Browse Drug Recalls

1,680 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 1,680 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 1,680 FDA drug recalls — Class III.

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Date	Product	Reason	Class	Firm
Oct 1, 2019	Sankaijo BOTANICAL LAXATIVE (docusate sodium 8.33 mg and sennosides 1.36 mg) ...	Subpotent Drug: Formulated amount of sennosides component is less than labelled claim.	Class III	Sato Pharmaceutical Inc.
Oct 1, 2019	Motion Sickness Strips (meclizine hydrochloride) 25 mg strips, 8-count box, D...	Subpotent Drug	Class III	Sato Pharmaceutical Inc.
Oct 1, 2019	Zentrip (meclizine Hydrochloride), 25 mg strips, 8-strips per box, Distribute...	Subpotent Drug	Class III	Sato Pharmaceutical Inc.
Sep 27, 2019	Testosterone Cypionate Injection, USP, 2000 mg/10 mL, 1 mL Vial, Single-Dose,...	Labeling:Label Mix-up: Shipper Carton labelled Testosterone Cypionate Injection, USP, 200mg/mL, 1...	Class III	Arbor Pharmaceuticals Inc.
Sep 24, 2019	Benazepril HCl Tablets, USP 40 mg, 100 count bottles, Rx only, Distributed by...	Presence of Foreign Tablet/Capsule; Promethazine HCl tablet found in the Benazepril HCl bottle	Class III	Amneal Pharmaceuticals, Inc.
Sep 23, 2019	Ranitidine Tablets USP,150 mg, 8-count bottles, Distributed by: Dolgencorp,...	CGMP DEVIATIONS: One lot of Ranitidine Tablets USP, 150 mg is being recalled because some bottles...	Class III	AuroMedics Pharma LLC
Sep 13, 2019	Sodium Chloride Injection USP 0.9%, packaged in 1 - 125 mL Ultraject Prefille...	Labeling: Not Elsewhere Classified: RFID formatting error which reads product in Ultraject syring...	Class III	GUERBET LLC
Sep 12, 2019	Zarontin (ethosuximide capsules, USP) 250 mg, 100-count bottle, Rx Onl,y Made...	Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco...	Class III	Pfizer Inc.
Sep 12, 2019	ethosuximide capsules, USP, 250 mg, 100-count bottle, Rx Only, Distributed by...	Labeling: Incorrect or Missing Lot and/or Exp Date. The expiry date on the product label is inco...	Class III	Pfizer Inc.
Sep 6, 2019	Matzim LA (Diltiazem Hydrochloride) Extended-Release Tablets, 240 mg, 30 coun...	GMP Deviation: lot not intended for commercial distribution.	Class III	Teva Pharmaceuticals USA
Sep 6, 2019	Gatifloxacin Ophthalmic Solution 0.5%, 2.5 mL per bottle, Rx Only, Mfd. for: ...	Failed Impurities/Degradation Specifications:OOS for unknown impurity.	Class III	Mylan Pharmaceuticals Inc.
Aug 27, 2019	Lamivudine Tablets, USP, 150 mg, 30 (3x10) count Unit Dose Blisters Carton, N...	Labeling: Incorrect or Missing Package Insert; an error in the Dosage Forms and Strengths secti...	Class III	American Health Packaging
Aug 26, 2019	minolira (minocycline hydrochloride) extended-release tablets 135 mg* Physici...	Failed Dissolution Specifications:	Class III	EPI Health, LLC
Aug 21, 2019	Pramipexole Dihydrochloride Tablets 0.125 mg,90-count bottle, Rx Only, Manufa...	Subpotent Drug: Out of specification result during stability study in Pramipexole Dihydrochloride...	Class III	Macleods Pharma Usa Inc
Aug 7, 2019	Clotrimazole and Betamethasone Dipropionate Cream USP, 1%/0.05%, 15 gram tube...	Temperature Abuse: Complaints received of liquidy texture.	Class III	Glenmark Pharmaceuticals Inc., USA
Aug 6, 2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo...	Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) an...	Class III	Akorn, Inc.
Aug 6, 2019	Eptifibatide Injection, 75 mg/100 mL (0.75 mg/mL), 100 mL Single-use Vial, Fo...	Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as...	Class III	Akorn, Inc.
Aug 6, 2019	Eptifibatide Injection, a) 20 mg/10 mL (2 mg/mL),10 mL Single Use Vial, NDC 1...	Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-as...	Class III	Akorn, Inc.
Jul 29, 2019	Simvastatin Tablets, USP 40 mg. Rx Only 1000 Count Bottles Manufactured by: A...	Labeling; Incorrect or Missing Lot and/or Exp Date; some bottles labeled with lot number 05318054...	Class III	Aurobindo Pharma USA Inc.
Jul 18, 2019	Methylergonovine Maleate USP 0.2 mg Tablets a) 12 count (NDC 69238-1605-02) ...	Presence of Foreign Tablet/Capsule; one Promethazine tablet was found in a bottle of Methylergono...	Class III	Amneal Pharmaceuticals, Inc.
Jul 17, 2019	Nystatin and Triamcinolone Acetonide Cream USP100,000 units/g, 0.1%, 15 g tub...	Failed Content Uniformity Specifications: Out-of-specification result observed in uniformity of c...	Class III	Lupin Pharmaceuticals Inc.
Jul 11, 2019	Gatifloxacin Ophthalmic Solution 0.5%, For Use in the Eyes Only, Rx Only, Ste...	Labeling: Missing label; Product complaints reported missing bottle label.	Class III	Lupin Pharmaceuticals Inc.
Jun 25, 2019	Smart Sense Regular Strength Aspirin Tablets, 325 mg packed in a) 100 count U...	Labeling; Incorrect or Missing Lot Number and/or Exp Date; Product has an incorrect expiration da...	Class III	AAA Pharmaceutical, Inc.
