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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 III

Fentanyl Buccal Tablets CII, 400mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-636-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Recall initiated: April 27, 2023
Reported by FDA: May 31, 2023
Distribution: US Nationwide

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Drug Recall Terminated Historical recordClass III

Fentanyl Buccal Tablets CII, 200mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-635-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Recall initiated: April 27, 2023
Reported by FDA: May 31, 2023
Distribution: US Nationwide

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Drug Recall Terminated Historical recordClass III

Fentanyl Buccal Tablets CII, 100mcg, packaged in cartons of 28 Buccal Tablets (4 tablets x 7 cards), Rx only, Distributed by: Mayne Pharma, Greenville, NC 27834, NDC 51862-634-28

by Teva Pharmaceuticals USA Inc

Reason: Labeling: Incorrect or Missing Package Insert
Recall initiated: April 27, 2023
Reported by FDA: May 31, 2023
Distribution: US Nationwide

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Drug Recall Completed Historical recordClass II

Pain Reliever, Acetaminophen USP Caplets, 500 mg, 225-count bottles packaged in a cardboard carton, Distributed by: Walgreen Co., 200 Wilmot Rd, Deerfield, IL 60015; NDC 0363-9947-35.

by Aurobindo Pharma USA Inc.

Reason: Failed Impurities/Degradation Specifications: firm's investigation due to customer complaints for discoloration found that the product was out of specification for an impurity.
Recall initiated: May 22, 2023
Reported by FDA: May 31, 2023
Distribution: The recalled product was distributed to one Retail Distributor (Walgreens) who further distributed Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass II

Nafcillin for Injection, USP, 10 gram per Pharmacy Bulk Package, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-141-99

by Sagent Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility
Recall initiated: May 19, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Nafcillin for Injection, USP, 2 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-140-10

by Sagent Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility
Recall initiated: May 19, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide USA

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Drug Recall Ongoing Historical recordClass II

Nafcillin for Injection, USP, 1 gram per vial, Rx only, Mfd. for SAGENT Pharmaceuticals, Schaumburg, IL 60195. NDC: 25021-139-10

by Sagent Pharmaceuticals Inc

Reason: Lack of Assurance of Sterility
Recall initiated: May 19, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

buPROPrion Hydrochloride Extended-Release Tablets, USP (SR) 150 mg, 60 Tablets, Rx Only, Distributed by: Sun Pharmaceutical Industries, Inc., Cranbury, NJ, Manufactured by: Sun Pharmaceutical Industries Limited, Gujrat, India, NDC 47335-737-86

by SUN PHARMACEUTICAL INDUSTRIES INC

Reason: Failed Dissolution Specifications; during stability testing
Recall initiated: May 9, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the U.S.A

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Drug Recall Terminated Historical recordClass II

FOAMING HAND SANITIZER, fresh mint scent, 62% alcohol, 1 Gallon / 3.78 Liters bottle, 290 Alpha Drive RIDC industrial Park, Pittsburgh, PA 15238,

by Alpha Aromatics

Reason: CGMP Deviations: FDA analysis found product to contain acetaldehyde and acetal above specification limits.
Recall initiated: May 16, 2023
Reported by FDA: May 31, 2023
Distribution: Product was distributed to one account in NC.

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Drug Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 4 mg, RX, Packaged as a) 100-count bottle, NDC# 68001-179-00; b) 500-count bottle, NDC# 68001-179-03, Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated: March 17, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 2 mg, RX, Packaged as a ) 100-count bottle, NDC# 68001-178-00; b) 500-count bottle; NDC# 68001-178-03 Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213, INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated: March 17, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass II

Glimepiride Tablets, USP, 1 mg, RX, Packaged as a)100-count bottle, NDC# 68001-177-00; b) 500-count bottle, NDC# 68001-177-03; Manufactured by: Intas Pharmaceuticals Limited, Pharmez, Ahmedabad-382 213. INDIA. For BluePoint Laboratories

by Amerisource Health Services LLC

Reason: CGMP Deviations: recalling drug products following an FDA inspection.
Recall initiated: March 17, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide USA

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Drug Recall Terminated Historical recordClass III

Methylprednisolone Acetate Injectable Suspension, USP 80 mg/mL, For Intramuscular, Intrasynovial and Soft Tissue Injection Only, Not for Intravenous Use, 1 mL Single Dose Vial, Manufactured by: Amneal Pharmaceuticals Pvt. Ltd. Parenteral Unit, Ahmedabad 382213, India, Amneal Pharamceuticals LLC, Bridgewater, NJ 08807, NDC 70121-1574-01.

by Amneal Pharmaceuticals of New York, LLC

Reason: Labeling: Not Elsewhere Classified; A typographical error was observed in the NDC number on the preprinted Individual Folding Cartons (secondary packaging only). Incorrect NDC Number 70121-1573-1; Correct NDC Number 70121-1574-1.
Recall initiated: May 8, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA and PR

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Drug Recall Terminated Historical recordClass II

HyperLyte CR Injection, 250 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-2, code 7128580942.

by Central Admixture Pharmacy Services, Inc.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: April 28, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

HyperLyte CR Injection, 500 mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8094-1, code 7128580941.

by Central Admixture Pharmacy Services, Inc.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: April 28, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Lidocaine 2% HCl Inj, 500mL bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8091-1, code 7128580911.

by Central Admixture Pharmacy Services, Inc.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: April 28, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Potassium Acetate Injection, 2 mEq/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8078-1, code 7128580781.

by Central Admixture Pharmacy Services, Inc.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: April 28, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

Sodium Phosphates Injection 4 mEq/3 mMol/mL, 500 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8077-1, code 7128580771.

by Central Admixture Pharmacy Services, Inc.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: April 28, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

MSA 7.84% MSG 8.56% (0.92M) Comp. Sol. 1000 ml bag, Rx only, Central Admixture Pharmacy Services, 6580 Snowdrift Road, Allentown, PA 18106, NDC 71285-8029-1, code 7128580291.

by Central Admixture Pharmacy Services, Inc.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: April 28, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA.

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Drug Recall Terminated Historical recordClass II

vasopressin 50 units added to 0.9% sodium chloride 50 mL, 1 unit/mL, 50 mL in 100 mL Partial Additive Bag, Rx only, Central Admixture Pharmacy Services, Inc., 6580 Snowdrift Rd., Ste 100, Allentown, PA 18106, NDC 71285-9002-1.

by Central Admixture Pharmacy Services, Inc.

Reason: Lack of Assurance of Sterility: after an FDA inspection called into question the sterility of the products intended to be sterile.
Recall initiated: April 28, 2023
Reported by FDA: May 31, 2023
Distribution: Nationwide in the USA.

View recall →

Data last updated: September 11, 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.