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.

5001–5025 of 21589

ModerateFDA (Drugs)·D-0390-2022·2022-01-26
Medique Pain-Off Tablets Recalled for Manufacturing Practice Violations
Medique Products is recalling Medique Pain-Off tablets nationwide after an FDA inspection found the products were not manufactured under Current Good Manufacturing Practices.
Product
Medique Pain-Off (Acetaminophen 250 mg, Aspirin (NSAID*) 250 mg, Caffeine 65 mg) Tablets, packaged in 2-count Tablets per Unit Dose Packet, packaged as a) 200-count Tablets (100 x 2) Unit Dose packets per carton, UPC 3 47682 22847 7, Reorder #22847; b) 500-count Tablets (250 x 2
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0376-2022·2022-01-26
Clobazam Oral Suspension Recalled for Failed Stability Specifications
VistaPharm is recalling Clobazam Oral Suspension 2.5 mg/mL due to failed stability specifications. The recall affects 18,456 bottles distributed nationwide.
Product
Clobazam Oral Suspension 2.5 mg/mL, 120 mL bottles, Rx only, Manufactured by: VistaPharm, Inc. Largo, FL 33771, NDC 66689-058-04
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0509-2022·2022-01-26
Medichoice Infant Heel Warmer recalled due to unapproved labeling changes
Philips is recalling 2,925,800 Medichoice Infant Heel Warmer units because labeling was modified beyond the scope of FDA clearance. The devices cannot be sold without new 510(k) approval.
Product
Medichoice Infant Heel Warmer, Reference # 989805643721 1079906
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0507-2022·2022-01-26
Heel Snuggler devices recalled for labeling changes without FDA approval
Philips North America recalled approximately 2.5 million Heel Snuggler units because labeling was modified after FDA clearance without obtaining updated regulatory approval.
Product
Heel Snuggler, Reference # 989805603411 99047
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0389-2022·2022-01-26
Physicians CARE Extra Strength Pain Reliever recalled for CGMP deviations
Medique Products is recalling Physicians CARE Extra Strength Pain Reliever tablets nationwide because they were not manufactured under Current Good Manufacturing Practices (CGMP), as determined by an FDA inspection.
Product
Physicians CARE Extra Strength PAIN RELIEVER [Acetaminophen, Aspirin (NSAID), and Caffeine], 250 mg, 250 mg, 65 mg, packaged as 100-count Tablets (50 Packets, 2 tablets each) per carton, Manufactured for: Acme United Corporation 55 Walls Dr, Fairfield, CT 06824, UPC 0 73577 90316
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0505-2022·2022-01-26
Medical Device Mattress Recalled for Labeling Non-Compliance with FDA Requirements
Philips is recalling 141,750 Infa-Therm Transport Mattresses because modified labeling does not comply with FDA clearance requirements. The devices cannot be distributed or sold without new FDA clearance.
Product
Infa-Therm Transport Mattress, Reference Number 989805616831 1015
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0385-2022·2022-01-26
CVS Health Allergy Relief D Tablets Recalled for Failed Dissolution
CVS Health Allergy Relief D Extended Release Tablets are being recalled because they failed to meet dissolution specifications. The recall affects 41,784 boxes distributed nationwide.
Product
CVS Health, Allergy Relief D, Fexofenadine HCl 60mg/Antihistamine Pseudoephedrine HCl 120mg/Nasal Decongestant, a) 20 Extended Release Tablets per box, UPC 050428436189, b) 30 Extended Release Tablets per box, UPC 050428290538, Distributed by CVS Pharmacy Inc., One CVS Drive, Wo
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0511-2022·2022-01-26
Aroma Meats Curry Leaf Powder Recalled for Unapproved Source
Aroma Meats LLC is recalling Curry Leaf Powder (Karevepaku Podi) 1/4 KG packages distributed in Oregon because the product was sourced from an unapproved supplier.
Product
Curry Leaf Powder (Karevepaku Podi), packaged in white plastic pouch, net wt. 1/4 KG (250 grams). No UPC. Labeled with Aroma Meats but has no address. The label is read in parts: "***CURRY LEAF POWDER (Karevepaku Podi)*** FRESH POWDERS***1/4 KG (250gms) ***AROMA MEATS***".
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0384-2022·2022-01-26
QC Quality Choice Fexofenadine/Pseudoephedrine Tablets Recalled for Failed Dissolution
Dr. Reddy's Laboratories is recalling QC Quality Choice Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg Extended-Release Tablets nationwide due to failed dissolution specifications that may reduce the medication's effectiveness.
