Severity 2 of 5

Moderate recalls

Minor labeling or packaging issue, or a voluntary precautionary recall. Risk of harm is low but real — follow the manufacturer's instructions.

What “moderate” means here

Severity 2 (Moderate) recalls cover minor labeling errors, low-risk contamination, and voluntary precautionary recalls. The agency's own classification is typically FDA Class III, or the issue is something like incomplete instructions or a small UPC mismatch where the product itself is safe but doesn't meet documentation requirements. Use the same brand-name product safely; follow the manufacturer's instructions for return or exchange if you want a refund.

The full rubric is on the methodology page. Severity is computed deterministically from the agency’s own classification plus the source text — no editorial vibes.

21551–21575 of 21633

ModerateFDA (Drugs)·D-1379-2012·2012-06-20
Physicians Total Care Recalls Arthrotec 75 Tablets Due to Broken Tablets
Physicians Total Care is recalling specific lots of Arthrotec 75 tablets because they may contain broken tablets. The recall affects products distributed in North Carolina and Kentucky.
Product
Arthrotec 75 (diclofenac sodium and misoprostol) tablets, 75 mg/200 mcg, a) 30-count tablets per bottle (NDC 54868-4165-1); b) 60-count tablets per bottle (NDC 54868-4165-0); Rx only, Mfg. By: G.D. searle LLC Div Pfizer, New York, NY 10017; Repacked & distributed by: Physicians…
Category
Drug
Distribution
2 states
ModerateFDA (Food)·F-1425-2012·2012-06-20
Crown Prince Canned Oysters Recalled for Insanitary Conditions
Crown Prince Inc is recalling 8 oz cans of Whole Boiled Oysters because they were prepared under insanitary conditions, posing a potential health risk.
Product
Canned oysters. Crown Prince Whole Boiled Oysters, 8 oz. Each case is 8oz/12.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1427-2012·2012-06-20
Crown Prince Canned Smoked Oysters Recalled for Insanitary Conditions
Crown Prince Inc is recalling 3-ounce cans of Natural Smoked Oysters in Olive Oil because they were prepared under insanitary conditions.
Product
Canned oysters. Crown Prince Natural Smoked Oysters in Olive Oil, 3 oz. Each case is 3oz/18.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1803-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon Corporation is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. PORT-A-CATH Tray Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1798-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits. The syringes are used to maintain the patency of indwelling catheter lumens.
Product
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 10 Units per mL, 3mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1429-2012·2012-06-20
King & Prince Seafood Recalls Breaded Oysters for Insanitary Conditions
King & Prince Seafood is recalling Mrs. Friday's Gourmet Breaded Oysters because they were prepared or packed under insanitary conditions, posing a potential health risk.
Product
1) Mrs.Friday's brand, Gourmet Breaded Oysters, Medium 18-25 CT, Ready to Fry, Net Wt 2.5 lbs (1.13 kg). 2) Mrs.Friday's brand, (Canada) Gourmet Breaded Oysters, Medium, Ready to Fry, Net Wt 2.5 lbs (1.13 kg), Distributed by King & Prince Corp., Brunswick, GA 31521. Product is…
Category
Food
Distribution
13 states
ModerateFDA (Devices)·Z-1806-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon is voluntarily recalling Heparin Lock Flush Syringes and kits containing them due to a related recall of VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1407-2012·2012-06-20
Bliss Bros. Dairy Ice Cream Recalled for Aflatoxin Contamination
Bliss Bros. Dairy is recalling 3-gallon containers of Chocolate Peanut Butter Cookie Dough Ice Cream due to elevated aflatoxin levels in the liquid peanut butter.
Product
Bliss Bros. Dairy Chocolate Peanut Butter Cookie Dough Ice Cream, 3-gallon round paperboard,: frozen
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1801-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes Due to Voluntary Manufacturer Action
Vygon Corporation is voluntarily recalling multiple lots of VY Flush Heparin Lock Flush Syringes and related kits nationwide.
Product
Vygon VY(TM)Flush Heparin Lock Flush Syringes, 100 Units per mL, 5mL in a 10mL Flush Syringe, 30 syringes per box, Rx only Prefilled syringes are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1421-2012·2012-06-20
Campbell's Oyster Stew Recalled for Potential Contamination
Campbell Soup Company is recalling Campbell's Oyster Stew because it may have been prepared under insanitary conditions, posing a potential health risk.
Product
Campbell's Oyster Stew, Net Wt 10.5 oz (298g), Campbell Soup Company, Camden, NJ 08103-1701
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1400-2012·2012-06-20
Panera Honey Walnut Cream Cheese Spread Recalled for Ingredient Labeling Error
Panera Bread LLC is recalling Honey Walnut Cream Cheese Spread because the ingredient statement was reversed with another product.
Product
Panera HONEY WALNUT CREAM CHEESE SPREAD, Reduced Fat, 8 0z Refrigerated
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1376-2012·2012-06-20
Ben Venue Recalls Midazolam HCl Injection Due to Potential Low Fill Volume
Ben Venue Laboratories is recalling Midazolam HCl Injection vials because some may have low fill volume. The recall covers 11,161 packs distributed nationwide and in Puerto Rico.
Product
Midazolam HCl Injection, 5 mg/mL, 1 mL single use vials, packaged in 10 x 1 mL single use vials per pack, Rx only, Manufactured by: Ben Venue Laboratories, Inc., Bedford, OH 44146; Manufactured for: Bedford Laboratories, Bedford, OH 44146, NDC 55390-138-01; UPC 3 55390-138-01…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1434-2012·2012-06-20
