FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
Reichel Foods Inc.
- Product
- Pro2Snax To The Max snack tray containing Sliced Apples, Har…
- Reason
- Products are being recalled due to Listeria monocytogenes contamination.
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wayfare Health Foods LLC
- Product
- Plant Based WayFare Butterscotch Pudding Organic Dairy Free,…
- Reason
- Product is recalled due to consumer complaints for bloating of package, off flavors (sourness, tart), and textural issues (grittiness, lumpiness).
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wayfare Health Foods LLC
- Product
- Plant Based WayFare Vanilla Pudding Organic Dairy Free, Item…
- Reason
- Product recalled due to consumer complaints for bloating of package, off flavors (sourness, tart), and textural issues (grittiness, lumpiness).
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass II
Wayfare Health Foods LLC
- Product
- Plant Based WayFare Chocolate Pudding Organic Dairy Free, It…
- Reason
- Product recalled due to consumer complaints for bloating of package, off flavors (sourness, tart), and textural issues (grittiness, lumpiness).
- Published
- January 15, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
MYORISAN (isotretinoin capsules, USP), 20mg, packaged in 30-count Capsules (3 x 10 Prescription Packs) per box, Rx only, Distributed by: VersaPharm Inc. - An Akorn Company, Lake Forset, IL 60045; NDC 61748-302-13.
by Akorn, Inc.
- Reason
- Unit Dose Mispackaging: Customer complaint that a carton labeled as Myorisan 20 mg Capsules, USP erroneously contained one 10-count blister card of the 40 mg product in addition to two 10-count blister cards of the 20 mg product.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Bimatoprost Ophthalmic Solution, 0.03%, For Use in the Eyes Only, Sterile, Rx Only, 7.5 mL bottle, Manufactured by: Lupin Limited, Pithampur (M.P.), INDIA, NDC: 68180-429-03.
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Impurities/Degradation Specifications: Out-of-specification result observed in any other individual impurity.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Silver Bullet, Get Bigger and Harder, Works in Minutes, Lasts for Days, 10 male enhancement capsules in blister foil package, 725mg per capsule, Distributed by Silver Bullet Ltd, Golden Springs, CO, USA, UPC: 610877392698.
by Natures Rx
- Reason
- Marketed Without an Approved NDA/ANDA; Product contains undeclared active ingredient - Sildenafil.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Ranitidine Syrup (Ranitidine Oral Solution USP), 15 mg/mL, 150 mg/10 mL per cup, Rx Only, Distributed by: American Health Packaging, Columbus, Ohio. (a) Case of 50 cups (NDC 60687-260-69) (b) Case of 40 cups (NDC 60687-260-23 (c) Unit Dose Cup (NDC 60687-260-69)
by American Health Packaging
- Reason
- CGMP Deviations: Presence of NDMA impurity detected in product.
- Published
- January 8, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol; Oestriol] Micronized, USP, CAS 50-27-1, packaged in a) 1 G glass bottles, b) 5 G glass bottles, c) 25 G glass bottles, d) 100 G glass bottles, e) 500 G glass bottles, and f) 1 KG plastic bottles, Rx Only, Spectrum Chemical Mfg Corp., Gardena, CA 90248.
by Spectrum Laboratory Products
- Reason
- Subpotent Drug: Supplier indicated assay results did not meet specifications.
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 4 mg added to 250 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 254.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 8 mg added to 500 mL 5% Dextrose Injection USP (16 mcg per mL) Total Volume 508.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
NORepinephrine Bitartrate 8 mg added to 250 mL 5% Dextrose Injection USP (32 mcg per mL) Total Volume 258.00 mL Viaflex Bag, High Alert, Rx Only, PharMEDium Services LLC., 12620 W Airport Blvd #130 Sugar Land, TX 77478.
by PharMEDium Services, LLC
- Reason
- Subpotent Drug
- Published
- January 1, 2020
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Gabapentin Capsules, USP 100 mg, Rx Only, Distributed by: Aurobindo Pharma USA, Inc. Dayton, NJ 08810, NDC 65682-198-99
by AuroMedics Pharma LLC
- Reason
- Presence of Foreign Tablets/Capsules: One Losartan/HCTZ tablet was found in Gabapentin 1000 count bottles..
- Published
- December 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass I
Levetiracetam Oral Solution 100mg/mL, 473 mL (16 fl. oz.) Bottles, Rx Only, Distributed by: Lannett Company, Inc. Philadelphia, PA 19136, NDC 54838-0548-80
by Lannett Company, Inc.
- Reason
- Microbial Contamination of Non-sterile Products: Out-of-specification results obtained for Total Aerobic Microbial Count.
- Published
- December 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
Memantine Hydrochloride Extended-release Capsules, 28mg, packaged in a) 90-count bottles (NDC 68180-249-09 and b) 500-count bottles (NDC 68180-249-02); Rx only, Manufactured for: Lupin Pharmaceuticals, Inc., Baltimore, Maryland 21202; Manufactured by: Lupin Limited, Pithampur (M.P.)-454 775, INDIA
by Lupin Pharmaceuticals Inc.
- Reason
- Failed Dissolution Specifications: High out of specification result observed at stability studies.
- Published
- December 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass III
VCF Vaginal Contraceptive Foam, a) can, 13 applications per can, Net wt. 0.6 oz (17g). NDC 52925-312-14, b) case pack with 36 cans in a nested container. Net wt 0.6 oz (17g) per can. NDC 52925-312-06, Distributed By: Apothecus Pharmaceutical Corp. Oyster Bay, NY 11771.
by Apothecus Pharmaceutical Corp.
- Reason
- Defective Delivery System: canister unit exhibiting propellant leakage or loss, rendering the product and canister unusable
- Published
- December 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
Terminated
Historical recordClass II
Estriol, USP (Micronized) 1 g, 5 g, 25 g, 100 g, 2000 g, 1 kg, containers, Packed by Medisca Inc., Plattsburgh, NY 12901, USA
by Medisca, Inc.
- Reason
- Failed Impurities/Degradation Specifications
- Published
- December 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Single meal Chicken Rosemary Paleo UPC 232361000003 sold i…
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- December 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Chicken Orange Sesame sold on the hot bar
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- December 25, 2019
- Distribution
- Nationwide
View recall →
FDA Recall
🇺🇸 United States
Terminated
Historical recordClass I
WHOLE FOODS MARKET
- Product
- Bulgogi Beef with Vegetables sold on the hot bar
- Reason
- Possible contamination with Listeria monocytogenes
- Published
- December 25, 2019
- 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.
Read the full medical disclaimer.