Browse Drug Recalls

18,041 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 18,041 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 18,041 FDA drug recalls.

DateProductReasonClassFirm
May 7, 2018 Hydrocortisone Ointment, USP 2.5%, Net Wt. 20g, Rx Only, Manufactured By Perr... Failed Stability Specifications Class II Perrigo New York
May 7, 2018 RPC Children's Non-Aspirin (Acetaminophen 160 mg) Elixir, packaged in 4 FL. O... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Liquid Pain Relief Acetaminophen Cherry Flavor 160mg/5mL, packaged i... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC Senna Syrup (Sennosides 8.8mg), packaged in 8 fl oz (237 mL) bottles, RIJ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Iron Supplement Elixir Ferrous Sulfate 220 mg, packaged in 16 fl oz.... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 RPC APAP Elixir (Acetaminophen 160mg), Packaged in 16 FL. OZ. (473 mL) bottle... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Preferred Plus Pharmacy Antacid (Aluminum Hydroxide 200mg, Magnesium Hydroxid... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 GeriCare Senna Syrup (Sennosides 8.8 mg), 8 fl oz (237 mL) bottles, Dist, by ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Ritussin DM Dextromethorphan Hydrobormide (Dextromethorphan HBr, USP 10 mg, G... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 SDA Senna Syrup (Sennosides 8.8mg), packaged in 8 FL. OZ. (236 mL) bottles, D... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 7, 2018 Gericare Diocto Liquid (Docusate Sodium 50mg), 50 mg/5 mL, packaged in 16 FL ... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
May 4, 2018 Zoma Shampoo, Zinc Pyrithione 1.92%, 300 ml/10.01 fl. oz. bottles, Dermatolog... Subpotent Class III Milbar Laboratories, Inc.
May 4, 2018 B Prox 10 Anti-blemish Wash, (Benzoyl peroxide 10%), 200 mL bottles, Dermatol... Microbial Contamination of Non-sterile Product Class II Milbar Laboratories, Inc.
May 4, 2018 Solar Defense Sheer Sunscreen Broad Spectrum SPF50 (Octinoxate 7.5%, Zinc Oxi... GMP Deviations Class II Milbar Laboratories, Inc.
May 4, 2018 T Shampoo For Hair and Body, Solution Coal Tar 3% (0.6% coal tar), 300 ml/10.... Subpotent Class III Milbar Laboratories, Inc.
May 4, 2018 MD Complete Clarifying Cleanser (Salicylic Acid 2.0%), 3 fl oz, (88.7mL), MD ... GMP Deviations Class II Milbar Laboratories, Inc.
May 4, 2018 Minivelle (estradiol transdermal system) 0.1 mg/day, 1 System per pouch (NDC ... Defective Delivery System: no longer meets the specification for shear, an attribute related to t... Class II Noven Pharmaceuticals, Inc.
May 4, 2018 Minivelle (estradiol transdermal system) 0.0375 mg/day, 1 System per pouch (N... Defective Delivery System: no longer meets the specification for shear, an attribute related to t... Class II Noven Pharmaceuticals, Inc.
May 4, 2018 Naturmetic SPF 50 Sunscreen (Octinoxate 7.5%, Zinc Oxide 10.5%), 2.0 fl oz/60... GMP Deviations Class II Milbar Laboratories, Inc.
May 1, 2018 Loxapine Capsules, USP 50 mg, packaged in 100 Unit Dose capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018 Loxapine Capsules, USP 25 mg, packaged in 100 Unit Dose Capsules, Rx only, Ma... GMP Deviations: a recent FDA inspection of the manufacturing site revealed multiple cGMP violatio... Class II Mylan Institutional, Inc. (d.b.a. UDL Laborator...
May 1, 2018 Ampicillin and Sulbactam for Injection, USP, 3 gram*s/vial, For Intramuscular... Presence of Particulate Matter: confirmed customer report of the presence of visible particulate ... Class I AuroMedics Pharma LLC
May 1, 2018 Piperacillin and Tazobactam for Injection, USP 3.375 grams per vial, For Intr... Presence of Particulate Matter: confirmed customer report for presence of visible particulate mat... Class I AuroMedics Pharma LLC
Apr 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 10 mg, Rx Only, 4... CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets, 30 mg, Rx Only,... CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 30, 2018 Lidocaine Patch 5% (700 mg) ,(NDC 0591-3525-11), 30 envelopes containing 1 pa... Failed Stability Specifications Class III Teva Pharmaceuticals USA