Chicken of the Sea Recalls Smoked Oyster Water for Sanitation Issues
Chicken of the Sea is recalling Pacific Pearl Smoked Oyster Water because the product was prepared under insanitary conditions that may have caused contamination.
Product
Pacific Pearl Smoked Oyster Water 12 units per case
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1805-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon Corporation is recalling Heparin Lock Flush Syringes and kits due to a voluntary recall of related VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. VAD ACCESS TRAY Kit Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1424-2012·2012-06-20
Daufuski Brand Boiled Oysters Recalled for Insanitary Conditions
Liberty Gold Fruit Company is recalling Daufuski Brand boiled oysters due to preparation under insanitary conditions that may have contaminated the product.
Product
Daufuski Brand boiled Oysters, 8 oz; Distributed by Liberty Gold Fruit, Inc.
Category
Food
Distribution
8 states
ModerateFDA (Drugs)·D-1381-2012·2012-06-20
Endo Pharmaceuticals Recalls Endocet Tablets Due to Foreign Tablet Contamination
Endo Pharmaceuticals is recalling specific bottles of Endocet 10 mg/650 mg tablets because some contained mixed 10 mg/325 mg tablets.
Product
Endocet (oxycodone and acetaminophen) tablets, USP, 10 mg/650 mg, 100-count tablets per bottle, Rx only, Manufactured for: Endo Pharmaceuticals Inc., Chadds Ford, PA, By: Novartis, Lincoln, NE 68501; NDC 60951-797-70.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1375-2012·2012-06-20
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 335,190 Daytrana patches because the delivery system may be miscalibrated or defective, affecting the ability to remove the release liner.
Product
Daytrana (methylphenidate) transdermal system patch, Delivers 10 mg over 9 hours (1.1 mg/hr), 1 patch per pouch (NDC 54092-552-01), packaged in 30-count patches per box (NDC 54092-552-30), Rx only, Manufactured for Shire US Inc., Wayne, PA 19087; by Noven Pharmaceuticals, Inc.…
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1422-2012·2012-06-20
Polar Whole Boiled Oysters Recalled for Insanitary Conditions
Milky Way Intl Trading Corp is recalling Polar Whole Boiled Oysters due to insanitary conditions that may have contaminated the product.
Product
Polar Whole Boiled Oysters, 8 oz. net weight, 12 cans/carton.
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1808-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and PICC Insertion Kits
Vygon is recalling Heparin Lock Flush Syringes and kits containing them due to a voluntary recall of similar syringes by the manufacturer.
Product
Churchill Medical Systems, Inc. A VYGON COMPANY PICC INSERTION TRAY Prefilled syringes included in the kit are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-1372-2012·2012-06-20
Noven Recalls Daytrana Patches Due to Defective Delivery System
Noven Pharmaceuticals is recalling 357,510 Daytrana (methylphenidate) patches because the delivery system may be miscalibrated or defective, affecting the ability to remove the release liner.
Product
DAYTRANA — DAYTRANA (METHYLPHENIDATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-1402-2012·2012-06-20
Stahl's Famous Original Bakery Cutout Cookies Recalled for Undeclared Ingredients
JDS Bakery LLC is recalling 80 packages of 14-oz Stahl's Famous Original Bakery Cutout Cookies because the labels fail to declare specific sub-ingredients.
Product
Stahl's Famous Original Bakery CUTOUT COOKIES 14oz. INGREDIENTS: Pastry Flour, Sugar, Shortening...Contains Wheat, Eggs, Milk and Soy.
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-1417-2012·2012-06-20
Napoleon Canned Smoked Oysters Recalled for Insanitary Conditions
The Napoleon Company is recalling canned smoked oysters prepared under insanitary conditions that may have rendered the product injurious to health.
Product
Napoleon canned, Smoked Oysters, Medium. Item no. 48-312. Net WT. per can is 3.66 oz (106 g). The UPC is 0 41253 00312 7. The product is labeled in parts: "***NAPOLEON***Medium***SMOKED OYSTERS***NET WT. 3.66 OZ (106 g)***INGREDIENTS: SMOKED OYSTERS, SOYA OIL…
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-1802-2012·2012-06-20
Vygon Recalls Heparin Lock Flush Syringes and Kits
Vygon is recalling heparin lock flush syringes and kits due to a manufacturer recall of VY Flush Heparin Lock Flush Syringes.
Product
Churchill Medical Systems, Inc. A VYGON Company PICC LINE TRAY Kit Prefilled syringes included in the tray kit are used to maintain the patency of indwelling catheter lumens
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1791-2012·2012-06-20
Philips Brilliance iCT and iCT SP CT Systems Software Update Recall
Philips is issuing a software update for Brilliance iCT and iCT SP systems to address non-conformances that do not result in unacceptable hazards.
Product
The Brilliance iCT and iCT SP are Computed Tomography X-Ray Systems intended to produce cross-sectional images of the body by computer reconstruction of x-ray transmission data taken at different angles and planes. These devices may include signal analysis and display…
Category
Medical Device
Distribution
22 states
ModerateFDA (Food)·F-1432-2012·2012-06-20
Chicken of the Sea Recalls Oysters Due to Insanitary Conditions
Chicken of the Sea is recalling specific oyster products because they were prepared or packed under insanitary conditions, posing a potential health risk.
Product
1) Chicken of the Sea Whole Oysters, 12 units per case, 8oz., UPC 4800000267; 2) Ace of Diamonds Whole Oysters 24 units per case, UPC 7760015508
Category
Food
Distribution
Distributed nationwide