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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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Showing 7,741–7,760 of 17,964 drug recalls

Drug Recall Terminated Historical recordClass II

Isoproterenol HCL in D5W (Non Sterile to Sterile), 200mcg/50mL (4mcg/mL), 50mL Sterile Single-Dose Bag, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-240-57, barcode 0 69623 24057 7.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Recall initiated
June 18, 2019
Reported by FDA
July 3, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Droperidol Injectable Sterile Solution, 0.625mg/mL, 1mL in a 3mL Sterile Single-Use Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-185-10, barcode 0 69623 18510 5.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Recall initiated
June 18, 2019
Reported by FDA
July 3, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ChlorproMAZINE HCL INJ, 25mg/mL, *Contains Sulfites*, 1mL in a 5mL Sterile SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-122-28, barcode 7 69623 12228 4.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Recall initiated
June 18, 2019
Reported by FDA
July 3, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Brilliant Blue Ophthalmic PF INJ, 0.5mg/mL (0.05%), 1 mL SDV, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-211-31, barcode 2 69623 21131 0.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Recall initiated
June 18, 2019
Reported by FDA
July 3, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Atropine Sulfate PF INJ, 0.8 mg/2 mL (0.4 mg/mL), 2mL Single Dose Syringe, Rx only, Premier Pharmacy Labs, 8265 Commercial Way, Weeki Wachee, FL 34613, NDC: 69623-131-12, barcode 0 69623 13112 6.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility: FDA inspection found insufficient environmental controls, potential cross contamination and lack of product specific process validations that can result in a lack of sterility assurance.
Recall initiated
June 18, 2019
Reported by FDA
July 3, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MethylPREDNISolone Tablets, USP 8 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-917-11

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 1.5 mg 90-count bottle, Rx only Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ NDC 68382-200-16

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MethylPREDNISolone Tablets, USP 32 mg, 25 tablets, Rx Only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-919-11

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MethylPREDNISolone Tablets, USP 16 mg, 50 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India NDC 68382-918-18

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MethylPREDNISolone Tablets, USP 4 mg per tablet, 21 Tablets dosepack, Rx Only, Made in India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-916-34

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

MethylPREDNISolone Tablets, USP, 4 mg, 100 tablets, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India NDC 68382-916-01

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 1 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-199-16

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 0.5 mg, 90-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-198-16

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 0.25 mg, 1000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. NDC 68382-197-10

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochoride Tablets 0.25 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-197-16

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pramipexole DihydrochlorideTablets 0.125 mg, 90-count bottle, Rx Only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India. Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-16

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Pramipexole Dihydrochloride Tablets 0.125 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd Ahmedabad, India, Distributed by: Zydus Pharmaceuticals USA Inc. Pennington, NJ 08534. NDC 68382-196-10

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Anastrozole Tablets, USP, 1 mg, 1,000-count bottle, Rx only, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534. NDC 68382-209-10

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

ANASTROZOLE Tablets, 1 mg, Rx Only, 30-count bottle, Manufactured by: Cadila Healthcare Ltd. Ahmedabad, India. Distributed by: Zydus Pharmaceuticals (USA) Inc. Pennington, NJ 08534 NDC 68382-209-06

by Zydus Pharmaceuticals USA Inc

Reason
CGMP Deviations: Cross Contamination with other products due to CGMP cleaning failure.
Recall initiated
May 6, 2019
Reported by FDA
June 26, 2019
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Robafen DM, Generic for Robitussin DM, In each teaspoonful (5mL): Dextromethorphan HBr, USP 10mg,/Guaifenesin, USP 100mg, 118mL (4oz) bottle, Manufactured for Preferred Pharmaceuticals, Inc., Anaheim, CA 92807 by Major Pharmaceuticals, Livonia, MI 48152, NDC 68788-0841-01

by Preferred Pharmaceuticals, Inc

Reason
CGMP Deviations: Potential product contamination with Burkholderia cepacia (B.cepacia) and Ralstonia pickettii (R. pickettii).
Recall initiated
June 10, 2019
Reported by FDA
June 26, 2019
Distribution
Distribution was made to CA and FL.

View recall →

Data last updated:

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.