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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 6,101–6,120 of 17,964 drug recalls

Drug Recall Ongoing Historical recordClass II

LidoPro (lidocaine 4%, menthol 5%, methyl salicylate 4%) patch, 15 Patches per box, Manufactured For: Terrain Pharmaceuticals, Reno, NV 89501; NDC 53225-1023-1.

by Wuhan Bingbing Pharmaceutical Co., Ltd.

Reason
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Recall initiated
May 19, 2020
Reported by FDA
June 3, 2020
Distribution
Nationwide in the USA

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Drug Recall Ongoing Historical recordClass II

LidoPatch (lidocaine HCl 3.6%, menthol 1.25%) Pain Relief Patch, packaged in 1 patch/box (NDC 10882-527-01); 30 patches/box (NDC 10882-527-02 and 10882-527-04), Manufactured for: JAR Laboratories, Elmhurst, IL.

by Wuhan Bingbing Pharmaceutical Co., Ltd.

Reason
CGMP Deviations: due to the loss of product manufacturing records and retain product samples, there is no assurance that the product will remain within specification through the labeled expiration date.
Recall initiated
May 19, 2020
Reported by FDA
June 3, 2020
Distribution
Nationwide in the USA

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Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate tablets USP, 100 mg, packaged in bottles a) 6-count (NDC 55289-866-06), b) 10-count (NDC 55289-866-10), c) 14-count (NDC 55289-866-14), d) 20-count (NDC 55289-866-20), e) 28-count (NDC 55289-866-28), f) 30-count (NDC 55289-866-30), g) 60-count (NDC 55289-866-60), h) 120-count (NDC 55289-866-98), i) 210-count (NDC 55289-866-71), j) 300-count (NDC 55289-866-87), k) 400-count (NDC 55289-866-74), Rx only, PD-Rx Pharmaceuticals Incorporated Oklahoma City, OK 73127

by PD-Rx Pharmaceuticals, Inc.

Reason
Failed dissolution specifications
Recall initiated
May 15, 2020
Reported by FDA
June 3, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass II

Doxycycline Hyclate Tablets USP, 100 mg, packaged in a) 50-count bottle (NDC 0143-2112-50), b) 500-count bottle (NDC 0143-2112-05), Rx only, Mfd. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724.

by West-Ward Columbus Inc

Reason
Failed dissolution specification: The dissolution test at the 24 month time point (end of shelf life) yielded an out of specification result.
Recall initiated
May 13, 2020
Reported by FDA
June 3, 2020
Distribution
USA Nationwide

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Drug Recall Terminated Historical recordClass III

Ethacrynic Acid Tablets USP, 25 mg, 100 Tablets per Bottle, Rx only, Distr. by: West-Ward Pharmaceuticals Corp., Eatontown, NJ 07724, NDC: 0054-0415-25.

by West-Ward Columbus Inc

Reason
Failed Impurities/Degradation Specifications: Out of Specification for impurity 6 and total degradants.
Recall initiated
May 13, 2020
Reported by FDA
May 27, 2020
Distribution
Nationwide in the US

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Drug Recall Terminated Historical recordClass III

Gabapentin Tablets USP, 600 mg, Rx Only, 500-count bottle, Manufactured for: Exelan Pharmaceuticals, Inc., Lawrenceville, GA 30046, Manufactured by: InvaGen Pharmaceuticals, Inc., Hauppauge, NY 11788, NDC 76282-405-05.

by InvaGen Pharmaceuticals, Inc.

