FDA Recall
TerminatedTerminated: July 13, 2021Historical recordClass III
Amlodipine Besylate USP 10 mg Tablets, 1000-count bottles, Rx Only, Manufactured by: Cipla Ltd., Verna Goa, India, Manufactured for: Cipla USA, Inc. 1560 Sawgrass Corporate Parkway, Suite 130, Sunrise FL 33323 UPC 369097128159, NDC 69097-128-15
by InvaGen Pharmaceuticals, Inc.
- Reason
- Subpotent Drug: One lot of product does not meet the product specification for Assay test at 3 month long term stability condition.
- Published
- October 17, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: February 24, 2020Historical recordClass II
Pantoprazole Sodium Delayed-Release Tablets, USP, 40 mg*, 90-count bottle, Rx only, Manufactured by: Jubilant Generics Ltd., Roorkee - 247661, India; Marketed by: Jubilant Cadista Pharmaceuticals Inc., Salisbury, MD 21801; NDC 59746-284-90.
by Jubilant Cadista Pharmaceuticals, Inc.
- Reason
- Discoloration: Presence of dark discoloration or brown spots on the edges of the tablets.
- Published
- October 17, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: May 8, 2020Historical recordClass II
Glipizide XL (glipizide) extended-release tablets 5 mg 500-tablet bottle, Rx only Distributed by: Greenstone LLC. Peapack, NJ 07977 --- NDC 59762-0541-2
by Pfizer Inc.
- Reason
- CGMP Deviations; rejected product was used to manufacture final bulk lot
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 12, 2018Historical recordClass II
Sarap Asian Fusion
- Product
- Ube Cookies & Cream (cookies); A Sarap Asian Fusion Product…
- Reason
- Undeclared wheat, soy lecithin, and milk
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 12, 2018Historical recordClass II
Sarap Asian Fusion
- Product
- Matcha Chocolate (cookies); A Sarap Asian Fusion Product;…
- Reason
- Undeclared wheat and soy lecithin
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 12, 2018Historical recordClass II
Sarap Asian Fusion
- Product
- Black Sesame White Chocolate (cookies); A Sarap Asian Fusio…
- Reason
- Undeclared wheat, soy lecithin, and milk
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 12, 2018Historical recordClass II
Sarap Asian Fusion
- Product
- Miso Milo Chocolate (cookies); A Sarap Asian Fusion Product…
- Reason
- Undeclared wheat and soy lecithin
- Published
- October 17, 2018
- Distribution
- Online to customers in AE, AK, AL, AR, A…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 6, 2018Historical recordClass II
WHOLE FOODS MARKET
- Product
- 365 Everyday Value Brand White Corn Chips, Salted NET WT 20…
- Reason
- Product may contain undeclared milk.
- Published
- October 17, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2022Historical recordClass III
treatNOW ABILIFY (aripiprazole) / ABILIFY MAINTENA 400-mg (aripiprazole) for extended release injectable suspension. Kit contents 2 packs Abilify Tablets 10 mg (14 day supply) plus 1 Abilfy Maintena Vial Kit.Rx only. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850 USA Marketed by: Lundbleck, Deerfield, IL 60015 USA Bar Code VialKit-59148-10Tabs-02
by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Reason
- Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: March 9, 2022Historical recordClass III
treatNOW ABILIFY (aripiprazole) and ABILIFY MAINTENA (aripiprazole) 400MG for extended release injectable suspension. Kit Contents: 2 packs ABILIFY Tablets 10mg (14 day supply) plus 1 ABILIFY MAINTENA Pre-filled Dual Chamber Syringe Kit. Rx only. Not for sale or reimbursement. Distributed and Marketed by: Otsuka America Pharmaceutical, Inc. Rockville, MD 20850. Marketed by: Deerfield, IL 60015 USA. Bar Code DCSKit-59148-10Tabs-01
by Otsuka Pharmaceutical Development & Commercialization, Inc.
- Reason
- Labeling Not Elsewhere Classified: Physician sample kits/cartons of treatNOW Abilify are mislabeled. Product name is misspelled, storage instructions are missing and contents of kits may be incorrectly labeled on the outer packaging of the co-packaged kit.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 4, 2020Historical recordClass I
robaxin-750 (methocarbamol tablets, USP), 750 mg, 100-count bottle, Rx Only, Distributed by: Endo Pharmaceuticals Inc., Malvern, PA 19355; Manufactured by: Kremers Urban Pharmaceuticals Inc., a subsidiary of Lannett Company, Inc., Seymour, IN 47274; NDC 52244-449-10.
by Endo Pharmaceuticals, Inc.
