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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 9,681–9,700 of 17,974 drug recalls

Drug Recall Terminated Historical recordClass III

Diltiazem HCl Extended-Release Capsules, USP 120 mg, 100-count bottles, Rx only, Mfg. By: Par Pharmaceutical One Ram Ridge Rd Chestnut Ridge, NY 10977. NDC: 63739-014-10

by Mckesson Packaging Services

Reason
Failed Dissolution Specifications. High dissolution results were obtained during stability testing.
Recall initiated
April 23, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide with the US

View recall →

Drug Recall Terminated Historical recordClass II

Fluocinolone Acetonide Topical Oil, 0.01% (Scalp Oil) 118.28 mL (4 fl.oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-330-04, UPC 364980330046

by Lyne Laboratories, Inc.

Reason
Subpotent Drug
Recall initiated
April 13, 2018
Reported by FDA
May 2, 2018
Distribution
to be entered

View recall →

Drug Recall Terminated Historical recordClass II

Fluocinolone Acetonide Topical Oil, 0.01% (Ear Drops) 20 mL, Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-329-20, UPC 364980329200

by Lyne Laboratories, Inc.

Reason
Subpotent Drug
Recall initiated
April 13, 2018
Reported by FDA
May 2, 2018
Distribution
to be entered

View recall →

Drug Recall Terminated Historical recordClass II

Fluocinolone Acetonide Topical Oil, 0.01% (Body Oil) 118.28 mL (4 fl. oz.) Rx Only, Manufactured by: Lyne Laboratories, Inc. Brockton, MA 02307 Manufactured for: Rising Pharmaceuticals, Inc. Allendale, NJ 07401, NDC 64980-331-04, UPC 364980331043

by Lyne Laboratories, Inc.

Reason
Subpotent Drug
Recall initiated
April 13, 2018
Reported by FDA
May 2, 2018
Distribution
to be entered

View recall →

Drug Recall Terminated Historical recordClass II

NEOstigmine Methylsulfate (1 mg/mL) 3mg per 3mL. 3mL Single Dose Syringe. Premier Pharmacy Labs. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-234-14.

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Recall initiated
April 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Hydromorphone HCl 1 mg/mL PF INJ. 1mL in a 3mL Sterile Single-Dose Syringe. 8265 Commercial Way Weeki Wachee, FL 34613 NDC 69623-249-10

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Recall initiated
April 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 4 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-127-10

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Recall initiated
April 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Morphine Sulfate 2 mg/mL PF Injection. 1 mL in a 3ml Sterile Single-Dose Syringe. 8265 Commerical Way Weeki Wachee, FL 34613. NDC 69623-129-10

by Premier Pharmacy Labs Inc

Reason
Lack of Assurance of Sterility:Microbial contamination was detected during routine testing of subsequent unreleased product lots due to interaction between the product syringe and tamper evident container closure, which may result in the potential introduction of microorganisms into the products.
Recall initiated
April 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass I

All Alka-Seltzer Plus¿ packages with a full front panel instant Redeemable Coupon (IRC) affixed to the individual carton. The recalled products can be identified by checking the Bayer logo located on the lower left corner of the front of the carton. If the logo has an orange or green background, the product is included in the recall.

by Bayer HealthCare Pharmaceuticals, Inc.

Reason
Labeling: Label Mix-Up: Bayer is recalling all Alka-Seltzer Plus packages, with a green or orange Bayer logo located on the lower left corner of the front of the carton, because the ingredients on the front sticker may not match the actual product in the carton.
Recall initiated
March 15, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide in the USA

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 53943-292-15), b) 100 caplets (NDC 53493-292-12), and c) 500 caplets (NDC 53493-292-14) bottles, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Caplets USP 200 mg, a) 50 caplets (NDC 49483-600-05), b) 100 caplets (NDC 49483-600-01), c) 500 caplets (NDC 49483-600-50), and d) BULK (NDC 49483-600-00) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 42582-113-10) and b) 500 tablet (NDC 42582-113-18) bottles, Rx, Distributed by; Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP 800 mg, a) 100 tablet (NDC 49483-604-01) and b) 500 tablet (NDC 49483-604-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 42582-112-01), b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP 600 mg, a) 100 tablets (NDC 42582-112-10) and b) 500 tablet bottles (NDC 42582-112-18), Rx, Distributed by: Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP 600 mg, a) 100 tablet (NDC 49483-603-01) and b) 500 tablet bottles (NDC 49483-603-50), Rx, Manufactured for: Time Caps Labs, Farmingdale, NY, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP 400 mg, 500 tablet bottles (NDC 42582-111-18), Rx, Distributed by Bi-Coastal Pharma International, Shrewsbury, NJ, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets USP 400 mg, a) 100 tablet (NDC 49483-602-01) and b) 500 tablet (NDC 49483-602-50) bottles, Rx, Manufactured for: Time Cap labs, Inc., Farmingdale, NY 11735, USA, Manufactured by: Marksans Pharma, Ltd., Plot No. L-82, L-83 Verna indl. Estate Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP, 200 mg, a) 50 tablet (NDC 53943-291-15), b) 100 tablet (NDC 53943-291-12), c) 500 tablet (NDC 53943-291-14), Brown, Distributed by Drug Mart, Food Fair, Medina, Ohio 44256

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

View recall →

Drug Recall Terminated Historical recordClass II

Ibuprofen Tablets, USP, 200 mg, a) 50 tablets (NDC 49483-601-05), b) 100 tablets (NDC- 49483-601-01), c) 500 tablets (NDC 49483-601-50), d) 1000 tablets (NDC 49489-601-10), e) Bulk (49483-601-00) bottles, Brown, Manufactured for: Time Cap Labs, Inc., Farmingdale, NY 11735, Manufactured by: Marksans Pharma, Ltd., Verna, Goa-403 722, India

by Time-Cap Laboratories, Inc.

Reason
CGMP Deviations: Various strengths of ibuprofen tablets/caplets are being recalled due to complaints of odor related to CGMP deficiencies.
Recall initiated
January 11, 2018
Reported by FDA
May 2, 2018
Distribution
Nationwide.

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.