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.

5201–5225 of 21589

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
13 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 (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-0201-2022·2021-11-10
Medtronic Neuromodulation Clinician Programmer Application Software Anomaly Recall
Medtronic recalled the Clinician Programmer Application (CPA) model A610 due to a potential software anomaly. Affected versions 3.0.1048, 3.0.1057, 3.0.1062, and 3.0.1081 have been distributed worldwide. No illnesses or injuries have been reported.
Product
Clinician Programmer Application (CPA) model A610 Clinician Software Application
Category
Medical Device
Distribution
Distributed nationwide
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
1 state
ModerateFDA (Devices)·Z-0202-2022·2021-11-10
Aspiration Syringe Kit MVSK60 Inadvertently Shipped with OUS Labeling
MicroVention's Aspiration Syringe Kit (REF: MVSK60) was labeled for international distribution but inadvertently shipped to U.S. customers. The affected lot (H2146461) was distributed to Alabama, Nevada, and New York.
Product
Aspiration Syringe Kit, REF: MVSK60
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0085-2022·2021-11-10
Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications
Dr. Reddy's Laboratories is recalling 696 bottles of Ezetimibe and Simvastatin Tablets (10 mg/40 mg) distributed nationwide due to failed excipient specifications and the presence of foreign tablets in bottles.
Product
EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0185-2022·2021-11-10
Flexor Check-Flo Introducer recalled for misplaced radiopaque marker
Cook Inc. is recalling one lot of Flexor Check-Flo Introducers due to a manufacturing defect where the radiopaque marker band may be positioned incorrectly, affecting visualization during medical procedures.
Product
Flexor Check-Flo Introducer, Introducer Set, RPN KCFW-6.0-35-45-RB, GPN G09908 The introducer sheath incorporates a hydrophilic coated Flexor shaft with a hemostasis valve and is provided with a dilator.
Category
Medical Device
Distribution
17 states
ModerateFDA (Food)·F-0092-2022·2021-11-10
Dr. Berg Nutritionals Liquid Vitamin D with Zinc Dietary Supplement Recalled for Mold and Yeast Contamination
Health & Wellness Center, Inc. is recalling Dr. Berg Nutritionals Liquid Vitamin D with Zinc Dietary Supplement due to mold and yeast levels that exceed product specifications.
Product
Dr. Berg Nutritionals, Liquid Vitamin D with Zinc Dietary Supplement ( Liquid Vitamin D ), Individual 1 FL OZ bottle (with no secondary packaging), Glass bottle. The label of the Liquid Vitamin D product includes the following storage instructions: Store in a cool, dark plac
Category
Food
Distribution
0 states
ModerateFDA (Drugs)·D-0082-2022·2021-11-10
Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin Tablets (10 mg/20 mg) nationwide because the product was manufactured using an excipient that failed conductivity specifications.
Product
EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0084-2022·2021-11-10
Dr. Reddy's Ezetimibe and Simvastatin Tablets Recalled for Failed Excipient Specifications
Dr. Reddy's Laboratories is recalling Ezetimibe and Simvastatin 10 mg/40 mg tablets because an excipient used in manufacturing failed conductivity specifications. The recall affects 11,590 bottles of 30-count and 3,585 bottles of 90-count packages distributed nationwide.
Product
EZETIMIBE AND SIMVASTATIN — EZETIMIBE AND SIMVASTATIN (EZETIMIBE AND SIMVASTATIN)
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-0077-2022·2021-11-03
Afassco Pain Free Plus X-Strength Tablets Recalled for Failed Stability
Ultra Seal Corporation is recalling Afassco Pain Free Plus X-Strength Pain Reliever tablets nationwide due to out-of-specification results for Salicylic Acid, a related compound of Aspirin, indicating failed stability testing.
Product
Afassco Pain Free Plus X-STRENGTH PAIN RELIEVER (Acetaminophen 250 mg/Aspirin 250 mg/Caffeine 65 mg) tablets, 2 Tablets/package, Packaged in 12,000 Packets/Case, PO# 19540, Mfg. for: Afassco Minden, NV 89423 (Shipping Label)
Category
Drug
Distribution
Distributed nationwide
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
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
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 (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 (Devices)·Z-0172-2022·2021-11-03
Septal Occluder Devices Recalled for Incorrect Expiration Date Labeling
W L Gore & Associates recalls GORE CARDIOFORM SEPTAL OCCLUDER devices labeled with a 3-year expiration date when the actual shelf life is 2 years. The mislabeling affects 15 units distributed across the United States and internationally.
Product
REF/Catalogue Number GSX0030H, GORE CARDIOFORM SEPTAL OCCLUDER 30 mm Diameter, Catheter Working Length 75 cm, Delivery Profile 10 Fr, STERILE EO, Rx Only, UDI: 00733132648948 *Not distributed within the US
Category
Medical Device
Distribution
47 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-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-0068-2022·2021-11-03
Loratadine-D Extended-Release Tablets Recalled for Failed Moisture Limits
Sun Pharmaceutical Industries is recalling 22,752 blister packs of Loratadine-D Extended-Release Tablets (10mg/240mg) distributed nationwide due to failed moisture limits. The affected lot is AC14635 with expiration date 12/2022.
Product
LORATADINE AND PSEUDOEPHEDRINE SULFATE — LORATADINE AND PSEUDOEPHEDRINE SULFATE (LORATADINE AND PSEUDOEPHEDRINE SULFATE)
Category
Drug
Distribution
Distributed nationwide
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-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-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 (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