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.

3151–3175 of 3531

ModerateFDA (Food)·F-0159-2022·2021-11-10
Ivar's Clam Chowder Recalled for Plastic Fragment Contamination
Ivar's Kettle Classic Clam Chowder with Uncured Bacon is being recalled due to the presence of plastic fragments in the product. The recall affects approximately 14,968 sleeves distributed across thirteen Midwestern states.
Product
Ivar's Kettle Classic Clam Chowder With Uncured Bacon, Item #1952, Costco Item #1270666. The soup is refrigerated and packaged in 24 oz. clear plastic cups, in a double pack surrounded by a printed paperboard sleeve (2/24 cups per sleeve). Retail package's UPC 0 30383 19649 6.
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-0075-2022·2021-11-10
Yang Wu International Asian Pears Recalled for Pesticide Contamination
Yang Wu International Inc is recalling Asian Pears (YW Brand, 5Kg cases, Lot YF21008) distributed in California and Pennsylvania after the California Department of Pesticide Regulation found the pesticide Phorate at 0.055 ppm, a level determined to be a health hazard.
Product
Asian Pears 5Kg, YW Brand; 14 pears per case
Category
Food
Distribution
2 states
ModerateFDA (Food)·F-0107-2022·2021-11-10
Picket Fence Creamery Orange Pineapple Ice Cream Recalled for Undeclared Yellow #6
Picket Fence Creamery L.L.C. is recalling Orange Pineapple ice cream sold in Iowa because it contains undeclared Yellow #6, a color additive that may affect consumers with sensitivity to artificial dyes.
Product
Picket Fence Creamery, Woodward, IA, Orange Pineapple ice cream, in Quarts, Pints, and 1/2 Pints
Category
Food
Distribution
0 states
ModerateFDA (Food)·F-0090-2022·2021-11-10
Starbucks Doubleshot Espresso canned coffee recall due to sealing defect
PepsiCo is recalling Starbucks Doubleshot Espresso canned coffee products due to inadequate sealing that may lead to premature spoilage. The recall affects approximately 85,956 cases distributed nationwide.
Product
Starbucks Doubleshot Espresso, Espresso & Light Cream, 6.5 FL OZ UPC 012000008801
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0088-2022·2021-11-10
Irbesartan 300 mg tablets recalled for impurity in active ingredient
Lupin Pharmaceuticals is recalling Irbesartan 300 mg tablets due to the detection of N-nitrosoirbesartan impurity in the active pharmaceutical ingredient. The recall affects approximately 119,544 bottles distributed nationally.
Product
IRBESARTAN — IRBESARTAN (IRBESARTAN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0089-2022·2021-11-10
Starbucks Doubleshot Espresso canned coffee recalled for sealing defect
PepsiCo is recalling Starbucks Doubleshot Espresso and Espresso & Cream canned coffee products because inadequate sealing may cause premature spoilage.
Product
Starbucks Doubleshot Espresso, Espresso & Cream, 6.5 FL OZ UPC 012000001772
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0168-2022·2021-11-03
GORE CARDIOFORM Septal Occluder Labeled with Incorrect Expiration Date
W L Gore & Associates is recalling GORE CARDIOFORM Septal Occluder devices labeled with a 3-year expiration date instead of the correct 2-year date. Mislabeling could result in use of devices beyond their intended safe lifespan.
Product
REF/Catalogue Number GSXE0025, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617647 *Not distributed within the US
Category
Medical Device
Distribution
47 states
ModerateFDA (Drugs)·D-0070-2022·2021-11-03
PainAway II Acetaminophen/Aspirin/Caffeine Tablets Recalled for Failed Stability
Ultra Seal Corporation is recalling PainAway II tablets nationwide due to failed stability specifications. Testing found out-of-specification levels of Salicylic Acid, an aspirin-related compound.
Product
PainAway II (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets/pk, packaged in 12,000 Packets/Case, Material # 11161, Mfg. for Respond Industries First Aid, Mason, OH 45040 (Shipping Label)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0073-2022·2021-11-03
AERO Tab Pain Reliever Tablets Recalled for Failed Stability Specifications
Ultra Seal Corporation is recalling AERO Tab Pain Reliever tablets nationwide because out-of-specification results were found for Salicylic Acid, an Aspirin-related compound, indicating failed stability testing.
