FDA Recall
🇺🇸 United States
TerminatedTerminated: March 30, 2020Historical recordClass I
Meijer
- Product
- Fresh From Meijer diced hard boiled eggs sold by weight from…
- Reason
- Possible L. mono contamination in hard boiled eggs
- Published
- February 19, 2020
- Distribution
- Products were offered for sale at the sa…
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FDA Recall
TerminatedTerminated: December 16, 2022Historical recordClass III
Pioglitazone and Metformin Hydrochloride Tablets, USP 15 mg/500 mg, Rx Only, 60-count bottle, Manufactured for Macleods Pharma USA, Inc. Plainsboro, NJ 08536, Manufactured by: Macleods Pharmaceuticals Ltd. Baddi, Himachal Pradesh, India, NDA 33342-176-09
by Macleods Pharma Usa Inc
- Reason
- Subpotent Drug: Out of specification assay result, below specification, for two lots of Pioglitazone And Metformin Hydrochloride Tablets.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 29, 2022Historical recordClass II
Atorvastatin Calcium Tablets, USP, 10 mg*, 90-count bottle, Rx Only, Manufactured for: Biocon Pharma Inc., Iselin, NJ 08830-3009 USA; Manufactured By: Graviti Pharmaceuticals Pvt. Ltd., Telangana -502307, INDIA; NDC 70377-027-11.
by Graviti Pharmaceuticals Private Limited
- Reason
- Presence of Foreign Tablets/Capsules: Customer complaint that one 20 mg Atorvastatin Calcium Tablet was present in a bottle labeled as and containing eight-nine Atorvastatin Calcium Tablets, USP 10 mg.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 10, 2020Historical recordClass II
Desmopressin Acetate Tablets, 0.2 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2465-01
by Teva Pharmaceuticals USA
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: December 10, 2020Historical recordClass II
Desmopressin Acetate Tablets, 0.1 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories, Inc. Fort Lauderdale, FL 33314 USA, Distributed by: Actavis Pharma, Inc. Parisppany, NJ 07054 USA, NDC 0591-2464-01
by Teva Pharmaceuticals USA
- Reason
- GMP Deviations: Product bottle may be absent of desiccant.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: January 8, 2021Historical recordClass III
Clonidine Hydrochloride Tablets, USP 0.1mg, Rx Only, 100-count bottle, Manufactured by: Unichem Laboratories Ltd. Pilerne Ind. Estate, Pilerne Bardez, Goa 403 511 India. Manufactured for: Unichem Pharmaceuticals (USA), Inc. East Brunswick, NJ 08816. NDC 29300-135-01
by UNICHEM PHARMACEUTICALS USA INC
- Reason
- Failed Impurities/Degredation Specifications: This recall is initiated as a precautionary measure due to potential migration of Benzophenone at very low level into product from container label.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 29, 2021Historical recordClass II
Olmesartan Medoxomil Tablets 20 mg, Rx Only, 90 Tablets per Bottle, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA, Distributed by: Ascend Laboratories, LLC Parsippany, NJ 07054, NDC 67877-446-90.
by Ascend Laboratories LLC
- Reason
- cGMP Deviations; Olmesartan Medoximil Tablets 20 mg was released in error with alternate API source prior to filing and approval of Prior Approval Supplement.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 27, 2021Historical recordClass III
Minocycline Hydrochloride Extended-Release Tablets, USP, 105 mg*, 30-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 India, Distributed by: Ascend Laboratories, LLC, Parsippany, NJ 07054, NDC 67877-438-30.
by Ascend Laboratories LLC
- Reason
- Failed Dissolution Specifications: low out of specification results for dissolution testing.
- Published
- February 12, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: June 3, 2021Historical recordClass II
Nystatin Oral Suspension, USP 100,000 units per mL Cherry/Peppermint Flavor, 16 fl oz (473 mL) Rx Only, pai, Pharmaceutical Associates, Inc. Greenville, SC 29605. NDC 0121-0810-16
by Pharmaceutical Associates Inc
- Reason
- Subpotent: Out of specification for assay at the 12-month time point.
