FDA Recall
TerminatedTerminated: February 6, 2024Historical 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.
- Published
- April 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 7, 2021Historical recordClass II
Lisinopril Tablets USP, 20 mg, 1000-count bottle, Rx Only, Manufactured for: Lupin Pharmaceuticals, Inc. Baltimore MD 21202, Manufactured by: Lupin Limited Pithampur (M.P.) 454 775, India. NDC 68180-0981-03
by Lupin Pharmaceuticals Inc.
- Reason
- Product Mix-Up: a complaint received indicating mix-up of 10 mg Lisinopril tablets inside of 2 sealed bottles of 20 mg/1000 count bottles.
- Published
- April 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 30 mg over 9 hours (3.3 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5555-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 20 mg over 9 hours (2.2 mg/hr) 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5554-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 17, 2024Historical recordClass II
Daytrana (methylphenidate transdermal system) Delivers 10 mg over 9 hours (1.1 mg/hr), 30-count box, Rx only, Manufactured for Noven Therapeutics, LLC Miami, FL 33186, NDC 68968-5552-3
by Noven Therapeutics, LLC
- Reason
- Defective Delivery System: Out of specification for mechanical peel and shear.
- Published
- April 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 24, 2020Historical recordClass II
Estradiol, USP (Non-Micronized) (Hemihydrate), packaged in: a) 500 grams (NDC 63275-9900-8), b) 100 grams (NDC 63275-9900-5), c) 25 grams (NDC 63275-9900-4), Distributed by B&B Pharmaceuticals, Inc. 800-499-3100
by B & B Pharmaceuticals, Inc.
- Reason
- cGMP deviations: Presence of foreign material (Teflon)introduced at the production level.
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 14, 2022Historical recordClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 50, packaged in a) 1.5 fl. oz. (44 mL) tottles, UPC: 087052727338; b) 2 Fl. OZ. (59 mL) tubes, UPC: 08705272732; c) 4 FL. OZ. (118 mL) tubes, UPC: 087052727345, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144
by Filltech USA, LLC
- Reason
- Microbial contamination of non-sterile products: positive test for yeast and bacteria.
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 14, 2022Historical recordClass II
Dermatone (avobenzone, homosalate, octisalate, and octocrylene) Sunscreen Lotion Fragrance Free, SPF 30, package in 1.5 fl. oz. (44 mL) tottles, Distributed By: Beaumont Products, Inc. Kennesaw, GA 30144, UPC 020908422698
by Filltech USA, LLC
- Reason
- Microbial contamination of non-sterile products: positive test for yeast and bacteria.
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Oxycodone and Acetaminophen Tablets, USP 10 mg*/325 mg 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-046-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Phentermine Hydrochloride Capsules, USP 15mg, 100-count bottles, Distributed by: Aurobindo Phama USA, Inc. Dayton, NJ 08810, NDC 13107-105-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Mirtazapine Tablets, USP 15mg, 30-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 13107-031-34
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Simvastatin Tablets, USP 40mg 90-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-053-90
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Levetiracetam Tablets USP 750 mg 120-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. 279 Princeton-Hightstown Road East Windsor, NJ 08520, NDC 65862-247-08
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/60 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-060-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/30 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-059-99
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Acetaminophen and Codeine Phosphate Tablets, USP, 300 mg/15 mg, 100-count bottles, Rx Only, Distributed by: Aurobindo Pharma USA, Inc., Dayton, NJ 08810, NDC 13107-058-01
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 8, 2020Historical recordClass II
Losartan Potassium Tablets, USP, 25 mg, Rx only, a) 30 ct. (NDC 60429-316-30) b) 90ct. (NDC 60429-316-90) c) 1,000 ct. (60429-316-10) bottles, GSMS Incorporated, Manufactured by Arrow Pharm (Malta) Ltd., Packaged by GSMS Incorporated, Camarillo, CA 93012, USA
by Golden State Medical Supply Inc.
- Reason
- CGMP Deviations: Impurity for N-nitroso-N-methyl-4-aminobutryric Acid (NBMA) detected in active ingredient (API) used to manufacture finished products.
- Published
- April 22, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: March 25, 2024Historical recordClass II
Gabapentin Capsules, USP 100mg 1,000-count bottles, Rx only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65862-198-99
by Aurobindo Pharma USA Inc.
- Reason
- CGMP Deviations: Products were manufactured in a processing area in which water leakage was observed
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: January 6, 2021Historical recordClass I
Mountain Rose Inc. dba Mountain Rose Herbs
- Product
- Kudzu Root (Pueraria montana var. lobata), This product was…
- Reason
- Salmonella
- Published
- April 22, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 23, 2022Historical recordClass I
Tetracycline HCL Capsules, USP, 250 mg, 100-count Bottle, Rx Only, Manufactured for: Heritage Pharmaceuticals Inc. East Brunswick NJ 08816. NDC 23155-017-01
by Avet Pharmaceuticals, Inc.
- Reason
- Failed Dissolution Specifications: Out of specification result during long term testing in Tetracycline HCl capsules.
- Published
- April 15, 2020
- Distribution
- Nationwide
View recall →
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions.
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