Product
AERO Tab PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets , 2 tablets Per Packet, Packaged in 10,000 Packets/Case, PO# 11938, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989 (Shipping Label )
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0074-2022·2021-11-03
North by Honeywell Pain Stopper Extra Strength tablets recalled for failed stability
Ultra Seal Corporation is recalling North by Honeywell Pain Stopper Extra Strength tablets nationwide because stability testing found out-of-specification results for Salicylic Acid, an aspirin-related compound.
Product
North by Honeywell PAIN STOPPER EXTRA STRENGTH (Acetaminophen 250 mg, Aspirin 250 mg, Caffeine 65 mg) tablets, 2 tablets per packet, Packaged in 5,000 Packets/Case, PO# B121242, Item# 853500-01, Dist. By Honeywell Safety Products USA, Smithfield, RI 02917
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0067-2022·2021-11-03
Sodium Selenite Injectable Solution Recalled for Sterility Concerns
Red Mountain Compounding Pharmacy is recalling Sodium Selenite 200mcg/ml injectable solution due to FDA inspection findings regarding lack of assurance of sterility. Approximately 494 patients in seven states received prescriptions for this product.
Product
SODIUM SELINITE 200MCG/ML FOR INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
ModerateFDA (Drugs)·D-0079-2022·2021-11-03
Rizatriptan Benzoate Tablets Recalled for Out-of-Specification Impurities
Macleods Pharma USA is recalling Rizatriptan Benzoate 5mg orally disintegrating tablets nationwide due to out-of-specification results in organic impurities testing. The affected lots are BRL2102A and BRL2103A with expiration date 04/2025.
Product
RIZATRIPTAN BENZOATE — RIZATRIPTAN BENZOATE (RIZATRIPTAN BENZOATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0029-2022·2021-11-03
Magnesium Chloride Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling Magnesium Chloride 200 mg/mL injection because FDA inspection raised concerns about lack of assurance of sterility. The product was distributed to approximately 494 patients in seven states.
Product
Magnesium Chloride, 200 mg/mL MDV INJ, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
ModerateFDA (Drugs)·D-0034-2022·2021-11-03
Cyclosporin 0.2% Oil Ophthalmic Suspension Recall Due to Sterility Assurance
Red Mountain Compounding Pharmacy is recalling Cyclosporin 0.2% Oil Ophthalmic Suspension because FDA inspection identified concerns about sterility assurance. The recalled drug was distributed to approximately 494 patients across multiple states.
Product
CYCLOSPORIN 0.2% OIL OPTH SUSP, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
ModerateFDA (Drugs)·D-0078-2022·2021-11-03
Rizatriptan Benzoate Tablets Recall Due to Out-of-Specification Impurities
MacLeods Pharma USA is recalling Rizatriptan Benzoate Film Coated Tablets (10 mg) due to out-of-specification test results in organic impurities testing. The recall affects multiple lot numbers distributed nationwide.
Product
RIZATRIPTAN — RIZATRIPTAN (RIZATRIPTAN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0075-2022·2021-11-03
Advance Formula Pain Reliever tablets recalled for failed stability specifications
Ultra Seal Corporation is recalling Advance Formula Pain Reliever tablets (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) distributed nationwide due to out-of-specification results for Salicylic Acid, an Aspirin-related compound.
Product
Advance Formula Pain Reliever (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 tablets Per Packet, Packaged in 12,000 Packets/Case, PO# 007564-00, Item# 1170, Mfg. for: Advanced First Aid, Baltimore, MD 21237; American Safety & First Aid, Osceola, IN 46561 (Shippin
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0163-2022·2021-11-03
Pneupac paraPac plus 300 ventilator kit recalled for duplicate serial number
Smiths Medical recalled two Pneupac paraPac plus 300 ventilator kits distributed in the UK that were labeled with the same serial number, preventing differentiation between the two units.