- Published
- February 5, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: April 26, 2021Historical recordClass III
Montelukast Sodium Chewable Tablets, 5 mg, 90-count bottles, Rx Only, Manufactured for : Macleods Pharma USA, Inc. Plainsboro, NJ Manufactured by: Macleods Pharmaceuticals Ltd Baddi, Himachal Pradesh, India NDC 33342-111-10
by Macleods Pharma Usa Inc
- Reason
- Failed Dissolution Specifications: testing revealed low out of specification result in one lot of product
- Published
- February 5, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: November 6, 2020Historical recordClass II
Walgreens Acne Cleansing Bar, Benzoyl Peroxide 10%, NET WT 4 oz (113 g), 1 bar per carton, Distributed By: Walgreen Co., 200 Wilmot Road, Deerfield, IL 60015, NDC: 0363-0137-11
by Shandex Personal Care Manufacturing Inc.
- Reason
- Presence of Foreign Substance; Metal contaminant visible in product (screen wire from manufacturing).
- Published
- February 5, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: May 1, 2020Historical recordClass I
Jeni's Splendid Ice Creams LLC
- Product
- Jeni's Dairy Free Cold Brew with Coconut Cream Pints frozen…
- Reason
- May contain undeclared milk allergen
- Published
- February 5, 2020
- Distribution
- Product distributed to the following sta…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: July 6, 2022Historical recordClass II
Healthy Food Ingredients, LLC
- Product
- Organic IntegriPure Cold Milled Flaxseed, 50 lb Net Wt. and…
- Reason
- Product is being recalled due to detection of an unapproved herbicide.
- Published
- February 5, 2020
- Distribution
- CA, CO, UT. EXPANDED February 2020: M…
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 28, 2020Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Caramel Sea Salt Sandwich…
- Reason
- Potential to contain undeclared milk and coconut.
- Published
- February 5, 2020
- Distribution
- Nationwide
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FDA Recall
🇺🇸 United States
TerminatedTerminated: January 28, 2020Historical recordClass I
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Dark Chocolate Peppermint Sandwich Cremes…
- Reason
- Potential to contain undeclared milk.
- Published
- February 5, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: September 8, 2021Historical recordClass III
methylPREDNISolone Sodium Succinate For Injection, USP, 500 mg*/vial, Rx Only, Mfd by: HIKMA FARMACEUTICA (PORTUGAL), SA; Dist by: WEST-WARD, Eatontown, NJ 07724, NDC 0143-9850-01.
by Hikma Pharmaceuticals USA Inc.
- Reason
- Labeling: Incorrect Instructions: Vial label incorrectly instructs healthcare professional to reconstitute product with 16 mL rather than the correct volume of 8 mL of Bacteriostatic Water for Injection with Benzyl Alcohol.
- Published
- January 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 12, 2023Historical recordClass II
Entropic Labs SARM RAD-140, 20mg Capsules, 30-count bottles, Entropic Labs UPC#: 651074545302
by Tuscano and Delucia Group (DBA Entropic Labs)
- Reason
- Marketed Without An Approved NDA/ANDA: product contains Selective Androgen Receptor Modulators (SARMs)
- Published
- January 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 21, 2023Historical recordClass II
NETSPOT, (kit for the preparation of Ga 68 dotatate injection) 40 mcg dotatate, For Intravenous Use Only, Rx Only, Manufactured for: Advanced Accelerator Applications USA, Inc. by Gipharma S.r.l. Strada Crescentino snc, 13040 Saluggia (Vc), Italy, NDC 69488-001-40.
by Advanced Accelerator Applications USA, Inc.
- Reason
- Defective Container: loose aluminum cap crimp for the dilution buffer vial present in the NETSPOT Kit (vial 2).
- Published
- January 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 5, 2023Historical recordClass II
Ranitidine Tablets, USP 300 mg a). 15-count bottles (NDC 70934-287-15), b). 90-count bottles (NDC 70934-287-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: October 5, 2023Historical recordClass II
Ranitidine Tablets, USP 150 mg , a). 4 count bottle (NDC 70934-017-04), b). 20-count bottle (NDC 70934-017-20), c). 24-count bottle (NDC 70934-017-24) d). 30-count bottle (NDC 70934-017-30) e). 90-count bottle (NDC 70934-017-90), Rx Only, Repackaged by: Northwind Pharmaceuticals North Brenheim, NY 12131.
by Denton Pharma, Inc.
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 29, 2020
- Distribution
- Nationwide
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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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