Product
QC QUALITY CHOICE, Fexofenadine HCl 60mg and Pseudoephedrine HCl 120mg, Extended-Release Tablets, USP, Allergy & Congestion, 10 Tablets per box, NDC 63868-729-10, Distributed by C.D.M.A., Inc., 43157 W 9 Mile Rd, Novi, MI 48375, Made in India.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Devices)·Z-0506-2022·2022-01-26
Infant Heel Warmers Recalled for Unauthorized Labeling Changes
Philips North America is recalling 5,164,600 units of Infant Heel Warmers due to labeling changes made after FDA clearance without new approval. The devices cannot be distributed or sold without new FDA 510(k) clearance.
Product
Infant Heel Warmers w/strap, Reference # 989805603201 1223
Category
Medical Device
Distribution
Distributed nationwide
ModerateFDA (Drugs)·D-0374-2022·2022-01-26
Clobetasol Propionate Foam Recalled for CGMP Deviations
Ingenus Pharmaceuticals is recalling 45,173 cans of Clobetasol Propionate Foam, 0.05%, nationwide due to Current Good Manufacturing Practice (CGMP) deviations. This is a voluntary, FDA Class II recall.
Product
Clobetasol Propionate Foam, 0.05%, packaged in a) 50 g can (NDC 50742-304-50), and b) 100 g can (NDC 50742-304-01), Rx only, Manufactured for: Ingenus Pharmaceuticals, LLC, Orlando, FL 32839-6408.
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0510-2022·2022-01-26
Pulihora Paste Recalled Due to Unapproved Manufacturing Source
Aroma Meats LLC is recalling Pulihora Paste distributed in Oregon because the product was sourced from an unapproved facility. Consumers should not consume the product.
Product
Pulihora Paste is packaged in yellow plastic pouch. No weight listed. No UPC. Product is imported from Jamani Foods SRT 252 Sanathnagar, Hyderabad-500018, India.
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-0513-2022·2022-01-26
Fresh Banana Pickle Recall Due to Unapproved Source
Aroma Meats LLC is recalling Fresh Banana Pickle packaged in 500 gm clear plastic pouches because the product was sourced from an unapproved supplier. The product was distributed in Oregon.
Product
Fresh Banana Pickle is packaged in clear plastic pouch, net wt. 500 gm (1/2 KG). No UPC. Product is imported from Jampani SRT 252, Opp to Tata Motors, Sanath Nagar, Hyderabad, 500018, India. The label is read in parts: "***BANANA PICKLE ***Jampani Pickles ***SRT 252, Opp to Tata
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0391-2022·2022-01-26
Extra Strength Headache tablets recalled for CGMP manufacturing deviations
Medique Products is recalling Extra Strength Headache tablets nationwide after an FDA inspection found they were not manufactured under Current Good Manufacturing Practices.
Product
Extra Strength Headache (acetaminophen 250 mg, aspirin 250 mg, caffeine 65 mg) tablets, packaged in 2-count tablets per packet, Manufactured for: Lil' Drug Store Products, Inc., Cedar Rapids, IA 52404
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0512-2022·2022-01-26
Daliya Split Powder from unapproved source recalled by Aroma Meats
Aroma Meats LLC is recalling Daliya Split Powder (Putnala Podi) distributed in Oregon because the product was sourced from an unapproved supplier. Consumers should not use this product.
Product
Daliya Split Powder (Putnala Podi), packaged in white plastic pouch, net wt. 1/2 KG (500 gms). No UPC. Labeled with Aroma Meats but has no address. The label is read in parts: "***DALIYA SPLIT POWDER (Putnala podi pdr) ***FRESH POWDERS*** 1/2KG (500gms)***AROMA MEATS***".
Category
Food
Distribution
1 state
ModerateFDA (Food)·F-0518-2022·2022-01-26
Mango Pickle (Avakai) Recalled Due to Unapproved Source
Aroma Meats LLC is recalling Mango Pickle (Fresh Avakai) packaged in 500-gram white plastic pouches distributed in Oregon because the product comes from an unapproved source.
Product
Mango Pickle (Fresh Avakai) packaged in white plastic pouch, net wt. 1/2 KG (500 grams). No UPC. Label has no firm name and no address. The label is read in parts: "***AVAKAI (MANGO PICKLE) *** 1/2 KG (500 GMS)***".
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0382-2022·2022-01-26
Dr. Reddy's Fexofenadine/Pseudoephedrine Tablets Fail Dissolution Specification
Dr. Reddy's Laboratories is recalling Fexofenadine HCl 60 mg and Pseudoephedrine HCl 120 mg Extended-Release Tablets because the tablets failed to meet dissolution specifications, which may affect the drug's effectiveness.
Product
Dr. Reddys, Fexofenadine HCl 60 mg & Pseudoephedrine HCl 120 mg Extended-Release Tablets USP, a) 10 tablets per box, UPC 343598823355, b) 20 tablets per box, UPC 343598823140, c) 30 tablets per box, UPC 343598823317, Distributed by: Dr. Reddy's Laboratories, Inc. Princeton, NJ 08
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0515-2022·2022-01-26
Mango Ginger Pickle from Unapproved Source Recalled
Aroma Meats LLC is recalling Mango Ginger Pickle (Fresh Mamidi Allam) packaged in 500-gram white plastic pouches because the product was sourced from an unapproved manufacturer. The product was distributed in Oregon.
