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FDA Drug Recalls

Every FDA drug enforcement recall Public Health Trace has on record, republished from openFDA's official drug enforcement database. See Health Alerts for current, active recalls alongside outbreaks and advisories.

Drug recall information is sourced from the FDA's structured openFDA Enforcement Reports. Newly announced recalls may appear on FDA.gov before they become available in the structured dataset. See Methodology for how Public Health Trace imports and refreshes this data.

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Drug Recall Terminated Historical recordClass II

Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11

by Upsher Smith Laboratories, Inc.

Reason: Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Recall initiated: September 19, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide USA, Puerto Rico and Guam

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Drug Recall Terminated Historical recordClass II

Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11

by Upsher Smith Laboratories, Inc.

Reason: Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
Recall initiated: September 19, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide USA, Puerto Rico and Guam

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Drug Recall Terminated Historical recordClass III

Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684

by Promise Pharmacy LLC

Reason: Presence of precipitate
Recall initiated: October 18, 2018
Reported by FDA: October 31, 2018
Distribution: U.S.A. Nationwide.

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Drug Recall Terminated Historical recordClass II

Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450

by RXQ Compounding LLC

Reason: Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
Recall initiated: September 25, 2018
Reported by FDA: October 31, 2018
Distribution: U.S.A. nationwide

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Drug Recall Terminated Historical recordClass II

Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01

by Teva Pharmaceuticals USA

Reason: Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
Recall initiated: October 19, 2018
Reported by FDA: October 31, 2018
Distribution: U.S.A. Nationwide including Puerto Rico.

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Drug Recall Terminated Historical recordClass II

PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: August 6, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: August 6, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: August 6, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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Drug Recall Terminated Historical recordClass II

Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: August 6, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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Drug Recall Terminated Historical recordClass II

Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: August 6, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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Drug Recall Terminated Historical recordClass II

Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: August 6, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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Drug Recall Terminated Historical recordClass II

Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054

by Teva Pharmaceuticals USA

Reason: Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
Recall initiated: August 6, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed throughout the United States. Bulk product was distributed to Takeda, Deerfield, IL and may have been further distributed.

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Drug Recall Terminated Historical recordClass II

Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11

by Pfizer Inc.

Reason: Lack of assurance of sterility: loss of container integrity.
Recall initiated: September 20, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide in the US and Puerto Rico

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Drug Recall Terminated Historical recordClass II

Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31

by Heritage Pharmaceuticals, Inc.

Reason: Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
Recall initiated: October 15, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Amlodipine/Valsartan HCTZ 10 mg/320 mg/25 mg tablets, HDPE 90 cc bottles in cardboard trays Original NDC 13668-0325-30 Repackaged NDC 70518-1220-00

by RemedyRePack Inc.

Reason: CGMP Deviations: Detection of trace amounts of NDMA, a possible impurity or contaminant in an active pharmaceutical ingredient.
Recall initiated: August 24, 2018
Reported by FDA: October 31, 2018
Distribution: Product was distributed to a medical facility in South Carolina

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Drug Recall Terminated Historical recordClass II

Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60

by LUPIN SOMERSET

Reason: Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
Recall initiated: October 5, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Cyclosporine 1% Human Eye Drops, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-2776-92

by Westlab Pharmacy, Inc. dba Westlab Pharmacy

Reason: Lack of Process Controls
Recall initiated: August 10, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

ADAA Cataract Drops, (Lido 1.47%, Phenyleph 0.294% Cyclopentolate 0.147%, Tropicamide 0.0735%, Moxiflox 0.0294%, Ketorolac 0.0147%) 1x 1cc syringe, Westlab Pharmacy, Inc., Gainesville, FL 32607 --- NDC 10002-2579-05

by Westlab Pharmacy, Inc. dba Westlab Pharmacy

Reason: Lack of Process Controls
Recall initiated: August 10, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass II

Alprostadil 500 mcg/mL Injectable, Vials, Westlab Pharmacy, Inc., Gainesville, FL 32607 NDC 10002-7335-00

by Westlab Pharmacy, Inc. dba Westlab Pharmacy

Reason: Incorrect Product Formulation
Recall initiated: August 10, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide

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Drug Recall Terminated Historical recordClass III

Testosterone Topical Solution, 30mg/1.5mL, 110mL bottles, Rx only, Manufactured for: Lupin Pharmaceuticals Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775 INDIA, NDC 68180-943-11

by Lupin Pharmaceuticals Inc.

Reason: Defective Container: Repetitive complaints received indicating pump not working.
Recall initiated: October 9, 2018
Reported by FDA: October 31, 2018
Distribution: Nationwide within the United States

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Data last updated: September 22, 2026 ET

This information is republished from FDA's Recall Enterprise System through openFDA. Public Health Trace does not verify or supplement it, is not affiliated with the FDA, and does not provide medical advice -- always follow the guidance of your pharmacist, physician, or the recalling company for any medication you take. Read the full medical disclaimer.