Apr 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, ... CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 27, 2018 Docetaxel injection concentrate, 20 mg/mL, 1 mL vial, Rx only, Winthrop U.S. ... Superpotent drug: over-concentrated vials of Docetaxel injection concentrate 20 mg/mL may have be... Class II Sanofi-Aventis U.S. LLC
Apr 26, 2018 Macroaggregated albumin (MAA) kit (for the preparation of Tc99m MAA), Aggrega... Lack of Assurance of Sterility Class II Coast Quality Pharmacy LLC
Apr 26, 2018 Riomet (metformin hydrochloride oral solution), 500 mg/5 mL (16 fl. oz.), 473... Labeling: Not Elsewhere Classified: Sun Pharma has decided to initiate this recall in response to... Class III Sun Pharmaceutical Industries, Inc.
Apr 24, 2018 Loxapine Capsules, USP 50 mg, Rx Only, 100-count bottles, NDC 0378-7050-01 CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Papaverine 9mg/Phentolamine 1mg/Atropine 0.1mg/Prostaglandinl 10mcg/ml, steri... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 30mg/Phentolamine 2mg/Prostaglandin 20mcg/mL, Papaverine 30mg/Phe... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Clindamycin 150 mg capsules, USP, 30-count M-Pak container. Mnfct by: Lannet... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Loxapine Capsules, USP 25 mg, Rx Only, 100-count bottles, NDC 0378-7025-01 CGMP Deviations Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Alprostadil 20 mcg/mL, Sterile injectable, Vitalab Pharmacy, Inc Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Clindamycin 300 mg capsules, USP, 28-count M-Pak containers, Rx Only. Mnfct f... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Methylcobalamin for injection, 1mg/mL and 10 mg/mL, Sterile injectable, Vital... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Papaverine 30mg/Phentolamine 1.5mg/Prostaglandin 50mcg/mL, sterile injectable... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Acetaminophen 300 mg with Codeine Phosphate 30 mg tablets, USP, 20-count M-Pa... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 24, 2018 Methionine 25mg/Inositol 50mg/Choline 50mg/Cyanocobalamin 1mg/ml, Sterile inj... Lack of assurance of sterility: Upon review of recent 3rd party environmental certification docum... Class II Vitalab Pharmacy, Inc
Apr 24, 2018 Amlodipine and Benazapril HCL Capsules, USP, 5 mg/40 mg, 100 count bottles, M... cGMP Deviations; cleaning processes for equipment used to manufacture the specified batches was n... Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Amlodipine and Benazapril HCL Capsules, USP, 5 mg/10 mg, 100 count bottles, M... cGMP Deviations; cleaning process for equipment used to manufacture the specified batches was not... Class II Mylan Pharmaceuticals Inc.
Apr 24, 2018 Chlorhexidine 0.12% liquid, 473 MILLITERS. Rx Only. Mnfct for: XTTRUM Laborat... Labeling: Not Elsewhere Classified: due to a labeled declaration of; Store at 15¿C to 30¿C (59¿F... Class II Prescript Pharmaceuticals, Inc.
Apr 23, 2018 Diltiazem CD (Diltiazem Hydrochloride Extended-Release Capsules, USP) 180 mg,... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 240 mg, 100-count bottles, Rx On... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 23, 2018 Metoprolol Succinate Extended-Release Tablets, USP, 100 mg, 100 Tablets bottl... Presence of Foreign Tablets/Capsules: One foreign tablet identified as Clopidogrel 75 mg was foun... Class II Dr. Reddy's Laboratories, Inc.
Apr 23, 2018 Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx on... Failed Dissolution Specifications. High dissolution results were obtained during stability testing. Class III Mckesson Packaging Services
Apr 20, 2018 Diclofenac Sodium and Misoprostol Delayed Release Tablets 75 mg/0.2 mg, 60-co... Labeling: Label Mix-Up: bottle labeled as Diclofenac Sodium and Misoprostol 75 mg/0.2 mg containe... Class II Exela Pharma Sciences LLC

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.