- Reason
- Labeling: Incorrect Instructions: Dosage information on the immediate container label incorrectly states "Two to four tablets four times daily." rather than the correct dosage of "Two tablets three times daily."
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: February 17, 2023Historical recordClass II
Nystatin and Triamcinolone Acetonide Cream, USP, 100,000 units/gm & 1 mg/gm, packaged in a) 15 g tube (NDC 43598-431-44), b) 30 g tube (NDC 43598-431-30), c) 60 g tube (NDC 43598-431-60), Rx only, Distributor: Dr. Reddy's Laboratories, Inc. 107 College Road East, Princeton, NJ - 08540 Rx Only Made in India
by Dr. Reddy's Laboratories, Inc.
- Reason
- Failed stability specifications - An out of specification result was observed for the test parameter : composition of Nystatin during stability testing.
- Published
- October 10, 2018
- Distribution
- Nationwide
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FDA Recall
TerminatedTerminated: July 7, 2025Historical recordClass II
Thyroid Powder 25kg/drum, US Pharmacopoeia, Sichuan Friendly Pharmaceutical Co., LTD, Production Address: No. 680, Hongpai Road, Dongxing District, Neijiang City Sichuan, China Tel:+886 832 2240082/2240298. NDC 7807-0170-11
by Sichuan Friendly Pharmaceutical Co.,Ltd.
- Reason
- CGMP Deviations: Thyroid Powder has inconsistent levels of the active ingredients levothyroxine and liothyronine.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: June 26, 2020Historical recordClass II
Elelyso (taliglucerase alfa) for injection, 200 units/vial, single-use vial, Rx only, Distributed by Pfizer Labs, Division of Pfizer Inc, NY, NY 10017, NDC 0069-0106-01
by Pfizer Inc.
- Reason
- Lack of assurance of sterility -Reports of loose metal ferrule crimps on vials for injection. The entire cap either lifted or dislodged while attempting to flip off the orange color plastic button.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: August 31, 2020Historical recordClass II
NeoRelief for Muscle Cramping & Restlessness Homeopathic Topical Gel, packaged in a) 4 ml sample packs and b) Net Wt. 2.0 oz (56.7g) bottles, BioLyte Laboratories - Grand Rapids, MI 49534, NDC 58368-002-02
by BioLyte Laboratories, LLC
- Reason
- CGMP Deviations: finished product produced with active ingredients recalled by the manufacturer, King Bio Inc., due to water contamination issues that could potentially affect the quality of this product.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
TerminatedTerminated: May 1, 2019Historical recordClass II
Clozapine Orally Disintegrating Tablets, 12.5 mg, 100-count bottles, Rx only, Teva Pharmaceuticals USA, Inc., North Wales, PA 19454, NDC 0093-5416-01 Yellow, round, flat-faced, beveled-edge, unscored tablet. Debossed with 13 on one side and plain on the other side.
by Teva Pharmaceuticals USA
- Reason
- Failed Disintegration Specifications: Out-of-specification disintegration test result obtained during routine stability testing.
- Published
- October 10, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: August 4, 2020Historical recordClass I
Neighbors LLC
- Product
- Crazy About Cookies***GLUTEN FREE CHOCOLATE CHIP COOKIE DOUG…
- Reason
- Undeclared almonds on the labeling
- Published
- October 10, 2018
- Distribution
- Products were distributed in the followi…
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2018Historical recordClass II
Lamb Weston Inc
- Product
- Murry's Hash Brown Potato Patties, packaged in cardboard tra…
- Reason
- Hash brown product, sold under brand Murry's is recalled because the product may contain small fragments of hard, clear plastic.
- Published
- October 10, 2018
- Distribution
- CA, FL, IA, MA, MD, OH, PA, and TX.
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: November 5, 2018Historical recordClass II
Wismettac Asian Foods (USA) dba Nishimoto Trading Co Ltd
- Product
- EVERYBURGER - Burger-Shaped Chocolate Cookies: NET WT. 2.32…
- Reason
- The ingredient list and allergen information are partially covered by a nutrition sticker. Allergens of wheat, milk and eggs are visible.
- Published
- October 10, 2018
- Distribution
- Multiple states
View recall →
FDA Recall
🇺🇸 United States
TerminatedTerminated: December 14, 2018Historical recordClass II
Lamb Weston Inc
- Product
- Formed Hash Brown Patties, packaged in cardboard trays cover…
- Reason
- Hash brown product, sold under brands Brookshire's, Market Pantry, Breakfast, and Stater Bros, are recalled because the product may contain small fragments of hard, clear plastic.
- Published
- October 10, 2018
- Distribution
- CA, FL, IA, MA, MD, OH, PA, and TX.
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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