Reason
Failed Impurities/Degradation Specifications; failure of Impurity A test at the 12-month long-term stability testing.
Recall initiated
May 14, 2020
Reported by FDA
May 27, 2020
Distribution
Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass II

Aloprim (allopurinol sodium) for Injection, 500 mg Single-Dose Vial, Rx only, Manufactured for: Mylan Institutional LLC, Rockford, IL 61103 USA. NDC: 67457-187-50

by Mylan Institutional LLC

Reason
Discoloration: Out-of-specification results for appearance obtained during routine stability testing at the end of shelf-life for the parameters Appearance and Color of Solution.
Recall initiated
May 5, 2020
Reported by FDA
May 27, 2020
Distribution
Distributed Nationwide in the USA

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Drug Recall Terminated Historical recordClass I

LACTATED RINGER'S Injection, USP 1000 mL flexible container, Rx Only, Hospira, Inc., Lake Forest, IL 60045, NDC 0409-7953-09

by ICU Medical Inc

Reason
Presence of Particulate Matter: confirmed customer complaint for the presence of particulate matter identified as iron oxide.
Recall initiated
May 8, 2020
Reported by FDA
May 27, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

Finasteride Plus 1.25 mg Capsule, a) 30-count bottle, b) 90-count bottle, Compounded Product Not for Resale, MasterPharm, 115-02 Liberty Ave, Richmond Hill, NY 11419.

by MasterPharm LLC

Reason
Cross Contamination with Other Products; Finasteride Plus 1.25mg capsules were found to contain minoxidil.
Recall initiated
April 14, 2020
Reported by FDA
May 20, 2020
Distribution
Nationwide in the U.S.

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Drug Recall Terminated Historical recordClass III

ChapStick Total Hydration Moisture + Tint + SPF15 Pretty in Pink Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0873-08

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Recall initiated
April 20, 2020
Reported by FDA
May 20, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

ChapStick Total Hydration Moisture + Tint + SPF15 Very Berry Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA NDC 0573-0872-08

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Recall initiated
April 20, 2020
Reported by FDA
May 20, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

ChapStick Total Hydration Moisture + Tint + SPF15 Peachy Keen Net Wt. 0.08 OZ (2.2g) Marketed by: Pfizer, Madison, NJ 07940 USA, NDC 0573-0871-08

by Glaxosmithkline Consumer Healthcare Holdings

Reason
Labeling: Not elsewhere classified: Observed separation in the secondary packaging in the blister and the backer card
Recall initiated
April 20, 2020
Reported by FDA
May 20, 2020
Distribution
Nationwide

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Drug Recall Terminated Historical recordClass III

Memantine Hydrochloride Extended-Release Capsules, 28 mg, 100 capsules per unit dose cartons, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, India; Distributed by: Major Pharmaceuticals, 17177 N Laurel Park Dr., Suite 233, Livonia, MI 47152 USA. NDC: 0904-6735-61

by The Harvard Drug Group

Reason
Failed dissolution specifications: Low stage 3 results obtained for dissolution during routine stability testing.
Recall initiated
April 24, 2020
Reported by FDA
May 20, 2020
Distribution
AL, FL, IA, NY, OH, TX

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Drug Recall Terminated Historical recordClass II

Epinephrine Injection USP, 0.3 mg (Auto-Injector), 0.3 mg/ 0.3 mL pre-filled syringe, Rx Only, Manufactured for Teva Pharmaceuticals USA, Inc. North Wales, PA 19454. NDC 0093-5986-27

by Teva Pharmaceuticals USA

Reason
CGMP Deviations: Precautions taken due to Out-of-specification for trigger force for a non-marketed lot number that shares the same component.
Recall initiated
March 5, 2020
Reported by FDA
May 13, 2020
Distribution
Product was distributed to 1 wholesaler who still had all units within their possession and had not shipped or further distributed any of the product.

