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.

1726–1750 of 3531

ModerateFDA (Food)·F-0323-2023·2023-02-08
Vitamin B Complex dietary supplement recalled due to undeclared niacin
Professional Complementary Health Formulas, LLC recalls Vitamin B Complex dietary supplement (lot 1092715) due to undeclared niacin affecting 299 bottles distributed nationwide.
Product
Vitamin B Complex packaged in white plastic bottle labeled in part, "***PROFESSIONAL FORMULAS COMPLEMENTARY HEALTH Vitamin B Complex DIETARY SUPPLEMENT 60 Capsules***Supplement Facts Serving Size: One Capsule***Vitamin B1 (as thiamine Hcl) 80mg 6667% Vitamin B2 (as riboflavin) 80
Category
Food
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0337-2023·2023-02-08
Limited Edition Winter Mint Chocolate Premier Protein Shake Recalled for Spoilage Risk
Niagara Bottling is recalling Limited Edition Winter Mint Chocolate Premier Protein Shakes distributed in CA, GA, and OH because they did not undergo proper processing and may be spoiled.
Product
Limited Edition Winter Mint Chocolate Premier Protein 30g Protein High Protein Shake 11.5oz (340mL) UPC 00643843801498 packaged in plastic bottles in full wrap lithograph packed in a cardboard case, 12 packages per case
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0260-2023·2023-02-08
Global Care 70% rubbing alcohol products recalled for cGMP manufacturing violations
Global Care 70% Alcohol Ethyl Rubbing Alcohol, distributed in Puerto Rico, has been voluntarily recalled by Frenda Corporation due to manufacturing compliance deviations. The recall affects 12,130 bottles in multiple package sizes.
Product
Global Care 70% Alcohol Ethyl Rubbing Alcohol, packaged in a) 32 FL OZ (946 mL) UPC 8 70373 01323 1; b) 16 FL OZ (473 mL) UPC 8 70373 01332 3; c) 1 Gallon (128 FL OZ) 3785.41 mL UPC 8 70373 01330 4, Dist. By Target Price, Inc. Catano, PR
Category
Drug
Distribution
0 states
ModerateFDA (Drugs)·D-0261-2023·2023-02-08
Homeopathic Topical Cream Recalled for Manufacturing Process Deviations
DISCOVERY PHARMA LLC voluntarily recalled 21,892 tubes of Conzerol zero molluscum contagiosum topical cream distributed in California, Florida, and Washington due to current good manufacturing practice deviations.
Product
Conzerol zero molluscum contagiosum, Homeopathic treatment for Molluscum Contagiosum, Topical Cream, Net weight 0.78 oz (22g) tube, UPC 8 60322 00180 8, Manufactured by: Dr. Retter EC Warszawska 17, 05-075 Warszawa Poland
Category
Drug
Distribution
3 states
ModerateFDA (Drugs)·D-0258-2023·2023-02-08
Easy Clean Ethyl Alcohol Bottles Recalled Due to Manufacturing Deviations
Frenda Corporation voluntarily recalled 44,140 bottles of Easy Clean 75% Ethyl Alcohol sold in Puerto Rico due to manufacturing practice deviations.
Product
Easy Clean 75% Ethyl Alcohol, packaged in a) 1 Gallon (128 fl. oz.) UPC 8 91857 00045 5; b) 16 fl. oz. (473 mL) UPC 8 91857 00055 4; c) Rubbing Alcohol 10 fl. oz. (296 mL) UPC 8 91857 00044 8, Manufactured by Frenda Corporation Trujillo Alto, PR 00976
Category
Drug
Distribution
0 states
ModerateFDA (Devices)·Z-1016-2023·2023-02-01
Intraoperative PTH Test Kits Recalled Due to High Result Variability
Future Diagnostics recalled STAT-IntraOperative-Intact-PTH immunoassay kits due to high coefficient of variability in test results. 342 kits were distributed worldwide.
Product
Future Diagnostics STAT-IntraOperative-Intact-PTH (STAT-IO-I-PTH) Immunoassay kit REF 4K-IPT-00. in vitro diagnostic.
Category
Medical Device
Distribution
7 states
ModerateFDA (Drugs)·D-0172-2023·2023-02-01
FDA Recalls Fentanyl Injection Solution for Underfilled Cassettes
OurPharma LLC is recalling 768 cassettes of FentaNYL Citrate injection solution due to underfilled units. The affected product was distributed in Illinois and Missouri.
