Browse Drug Recalls

17,874 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 17,874 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 17,874 FDA drug recalls.

DateProductReasonClassFirm
Jun 23, 2022 FW ASPIRIN CHEWABLE TABLET 36CT SKU 913990 GS ENTERIC ASPIRIN TABLET 120 CT ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 BLISTEX LIP MEDEX 0.25OZ SKU 906120 BLISTEX LIP MEDEX POT 0.38 OZ SKU 99885... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ORAJEL GUM PAIN RELIEF GEL 0.125OZ SKU 903432 GOOD SENSE ORAL PAIN RELIEF 0... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 AMBI Skin Cream for normal skin 2 OZ SKU 2024219 AMBI Skin Cream for oily s... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 STYE EYE OINTMENT 0.125 OZ distributed to specific Family Dollar Stores 04/30... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 Listerine Cool mint Mouthwash 250 mL SKU 900733 Crest Scope Outlast Mint Mou... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 FS CLOTRIMAZOLE ANTI FUNGAL CREAM .5 OZ distributed to specific Family Dollar... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 Hydrogen Peroxide 16 fl. oz. and 32 oz. bottles distributed to specific Famil... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 MYLICON INFANT GAS DROPS 0.5 OZ distributed to specific Family Dollar Stores ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GUARDIAN BISMUTH CHWBLE CHRY TABS 30 CTSKU 902321 RIC BISMUTH MAXIMUM STREN... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 VASELINE ECZEMA CALMING THERPY CRM 6.8 OZ distributed to specific Family Doll... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 HYLANDS 4KIDS COLD N MUCUS RELIEF 4 FL OZ distributed to specific Family Doll... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DISNEY LICENSED ANTI BAC WIPES 20 CT SKU 998908; ANTIBACTERIAL WIPES 40CT S... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GOOD SENSE OMEPRAZOLE TABLET 14CT SKU 900055 PRILOSEC OTC TABLET 14 CT SKU... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GOOD SENSE ESOMEPRAZOLE ACID REDUCER 20MG 42CT distributed to specific Famil... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 JOHNSONS BABY FIRST TOUCH GIFT SET 4PC distributed to specific Family Dollar ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 BC ARTHRITIS PAIN FAST PAIN RELIEF 24CT SKU 999839 GOOD SENSE ARTHRITIS CAP... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 MOTRIN IB CAPLETS 24CT SKU999394; GOOD SENSE IBUPROFEN 200MG TABLETS 24CT SKU... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 READY IN CASE CTRZNE ALRGY ALL DY TBLT 5 CT SKU 900448 ZYRTEC CHILDRENS GRA... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 MY CHOICE LEVONORGESTREL TABLET distributed to specific Family Dollar Stores ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 QP DPHNHDRME ALRGY MIN TBLT 12 CT SKU 900449 QP ALLERGY DIPHENHYDRAMINE 25 M... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GC MILK OF MAGNESIA CHERRY 12 FL OZ SKU 915000 GC MILK OF MAGNESIA MINT 12 ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ACNE FREE ADAPALENE GL ACN TRTMT 0.5 OZ SKU 2096518 ACNE FREE TRMINTR 10 SP... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ORAJEL NON MED TEETHING GEL 0.125 OZ distributed to specific Family Dollar St... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GOOD SENSE LICE SHAMPOO 6FL OZ distributed to specific Family Dollar Stores 0... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ZARBEES NTRLS BABY CGH MUCUS GRP 2 FL OZ distributed to specific Family Dolla... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 ALEVE ANALGESIC BACK MUSCLE 24 CT SKU 999787 ALEVE PM CAPLETS 20 CT SKU 900... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 READY IN CASE RUBBING ALCHL 50 PCT WNTRGRN 16 FLOZ distributed to specific Fa... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 SUAVE INV SLD PWDR 1.2 OZ SKU2004504 SUAVE AP INV SOLID SWEET PEA 1.2 OZ SK... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 DOCTOR TEALS PURE EPSOM SALT UNSCENTED 6 LBS SKU 999355 Ready in case EPSOM... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 AD PREV OINT ORIG 4 OZ distributed to specific Family Dollar Stores 04/30/202... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 GOOD SENSE HEMORRHOID OINTMENT 2 OZ SKU 910325 GOOD SENSE HEMORRHOIDAL WIPE... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 Dermasil Dry Skin Treatment 10 OZ SKU 2098068 Aveeno Daily Moisturizing Loti... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 23, 2022 VOLTAREN ARTHRITIS PAIN GEL 20G distributed to specific Family Dollar Stores ... CGMP Deviations: product held outside appropriate storage temperature conditions. Class II Family Dollar Stores, Llc.