Product
Pneupac paraPac plus 300 ventilator kit, REF P300NGB
Category
Medical Device
Distribution
0 states
ModerateFDA (Devices)·Z-0166-2022·2021-11-03
GORE CARDIOFORM Septal Occluders Recalled for Incorrect Expiration Date
W. L. Gore & Associates is recalling GORE CARDIOFORM Septal Occluders labeled with incorrect 3-year expiration dates instead of 2-year dates. This labeling error affects devices distributed across the United States and internationally.
Product
REF/Catalogue Number GSX0025A, GORE CARDIOFORM SEPTAL OCCLUDER 25 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132631025 *Not distributed within the US
Category
Medical Device
Distribution
47 states
ModerateCPSC·22015·2021-11-03
Elektron BP-1 Power Handles Recalled for Fire and Burn Hazards
Elektron Power Handle BP-1 units can short circuit and overheat, creating fire and burn risks. Consumers should stop using them immediately and contact Elektron for a full refund.
Product
Elektron BP-1 Power Handles
Category
Consumer Product
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0076-2022·2021-11-03
Xpect First Aid Extra Strength Pain Away tablets recalled for failed stability specifications
Ultra Seal Corporation is recalling Xpect First Aid Extra Strength Pain Away tablets nationwide due to out-of-specification results for Salicylic Acid, a compound related to Aspirin, indicating failed stability testing.
Product
Xpect First aid Extra Strength PAIN AWAY (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, Material# 111519, Mfg. for: Cintas First Aid & Safety, Mason, OH 45040 (Shipping Label)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0167-2022·2021-11-03
GORE CARDIOFORM SEPTAL OCCLUDER Recalled for Incorrect Expiration Date Labeling
GORE CARDIOFORM SEPTAL OCCLUDER devices are recalled for labeling errors: 95 units marked with 3-year expiration instead of correct 2-year date. Affected units distributed across US and international locations.
Product
REF/Catalogue Number GSXE0020, GORE CARDIOFORM SEPTAL OCCLUDER 20 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132617630 *Not distributed within the US
Category
Medical Device
Distribution
47 states
ModerateFDA (Food)·F-0088-2022·2021-11-03
Food Grade Calcium Chloride Pellets Recalled for HDPE Contamination
Occidental Chemical Corporation is recalling food grade anhydrous calcium chloride pellets due to potential contamination with fragments of blue high-density polyethylene (HDPE). The recall affects 11,275 bags distributed to food processors and related industries.
Product
Food grade Anhydrous 94-97% Calcium Chloride Pellets, 50 lb. plastic bag
Category
Food
Distribution
5 states
ModerateFDA (Drugs)·D-0064-2022·2021-11-03
MIC/B12A/B6 Injection Recalled for Sterility Assurance Concerns
Red Mountain Compounding Pharmacy is recalling MIC/B12A/B6 injectable medication because FDA inspection identified concerns about sterility assurance. The recall affects 494 patients across seven states.
Product
MIC/B12A/B6 15/50/100 5MG/50MG/ML MDV, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
ModerateFDA (Drugs)·D-0060-2022·2021-11-03
Methylcobalamin injection recalled due to sterility assurance concerns
Red Mountain Compounding Pharmacy is recalling a methylcobalamin injectable solution after FDA inspection raised concerns about the lack of assurance of sterility.
Product
METHYLCOBALAMIN 12.5MG/ML MDV INJ SOLN, Rx only, Red Mountain Compounding Rx
Category
Drug
Distribution
7 states
ModerateFDA (Drugs)·D-0091-2022·2021-11-03
Gatifloxacin Ophthalmic Solution Recalled for Failed Stability Tests
Lupin Pharmaceuticals is recalling Gatifloxacin Ophthalmic Solution 0.5% due to failed water loss tests that may affect drug concentration. The recall affects 16,272 bottles distributed nationwide.
Product
Gatifloxacin Ophthalmic Solution, 0.5%, 2.5 mL bottle, Rx only, Manufactured by: Lupin Limited, Pithampur (M.P.) 454 775, INDIA, NDC 68180-435-01.
Category
Drug
Distribution
Distributed nationwide