Product
FentaNYL Citrate 2.5mg/50mL (50mcg/mL) Injection Solution, Preservative-Free IV Injection 50mL Cassette, Rx Only, OurPharma, LLC, 2512 S. City Lake Rd., Fayetteville, AR 72701, NDC 73013-1001-01.
Category
Drug
Distribution
2 states
ModerateFDA (Devices)·Z-1020-2023·2023-02-01
AirQ3 Intubating Laryngeal Airway Recall: Orogastric Tube Size Labeling Discrepancy
SunMed is recalling 43,290 AirQ3 Self Pressurizing Intubating Laryngeal Airways due to a sizing discrepancy between device labeling and actual channel dimensions. Clinicians may need to use a smaller-diameter gastric catheter than indicated.
Product
AirQ3 Self Pressurizing ILA with Automatic Cuff Inflation and GA Size REF Number 0.0 60005 0.5 60055 1.0 60105 1.5 60155 2.0 60205 3.0 60305 4.0 60405
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1019-2023·2023-02-01
Air-Q3 intubating laryngeal airway size labeling discrepancy between IFU and device
SunMed's Air-Q3 intubating laryngeal airway devices have a discrepancy between the Instructions For Use and the printed text on the device regarding orogastric tube sizes, which could cause confusion when placing gastric catheters.
Product
Air-Q3 AirQ3 Standard ILA with Manual Cuff Inflation and GA Size REF Number 0.0 50005 0.5 50055 1.0 50105 1.5 50155 2.0 50205 3.0 50305 4.0 50405
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0176-2023·2023-02-01
Drug Recall: S2 Racepinephrine Inhalation Solution Short Fill
Nephron Sc Inc recalls approximately 925,920 vials of S2 Racepinephrine Inhalation Solution due to short fill. Affected lots may contain less medication than labeled.
Product
S2 — S2 (RACEPINEPHRINE HYDROCHLORIDE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0174-2023·2023-02-01
Clobetasol Propionate Cream recalled due to subpotent drug
Lupin Pharmaceuticals is recalling Clobetasol Propionate Cream 0.05% nationwide because stability testing revealed insufficient active ingredient in the affected lot.
Product
CLOBETASOL PROPIONATE — CLOBETASOL PROPIONATE (CLOBETASOL PROPIONATE)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0170-2023·2023-02-01
Metoprolol Succinate Tablets Recalled for Failed Dissolution Specification
Ascend Laboratories is recalling 6,336 bottles of Metoprolol Succinate Extended-Release Tablets, 50 mg, distributed nationwide and in Puerto Rico, due to failed dissolution specification.
Product
METOPROLOL SUCCINATE — METOPROLOL SUCCINATE (METOPROLOL SUCCINATE ER TABLETS)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-1013-2023·2023-02-01
Baxter ELI 380 Electrocardiograph Recalled After Misdirected Shipment
Baxter recalls one ELI 380 electrocardiograph that was shipped to a customer in Texas by mistake on 26 October 2022. The device was intended for a pilot program only.
Product
Baxter Electrocardiograph, ELI 380 -DCS21
Category
Medical Device
Distribution
1 state
ModerateFDA (Food)·F-0277-2023·2023-01-25
Klosterman Baking Company Breads Recalled for Insanitary Handling Conditions
Klosterman Baking Company is recalling breads and buns distributed in Indiana, Ohio, and Tennessee due to products being held under insanitary conditions.
Product
Breads: Milk & Egg product 8098 Clear Bag Buns 8 2.5 oz. Milk & Egg product 8099 Clear Bag Buns 8 2.65 oz Milk & Egg product 8608 Clear Bag Buns 6 1.5 oz.
Category
Food
Distribution
3 states
ModerateFDA (Food)·F-0269-2023·2023-01-25
Klosterman Cuban Bread Recalled Due to Insanitary Storage Conditions
Klosterman Baking Company recalls 109,343 loaves of Cuban bread held under insanitary storage conditions. The affected products were distributed in Indiana, Ohio, and Tennessee between December 12 and 16.
Product
Breads: Cuban product 8506 Clear Bag Loaf 1 16 oz.
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0148-2023·2023-01-25
Ophthalmic solution recalled due to manufacturing quality control deviations
Akorn, Inc. is recalling 1,752 bottles of Olopatadine HCL Ophthalmic Solution, USP 0.1% nationwide due to manufacturing quality control deviations. Lot 1L03A with expiration 10/31/2023 is affected.