Jun 21, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP 20mg, Rx Only, 90 Capsul... Superpotent Drug: Out of specification for assay at the 12-month timepoint. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 21, 2022 Testosterone Cypionate Injection, USP, 200mg/mL, CIII, Rx only, 1mL Single-d... cGMP - Water leakage Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 21, 2022 Esomeprazole Magnesium Delayed-Release Capsules, USP, 40mg, Rx Only, 90 Capsu... Superpotent Drug: Out of specification for assay at the 12-month timepoint. Class III SUN PHARMACEUTICAL INDUSTRIES INC
Jun 17, 2022 Morphine Sulfate extended-Release Tablets, USP; 60 mg, 100-count bottles, Rx ... Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... Class I Bryant Ranch Prepack, Inc.
Jun 17, 2022 Morphine Sulfate extended-Release Tablets, USP; 30 mg, 100-count bottles, Rx ... Labeling: Label Mix-up: bottles labeled as Morphine Sulfate 60 mg Extended-Release tablets conta... Class I Bryant Ranch Prepack, Inc.
Jun 16, 2022 Eszopiclone Tablets, USP 1 mg, packaged in 30-count bottles, Rx Only, Manufa... Shortfill: customer complaints of one to three tablets were reported missing from 30 count bottles. Class II Macleods Pharma Usa Inc
Jun 16, 2022 Mometasone Furoate, Topical Solution USP, 0.1 % Lotion, a) 30 ml-bottle (NDC ... Defective Container Class III Glenmark Pharmaceuticals Inc., USA
Jun 16, 2022 Draximage MAA (Kit for the preparation of Technnetium Tc 99m Albumin Aggregat... Lack of Assurance of Sterility: Out-of-specification test results obtained for Endotoxin testing. Class II Jubilant Draximage Inc
Jun 15, 2022 70% ISOPROPYL ALCOHOL First aid antiseptic, 4 FL OZ (118 mL) bottle, Made in ... Defective Container: Product may leak when squeezed or when not in an upright position determined... Class II Vi-Jon, LLC
Jun 14, 2022 Tretinoin Capsules, 10 mg, Rx Only, 100 capsules per bottle, Teva Pharmaceuti... Failed Dissolution Specifications; Low Out of Specification (OOS) results for dissolution. Class II Teva Pharmaceuticals USA Inc
Jun 13, 2022 CVS Health Magnesium Citrate SALINE LAXATIVE, Oral Solution, 1.745 g, Lemon F... Microbial Contamination of a Non-Sterile Products: Testing of product onfirmed the presence of G... Class I Vi-Jon, LLC
Jun 13, 2022 Fluticasone Propionate Nasal Spray, USP, 50 mcg, 16 g net fill weight per amb... Defective container: defect prevents product from dispensing as intended. Class II Akorn, Inc.
Jun 10, 2022 Testosterone Cypionate Injection, USP, 200 mg/mL, 1 mL Single-dose vial per c... Lack of Assurance of Sterility: Manufacturing deviation which was reported due to a microbial exc... Class II SUN PHARMACEUTICAL INDUSTRIES INC
Jun 10, 2022 Doxycycline (as Calcium) (equivalent to 50mg/5mL), 10 mg/ml, 60 ml suspension... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 10, 2022 Estriol 1mg/gm, Vaginal Cream, 60 gm tube, Qty: 1, Wedgewood Village Pharmacy... Lack of Processing Controls: Insanitary conditions observed during recent FDA Inspection Class II Wedgewood Village Pharmacy, LLC
Jun 10, 2022 Zileuton Extended-Release Tablets, 600 mg, 120-count bottle, Rx only, Manufac... Failed Dissolution Specifications: Out of specification test results observed in dissolution test... Class II Lupin Pharmaceuticals 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.