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Drug Recall Terminated Historical recordClass II

Infuvite PEDiatric Pharmacy, kit in 1 carton (40 mL fill in a 50 mL) vial 1 and (10 mL) in vial 2, Rx Only, Distributed by: Baxter Healthcare Corporation Clintec Nutrition Division Deerfield, IL 60015 USA, NDC 54643-5647-0

by Sandoz, Inc

Reason
Defective Container: Sub-optimal crimping in vial of Pediatric Infuvite Multiple Vitamins
Recall initiated
April 21, 2020
Reported by FDA
May 13, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass I

Ceftazidime for Injection USP and Dextrose for Injection USP, 2 g, 50 mL Duplex Container, RX only, B Braun Medical Inc., Bethlehem, PA 18018-3524, NDC 0264-3145-11

by B. Braun Medical Inc

Reason
Failed Stability Specifications: Out-of-Specification (OOS) results for High Molecular Weight Polymers.
Recall initiated
April 18, 2020
Reported by FDA
May 6, 2020
Distribution
Product was distributed nationwide within the United States.

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Drug Recall Terminated Historical recordClass III

Esomeprazole Magnesium Delayed Release Capsules USP, 40 mg*, 1000-count bottles, Rx only, Mfd. By: Dr. Reddy's Laboratories Limited Bachupally - 500 090 INDIA, NDC 43598-510-10

by Dr. Reddy's Laboratories, Inc.

Reason
Discoloration: product contains brown pellets
Recall initiated
April 24, 2020
Reported by FDA
May 6, 2020
Distribution
Nationwide within the United States

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Drug Recall Terminated Historical recordClass II

Nizatidine Oral Solution, 15 mg/mL (75 mg/5mL) USP 480 mL bottles, Rx Only Distributed by: Gemini Laboratories, LLC Bridgewater, NJ 08807 NDC 60846-301-15

by Amneal Pharmaceuticals of New York, LLC

Reason
CGMP Deviations: potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA.
Recall initiated
April 15, 2020
Reported by FDA
May 6, 2020
Distribution
Nationwide

View recall →

Drug Recall Terminated Historical recordClass II

Cefixime for Oral Suspension USP, 100mg/5mL, Rx Only, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, Maryland 21202 United States, Manufactured by: Lupin Limited Mandideep 462 046 INDIA, NDC 68180-405-01

by Lupin Pharmaceuticals Inc.

Reason
Subpotent Drug: low out of specification (OOS) test result observed in long term stability study.
Recall initiated
April 15, 2020
Reported by FDA
April 29, 2020
Distribution
Nationwide with the United States and Puerto Rico.

View recall →

Drug Recall Terminated Historical recordClass II

PEPPERMINT LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube, labeled as a) Bimark Inc., bimark.com; b) NOCO TRAIL REPORT, www.NoCoTrailReport.org; c) Herbruck's, d) St. Mark's Outpatient Surgery Center, 1250 East 3900 South Suite 100, Salt Lake City, UT 84124, e) Trust Company Oklahoma, trustok.com, f) Creekside Dental, www.creeksidedentalkennewick.com, g) Children's Healthcare of Atlanta Hughes Spalding, h) Great Smiles Orthodontics, Dr. Savage & Dr. Weissman, Crestline. Inverness.Turssville, www.bracebygreatsmiles.com, i) Acceleration station, j) The Children's Therapy & Learning Center, www.childrenstlc.com. FLAVORED LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as a) Gregory P. Miller DDS FAGD, 1140 South Avenue North Mankato, MN 56003, www.gregmillerdds.com, b) Shelby, c) Carolina Custom Traders, Wake Forest, North Carolina, c) Palm Springs Dental Associates Jonathan W. Preble, DMD, 499 E. Central Parkway, Suite 200, Altamonte Springs, FL 32701, www.drjpreble.com. LIP MOISTURIZER (oxybenzone (4%) and Octinoxate (7%) SPF 15, 4.2 g tube labeled as Family Dental of Thronton, 12889 Quebec St, Thornton, CO 80602, www.FamilyDentalofThornton.com.

by Yusef Manufacturing Laboratories, LLC

Reason
Superpotent drug: This lot of SPF containing lip balm contains up to 150% of the label claim for active ingredient Oxybenzone.
Recall initiated
March 3, 2020
Reported by FDA
April 29, 2020
Distribution
Nationwide within the United States

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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.