Jun 17, 2019	Lotemax (loteprednol etabonate ophthalmic gel 0.5%), Sterile, Rx Only, 5 g bo...	Failed Stability Specifications: Out of specification for viscosity.	Class III	Bausch & Lomb
Jun 12, 2019	Testosterone Topical Solution 30mg of testosterone per pump actuation * each ...	Defective Container; actuator may improperly function and affect dose delivery.	Class III	InvaGen Pharmaceuticals, Inc.
Jun 7, 2019	Myorisan (isotretinoin capsules, USP), 40 mg, packaged in cartons of 30 Capsu...	Labeling: Label mix-up: Product secondary carton erroneously states 40mg instead of 30 mg, primar...	Class III	Akorn Inc
May 22, 2019	Ondansetron Injection, USP, 40 mg / 20 mL, 20 mL vial, Rx Only, Fresenius Kab...	Failed Impurities/Degradation Specifications.	Class III	Fresenius Kabi USA, LLC
May 20, 2019	Betamethasone Dipropionate Ointment USP, 0.05%* (Augmented), a) 15 gram (NDC ...	Failed Impurities/Degradation Specifications	Class III	Teligent Pharma, Inc.
May 10, 2019	QUIK-CARE Aerosol Foam Hand Sanitizer (62.5% Ethyl Alcohol), packaged in 7 oz...	Incorrect/undeclared excipients: Hand sanitizer was made using the wrong alcohol raw material.	Class III	Ecolab Inc
Apr 29, 2019	Relpax (eletriptan HBr) 40 mg, a) 12 tablets 2 cards x six 40 mg tablets per ...	Labeling: Label Error on Declared Strength: an artwork error on the secondary packaging of Relpax...	Class III	Pfizer Inc.
Apr 25, 2019	Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2...	Labeling: Not Elsewhere Classified: canisters incorrectly state the net weight is 2.75 oz. rathe...	Class III	Advantice Health
Apr 25, 2019	Dermoplast Anesthetic PAIN & ITCH (benzocaine and menthol) SPRAY canisters, 2...	Labeling: Not Elsewhere Classified: Full cases may contain canisters that incorrectly state the n...	Class III	Advantice Health
Apr 23, 2019	Fentanyl Citrate Injection, USP, 100 mcg/2 mL (50 mcg/mL), 25 Ampules per car...	Failed impurities/degradation specification: Out of Specification result for total impurity at 4....	Class III	Akorn Inc
Apr 22, 2019	Carvedilol Tablets, USP, 3.125 mg, 500-count bottle, Rx Only, Manufactured by...	Presence of Foreign Tablets/Capsules: Customer complaint for a small, solid, light yellow substan...	Class III	Zydus Pharmaceuticals USA Inc
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 100 mg, 100-count bottles, Rx Only...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 200 mg Rx Only 100 Tablets Manufac...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 15 mg, 100-count bottles, Rx Only,...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 30 mg, 100-count bottles, Rx Only,...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 10, 2019	Morphine Sulfate Extended-Release Tablets, 60 mg, 100-count bottles, Rx Only,...	Failed Impurities/Degradation Specifications	Class III	LUPIN SOMERSET
Apr 3, 2019	Telmisartan and Amlodipine Tablets 80 mg/5 mg, 30 tablets, Rx Only, Manufact...	Failed Impurities/Degradation Specifications; 18 month long term stability study (manufacturer)	Class III	AVKARE Inc.
Apr 2, 2019	Remifentanil HCl active pharmaceutical ingredient (API) for manufacturing, pr...	Failed Impurities/Degradation Specifications: Unknown impurity above specification limits.	Class III	Johnson Matthey Inc.
Apr 1, 2019	festpak clearly fun SPF30 sunscreen lotion SPF 30 SUNSCREEN LOTION Active Ing...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	ICEE BLUE RASPBERRY SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 ...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	AMERICA'S ORIGINAL DUBBLE BUBBLE Pink Lemonade SCENTED ANTIBACTERIAL HAND GEL...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	TOOTSIE ROLL SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%), 1.35 fl oz /...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	Accent Care of New York Home Care Nursing Personal Care Hand Sanitizer (Ethyl...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	CHARMS BLOW POP SOUR APPLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 62%)...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	TOOTSIE ROLL FRUIT CHEWS LEMON SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol ...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	TOOTSIE ROLL FRUIT CHEWS LIME SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcohol 6...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.
Apr 1, 2019	AMERICA'S ORIGINAL DUBBLE BUBBLE SCENTED ANTIBACTERIAL HAND GEL (Ethyl Alcoho...	CGMP deviations: Stability testing was not conducted on manufactured sunscreen and hand sanitizer...	Class III	NingBo Huize Commodity Co.,Ltd.

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.