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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

Oxybutynin Chloride Extended-Release Tablets USP 10 mg, a) 100 tablets (NDC 68382-256-01) and b) 500 tablets (NDC 68382-256-05) bottles, Rx Only, Manufactured by: Cadila Healthcare Ltd., Ahmedabad, India, Distributed by: Zydus Pharmaceuticals (USA) Inc., Pennington, NJ 08534

by Zydus Pharmaceuticals (USA) Inc

Reason: Failed Dissolution Specifications
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA.

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Drug Recall Ongoing Historical recordClass I

Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.

by Dr. Berne's Whole Health Products

Reason: Non-Sterility
Recall initiated: August 26, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

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Drug Recall Ongoing Historical recordClass II

Dr. Berne's MSM DROPS 5% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001111.

by Dr. Berne's Whole Health Products

Reason: CGMP Deviations
Recall initiated: August 26, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

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Drug Recall Ongoing Historical recordClass II

Dr. Berne's Organic Castor Oil Eye Drops, Net WT 30 mL/1 fl oz bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, Certified Organic by Organic Certifiers.

by Dr. Berne's Whole Health Products

Reason: CGMP Deviations
Recall initiated: August 26, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

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Drug Recall Ongoing Historical recordClass II

Dr. Berne's MSM MIST 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com.

by Dr. Berne's Whole Health Products

Reason: CGMP Deviations
Recall initiated: August 26, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

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Drug Recall Ongoing Historical recordClass II

Dr. Berne's MSM DROPS 15% Solution, 30 mL/1.014 OZ bottle, Distributed by: Dr. Berne's Whole Health Products, Tesuque, NM, 87574, hello@drsamberne.com, UPC 00854582001036

by Dr. Berne's Whole Health Products

Reason: CGMP Deviations
Recall initiated: August 26, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide and UK, Canada, Italy, India, Australia, Germany, Switzerland, Singapore, Netherlands, Ireland, South Korea, Belgium, Norway, Saudi- Arabia, Slovenia, Malta, Israel, Sweden, Latvia, Portugal, Hong Kong, Kuwait, Romania, South Africa, Thailand, Zambia, France, Finland, Mauritius, Barbados.

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Drug Recall Terminated Historical recordClass II

HYDROmorphone in dextrose 5%, 0.5 mg/5 mL, (0.1 mg/mL), 5 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% Sodium Chloride, 30 mg/30 mL, (1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2012-1

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

HYDROmorphone in dextrose 5%, 3 mg/30 mL, (0.1 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2013-2

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% sodium chloride, 15 mg/30 mL, (0.5 mg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2011-1

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% sodium chloride, 10 mg/50 mL, (0.2 mg/mL), 50 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-2010-2

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

HYDROmorphone in 0.9% sodium chloride, 6 mg/30 mL, (0.2 mg/mL), 30 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2010-1

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

succinylcholine, 200 mg/10 mL, (20 mg/mL), 10 mL syringe, Rx only, CAPS, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC 71286-6011-2

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL, 1,250 mcg/25 mL, (50 mcg/mL), 30 mL Syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-7

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL in dextrose 5%, 300 mcg/30 mL, (10 mcg/mL), 30 mL syringe, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2001-2

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL, 5,000 mcg/100 mL, (50 mcg/mL), 100 mL Bag, Rx only, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-5

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 100 mL bag, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-4

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL, 2500 mcg/50 mL, (50 mcg/mL), 50 mL Syringe, Rx only, CAPS, Central Admixture Pharmacy Services, Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-3

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL, 250 mcg/5 mL, (50 mcg/mL), 5 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-2

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

fentaNYL, 100 mcg/2 mL, (50 mcg/mL), 3 mL Syringe, Rx only, Repackaged by CAPS Inc., 7935 Dunbrook Road, Suite C, San Diego, CA 92126, NDC: 71286-2003-1

by Central Admixture Pharmacy Services Inc

Reason: Lack of assurance of sterility:
Recall initiated: September 21, 2023
Reported by FDA: October 11, 2023
Distribution: Nationwide in the USA

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Data last updated: November 1, 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.