Product
Mango Ginger Pickle (Fresh Mamidi Allam) was packaged in white plastic pouch, net wt. 1/2 KG (500 grams). No UPC. Labeled with Aroma Meats name but has no address. The label is read in parts: "***FRESH MAMIDI ALLAM ***(MANGO GINGER PICKLE)***1/2 KG (500GMS) ***".
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0387-2022·2022-01-26
Lexette Topical Foam Recall Due to Dispensing Defects
Mayne Pharma is recalling Lexette (halobetasol propionate) Topical Foam 0.05% due to manufacturing defects that cause the product to either not dispense or dispense liquid instead of foam. The recall affects 17,113 canisters distributed nationwide.
Product
Lexette (halobetasol propionate) Topical Foam, 0.05% 50 g canisters, Rx ONLY, Distributed by: Mayne Pharma Greenville, NC 27834, NDC 51862-604-50
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0506-2022·2022-01-26
ZOCALO Aji Limo Dried Chili Pods Recalled for Mold Contamination
Power Selles Imports is recalling ZOCALO AJI LIMO DRIED CHILI PODS due to the presence of mold on the product. The affected product was distributed across multiple states.
Product
ZOCALO AJI LIMO DRIED CHILI PODS- ORGANIC, Dried Aji Peppers for consumer consumption. Product is vacuum sealed in plastic bag. Net weight per bag 1.25 oz (35 g), 6 bags per case. Product of Peru. UPC 8 32924 00879 0. The product label is read in parts: "***ZOCALO gourmet *** O
Category
Food
Distribution
11 states
ModerateFDA (Food)·F-0517-2022·2022-01-26
Aroma Meats Ginger Pickle Recalled for Unapproved Source
Aroma Meats LLC is recalling Ginger Pickle (Fresh Allam Avakai) packaged in 500-gram white plastic pouches distributed in Oregon because the product was from an unapproved source.
Product
Ginger Pickle (Fresh Allam Avakai) was packaged in white plastic pouch, net wt. 1/2KG (500 grams). No UPC. Some packages have no firm name and some packages say Aroma Meats name but has no address. The label is read in parts: "***FRESH PICKLE GINGER PKL ***Ingredients: Fresh Gi
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0381-2022·2022-01-26
Fexofenadine/Pseudoephedrine tablets recalled for failed dissolution
Dr. Reddy's Laboratories is recalling Kroger Allergy Relief-D tablets (fexofenadine HCl 60mg/pseudoephedrine HCl 120mg) due to failed dissolution specifications. Approximately 11,064 boxes distributed nationwide are affected.
Product
FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI — FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI (FEXOFENADINE HCL AND PSEUDOEPHEDRINE HCI)
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0509-2022·2022-01-26
Cilantro Sweet Pickles Recalled Due to Unapproved Source
Aroma Meats LLC is recalling Cilantro Sweet Pickles (Kollimini Sweet) distributed in Oregon because the product was sourced from an unapproved supplier.
Product
Cilantro Sweet Pickles (Kollimini Sweet) is packaged in White plastic pouch. Net wt. 1/2 KG (500grams). No UPC. Labeled with Aroma Meats name but has no address.
Category
Food
Distribution
1 state
ModerateFDA (Drugs)·D-0373-2022·2022-01-26
Brinzolamide Ophthalmic Suspension recalled for defective container caps
Teva Pharmaceuticals is recalling Brinzolamide Ophthalmic Suspension 1% due to defective container caps. The notch in the dropper cap could break off and block dispensing of the medication.
Product
Brinzolamide Ophthalmic Suspension, USP 1%, packaged as a)10 ml dropper bottles (NDC 0591-2127-79), and b) 15 ml dropper bottles (NDC 0591-2127-12), Rx Only, Manufactured in India By: Indoco Remedies Limited Verna, Goa - 403722, India, Manufactured For: Teva Pharmaceuticals USA,
Category
Drug
Distribution
Distributed nationwide
ModerateFDA (Food)·F-0516-2022·2022-01-26
Jackfruit Mango Pickle from Unapproved Source Recalled
Aroma Meats LLC is recalling Jackfruit Mango Pickle (Fresh Panasapottu) distributed in Oregon because the product was sourced from an unapproved supplier.
Product
Jackfruit Mango Pickle (Fresh Panasapottu) was packaged in white plastic pouch, net wt. 1/2KG (500 grams). No UPC. The label is read in parts: "***FRESH PANASAPOTTU (JACKFRUIT Mango Pickle)***1/2KG (500 GMS)***".
Category
Food
Distribution
1 state