Product
Olopatadine HCL Ophthalmic Solution, USP 0.1%, Antihistamine and Redness Reliever, 5 mL (0.17 FL OZ) per bottle, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-308-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0150-2023·2023-01-25
Antihistamine eye drops recalled due to manufacturing process deviations
Akorn, Inc. is recalling 163,996 bottles of Olopatadine HCl Ophthalmic Solution 0.1% due to manufacturing process deviations. Affected lot numbers expire from October through December 2023.
Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL (0.17 FL OZ) per bottle, Antihistamine and Redness Reliever, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 51407-499-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0265-2023·2023-01-25
Blueberry Bagels Recalled Due to Insanitary Storage Conditions
Klosterman Baking Company recalls Old World brand blueberry bagels due to products being held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee.
Product
Breads: Blueberry product 9531 Old World Bagels 6 3 oz. Blueberry product 9541 Old World Bagels 6 4 oz.
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0142-2023·2023-01-25
Akorn recalls Levofloxacin eye drops due to manufacturing compliance issues
Akorn, Inc. is recalling Levofloxacin Ophthalmic Solution due to manufacturing process deviations. The voluntary recall affects 3,108 bottles distributed nationwide.
Product
Levofloxacin Ophthalmic Solution 0.5%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, Il 60045. NDC: 17478-106-10
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0267-2023·2023-01-25
Klosterman Baking Company cornmeal buns recalled due to insanitary storage conditions
Klosterman Baking Company is recalling cornmeal buns due to insanitary storage conditions. About 109,343 units distributed in IN, OH, and TN between December 12-16 are affected. No illnesses have been reported.
Product
Breads: Cornmeal product 3630 Clear Bag Buns 12 100 g
Category
Food
Distribution
3 states
ModerateFDA (Drugs)·D-0151-2023·2023-01-25
Prescription eye drop recall due to manufacturing compliance issues
Akorn, Inc. is recalling Olopatadine HCl Ophthalmic Solution due to manufacturing process deviations. The nationwide voluntary recall involves 121,176 bottles distributed across the United States.
Product
Olopatadine HCl Ophthalmic Solution, USP 0.1%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. Marketed by: GSMS, Incorporated, Camarillo, CA 93012. NDC: 60429-957-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0146-2023·2023-01-25
Ofloxacin Ophthalmic Solution Recalled Nationwide for Manufacturing Quality Issues
Akorn, Inc. is recalling Ofloxacin Ophthalmic Solution 0.3% due to manufacturing quality deviations. The recall affects 65,006 bottles distributed nationwide.
Product
Ofloxacin Ophthalmic Solution, USP 0.3%, 5 mL per bottle, Rx Only, Manufactured by: Akorn, Inc., Lake Forest, IL 60045; Distributed by: MWI, Boise, ID 83705. NDC: 13985-602-05
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0155-2023·2023-01-25
Sodium Chloride Ophthalmic Ointment Recalled for Manufacturing Deviations
Akorn, Inc. has voluntarily recalled 524,506 tubes of Sodium Chloride Ophthalmic Ointment, USP 5%, nationwide due to Current Good Manufacturing Practice deviations.
Product
Sodium Chloride Ophthalmic Ointment, USP, 5%, Net Wt. 3.5 g (1/8 oz.) per tube, Manufactured by: Akorn, Inc., Lake Forest, IL 60045. NDC: 17478-622-35
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0283-2023·2023-01-25
Klosterman Rye Bread Recalled Due to Insanitary Holding Conditions
Klosterman Baking Company is recalling rye bread products held under insanitary conditions. Approximately 109,343 units were distributed to Indiana, Ohio, and Tennessee between December 12–16.
Product
Breads: Rye product 1495 Klosterman Retail UPC # 0005172100109 Loaf 1 16 oz. Rye product 1505 Clear Bag Loaf 1 32 oz. Rye product 1525 Klosterman Foodservice UPC # 0005172100456 Loaf 1 24 oz. Rye product 1545 Klosterman Retail UPC # 0005172100108 Loaf 1 16 oz. Rye product 1550
Category
Food
Distribution
3 states
ModerateFDA (Devices)·Z-0958-2023·2023-01-25
Abbott Alinity Reaction Vessels Recalled for Potential Contaminant
Abbott Laboratories recalled 70 cases of Alinity Reaction Vessels due to potential contamination that could affect optical performance. Units were distributed across multiple U.S. states.
Product
Alinity Reaction Vessels, REF: 06P1401, for use with Alinity i Systems; ARCHITECT Reaction Vessels
Category
Medical Device
Distribution
11 states