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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 321–340 of 17,898 drug recalls

Drug Recall Ongoing 2026 recordClass II

Isotretinoin Capsules, USP, 40 mg, 10 count Prescription Pacs, Rx only, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2436-15 (carton), NDC 0591-2436-45 (blister pack).

by Teva Pharmaceuticals USA, Inc

Reason
Superpotent and Subpotent
Recall initiated
January 12, 2026
Reported by FDA
April 15, 2026
Distribution
FL, OH, PR & MS

View recall →

Drug Recall Ongoing 2026 recordClass II

Isotretinoin Capsules, USP, 30 mg, Rx Only, 10 count Prescription Pack, Manufactured for: Teva Pharmaceuticals USA, Inc., Parsippany, NJ 07054, NDC 0591-2435-15 (carton), NDC 0591-2435-45 (blister pack).

by Teva Pharmaceuticals USA, Inc

Reason
Superpotent and Subpotent
Recall initiated
January 12, 2026
Reported by FDA
April 15, 2026
Distribution
FL, OH, PR & MS

View recall →

Drug Recall Ongoing 2026 recordClass II

Xanax XR, alprazolam, extended-release tablets, 3 mg, 60 Tablets bottles, Rx only, Distributed by: Viatris Specialty LLC, Morgantown, WV 06506, U.S.A, Made in Ireland, NDC 58151-506-91

by Viatris, Inc.

Reason
Failed Dissolution Specifications
Recall initiated
March 17, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide.

View recall →

Drug Recall Ongoing 2026 recordClass II

Artificial Tears Lubricant Eye Drops (glycerin 0.2%, hypromellose 0.2%, polyethylene glycol 400 1%), 0.5 oz bottles, Mfg: Geri-Care; Brooklyn, New York NDC 68788-7266-0

by Preferred Pharmaceuticals, Inc.

Reason
Lack of Assurance of Sterility
Recall initiated
March 25, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide within the United States

View recall →

Drug Recall Ongoing 2026 recordClass II

Vancomycin HCL, 1 gram added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5082-01

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

Vancomycin HCI, 1.5 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5085-01

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

Vancomycin HCI, 1.25 grams added to 250 mL, 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5083-01

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

norepinephrine Bitartrate, 32mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5027-02

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

norepinephrine Bitartrate,16mg per 250mL 0.9% Sodium Chloride Injection USP, Fagron Sterile Services, 8710 34th St. N. Wichita, KS 67226, NDC 71266-5026-02

by Fagron Compounding Services

Reason
Lack of Assurance of Sterility; blue Break-Off-Part could detach from the administration port
Recall initiated
March 20, 2026
Reported by FDA
April 15, 2026
Distribution
Nationwide in the U.S.A.

View recall →

Drug Recall Ongoing 2026 recordClass II

5% Dextrose Injection, USP 12.5 g per 250 mL (50 mg per mL) 250 mL in a 250 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-458-05, Unit of Sale NDC Number: 65219-458-30.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

5% Dextrose Injection, USP 5 g per 100 mL (50 mg per mL) 100 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-464-05, Unit of Sale NDC Number: 65219-464-50.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

5% Dextrose Injection, USP 2.5 g per 50 mL (50 mg per mL) 50 mL in a 100 mL freeflex bag, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Use NDC: 65219-456-05, Unit of Sale NDC Number: 65219-456-60.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL), 1,000 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Becton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by Fresenius Kabi, Unit of Sale NDC Number: 17271-701-07.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 1,000 mL in a Single Dose freeflex bag, 1,000 mLx10, Fresenius Medical Care, Waltham, MA 02451, Distributed by: Fresenius Medical Care RTG, LLC, Manufactured by: Fresenius Kabi, Unit of Use NDC: 65219-282-01, Unit of Sale NDC Number: 65219-282-10.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP 900 mg per 100 mL (9 mg per mL) 500 mL in a Single Dose freeflex bag, 500 mL x 20, Manufactured for: Fresenius Kabi USA, LLC ("Fresenius Kabi"), IL 60047, Unit of Use NDC: 65219-432-20, Unit of Sale NDC Number: 65219-432-85.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 250 mL in a Single Dose freeflex bag, Rx only, BD Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-05.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP, 900 mg per 100 mL (9 mg per mL) 100 mL in a Single Dose freeflex bag, Rx only, BD Beckton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by: Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-03.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP, 50 mL x60, Becton, Dickson and Company, 1 Beckton Drive, Franklin Lakes, NJ 07417 USA, Distributed by BD, Manufactured by Fresenius Kabi USA, LLC ("Fresenius Kabi"), Unit of Sale NDC Number: 17271-701-02.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP, (4,500 mg per 500 mL) (9 mg per mL) 500 mL in a 500 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-472-05, Unit of Sale NDC Number: 65219-472-20.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

View recall →

Drug Recall Ongoing 2026 recordClass II

0.9% Sodium Chloride Injection, USP, (2,250 mg per 250 mL) (9 mg per mL) 250 mL in a 250 mL freeflex bag, Rx only, Fresenius Kabi USA, LLC ("Fresenius Kabi"), Lake Zurich, IL 60047, Unit of Use NDC: 65219-470-05, Unit of Sale NDC Number: 65219-470-30.

by Fresenius Kabi USA, LLC

Reason
Lack of Assurance of Sterility
Recall initiated
March 11, 2026
Reported by FDA
April 15, 2026
Distribution
US Nationwide , Alaska, and Puerto Rico.

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.