/10 mL Injection Solution 10 mL (20 mg/mL) ,Si... | Lack of Assurance of Sterility - the firm is recalling select sterile drug products. | Class II | Cantrell Drug Company |
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.