Browse Drug Recalls

14,380 FDA drug safety recalls.

FDA Drug Recall Enforcement Database

Browse 14,380 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 14,380 FDA drug recalls, Class II.

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DateProductReasonClassFirm
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 7, 2018 Geritrex Senna Syrup (sennosides 8.8mg), packaged in 8 FL OZ. (236 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 Extra Strength (Aluminum Hydroxide 400mg, Mag... CGMP Deviations: Products are being recalled due to an out of specification total aerobic microbi... Class II RIJ Pharmaceutical LLC
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 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 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 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 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...
Apr 30, 2018 PrednisoLONE Sodium Phosphate Orally Disintegrating Tablets 15 mg, Rx Only, ... CGMP Deviations Class II Mylan Pharmaceuticals Inc.
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 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 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 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 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 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
Apr 19, 2018 Sulfamethoxazole and Trimethoprim Tablets USP, 800 mg/160 mg, Rx Only, 500-co... Presence of Foreign Substance:Sun Pharma is recalling one (1) lot of Sulfamethoxazole and Trimeth... Class II Sun Pharmaceutical Industries, Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 13, 2018 Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufac... Subpotent Drug Class II Lyne Laboratories, Inc.
Apr 11, 2018 NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Pre... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syri... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 11, 2018 Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. ... Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of sub... Class II Premier Pharmacy Labs Inc
Apr 10, 2018 Kit for the Preparation of Technetium TC-99M Mebrofenin, 45 mg in 10 mL (5 co... Failed Stability Specifications Class II Pharmalucence, Inc.
Apr 9, 2018 Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.... Defective Delivery System: Out of specification for adhesive transfer. Class II Noven Pharmaceuticals, Inc.
Apr 5, 2018 LIPO-B Injectable-30 mL MDV Coastal Meds LLC 1759 Medical Park Dr., Ste C Bio... Presence of Particulate matter. Recall due to presence of unknown particulate matter. Class II Coastal Meds, 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.