FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Buddy's Kitchen Inc
- Product
- Huevos Rancheros Style Benedict with Seasoned Black Beans, I…
- Reason
- Buddy's Kitchen is recalling several products in response to the McCain Foods recall due to potential Listeria or Salmonella contamination.
- Published
- November 7, 2018
- Distribution
- AZ, CA, GA, IL, MO, NJ, OH, OK.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Buddy's Kitchen Inc
- Product
- Mushroom & Thyme Flatbread Pizza, Item 70610. Net Weight 7.…
- Reason
- Buddy's Kitchen is recalling several products in response to the McCain Foods recall due to potential Listeria or Salmonella contamination.
- Published
- November 7, 2018
- Distribution
- AZ, CA, GA, IL, MO, NJ, OH, OK.
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Forager Project LLC
- Product
- Forager Project Organic Protein Plant Shake Nuts & Vanill…
- Reason
- Undeclared allergen; tree nuts (almonds)
- Published
- November 7, 2018
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
GOURMET SPECIALTIES INC.
- Product
- Fresh Herb Basil 62/4oz., LB 2489, 135/5Bulk, 24/8oz., 12/1…
- Reason
- Potential Cyclospora cayetanensis contamination.
- Published
- November 7, 2018
- Distribution
- U.S. distribution to the following: CA,…
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
FOODSTIRS
- Product
- Foodstirs Modern Baking; Organic Minute Mug Cake Mix Celebr…
- Reason
- Individual pouches of Organic Minute Mug Cake Mix Celebration Confetti 4-pack do not declare milk as an allergen. The correct allergen statement is on the outer carton.
- Published
- November 7, 2018
- Distribution
- Distributors in CA, TX, OR, AZ, OH, IL,…
View recall →
FDA Recall
Terminated
Historical recordClass II
Bumetanide Tablets, USP, 2 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0542-11
by Upsher Smith Laboratories, Inc.
- Reason
- Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Bumetanide Tablets, USP, 1 mg, 100-count bottle, Rx only, Manufactured by: Upser-Smith Laboratories, LLC, Maple Grove, MN 55369, NDC 0832-0541-11
by Upsher Smith Laboratories, Inc.
- Reason
- Failed impurities/ degradation specifications: Product is Out of Specification for an unspecified degradation product.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Prednisolone and Gatifloxacin Ophthalmic Solution, 1%/0.5%, 3 mL dropper bottle, Rx Only, 31818 US Hwy 19N, Palm Harbor, FL 34684
by Promise Pharmacy LLC
- Reason
- Presence of precipitate
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Lidocaine 1% + Epinephrine 1:100,000 (MDV) INJ SOL, 50 mL per glass vial, Rx only, 340 West State Street, Unit 9, Athens, OH 45701. NDC 7073197450
by RXQ Compounding LLC
- Reason
- Subpotent drug: During testing of the retention sample, the firm discovered that the product was sub-potent.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Metoprolol Succinate Extended Release Tablets, USP 50 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 62037-831-01
by Teva Pharmaceuticals USA
- Reason
- Failed dissolution specifications: Out-of-Specification dissolution test result obtained during routine stability testing.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
PIO&METFORMIN 15/1000 mg Tab 1 (Pioglitazone and Metformin XT) tablets, Takeda Brand Name: Actoplus Met XR (Pioglitazone and metformin HCl extended -release) tablets, 15 mg/1000 mg, packaged in a fiber drum, Application Holder Takeda Pharmaceuticals, U.S.A. Inc. One Takeda Parkway, Deerfield, IL 60015
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Published
- October 31, 2018
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended Release Tablets 1000 mg, 90-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2412-19
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Published
- October 31, 2018
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended Release Tablets 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL, 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054 , NDC 00591-2720-60
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Published
- October 31, 2018
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Metformin Hydrochloride Extended Release Tablets, 500 mg, 100-count bottle, Rx only, Manufactured by: Actavis Laboratories, FL Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054, NDC 00591-2411-01
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Published
- October 31, 2018
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Fortamet (metformin HCl) extended release tablets, 1000 mg, 60-count bottle, Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Shionogi Inc., Florham Park, NJ 07932, NDC 59630-575-60
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Published
- October 31, 2018
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Paliperidone Extended Release Tablets 9 mg, packaged in a) 30-count bottle(NDC 0591-3695-30) , b) 90-count bottle (NDC 0591-3695-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Published
- October 31, 2018
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Paliperidone Extended Release Tablets 3 mg, packaged in a) 30-count bottle(NDC 0591-3693-30), b) 90-count bottle (NDC-0591-3693-19), Rx only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 07054
by Teva Pharmaceuticals USA
- Reason
- Defective Delivery System: There is a potential for some tablets to be missing the laser drilling which might affect drug release.
- Published
- October 31, 2018
- Distribution
- Product was distributed throughout the U…
View recall →
FDA Recall
Terminated
Historical recordClass II
Meropenem for Injection, USA (I.V.), 1 gram/vial, 25 vials per carton, Sterile, Rx Only, Manufactured for: Hospira, Inc., Lake Forest, IL 60045, USA. NDC carton: 0409-3506-01; NDC vial: 0409-3506-11
by Pfizer Inc.
- Reason
- Lack of assurance of sterility: loss of container integrity.
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Cidofovir injection 375 mg/mL (75 mg/mL) vial Injection, 5 mL vials, Rx Only, Mfg. By Emcure Pharmaceutical Ltd Hinjawadi, Pune, India, Mfg for: Heritage Pharmaceuticals Inc. UPC 323155216388, NDC 23155-216-31
by Heritage Pharmaceuticals, Inc.
- Reason
- Lack of Assurance of Sterility: complaints received about dried powder on the outside of the bottle
- Published
- October 31, 2018
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Fluocinolone Acetonide Topical Solution, USP 0.01%, 60ml Bottle, Manufactured for: Lupin Pharmaceutical, Inc. Baltimore, MD 21202 Manufactured by: Novel Laboratories, Inc. Somerset, NJ 08873. NDC 43386-069-60
by LUPIN SOMERSET
- Reason
- Failed Impurities/Degradation Specifications:Out of specification result noticed for total impurities observed during stability analysis
- Published
- October 31, 2018
- 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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