FDA Recall Terminated Historical recordClass II
Extra Strength (ES) PAIN RELIEVER (acetaminophen 500 mg) 2 tablet packets, Manufactured by Ultratab Laboratories, Inc.
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
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Recall totals
All FDA and USDA recalls in Public Health Trace, June 2012 to September 2026.
37,066
Total recall recordsAll FDA and USDA recalls in Public Health Trace9,786
Class I recallsReasonable probability of serious health consequences24,313
Class II recallsTemporary or medically reversible health consequences2,876
Class III recallsNot likely to cause adverse health consequencesQuick insights
A snapshot of the most notable patterns across all recorded FDA and USDA recalls.
Most recalled product100 vegetarian Fenugreek Capsules 90 count, 600mg, packaged in 150cc Amber Glass Packer with White Polypropylene Cap.
53 recalls
Most common hazardLack of Assurance of Sterility
2,072 recalls
Newest recallhttp://www.fda.gov/safety/recalls-market-withdrawals-safety-alerts/whole-foods-market-issues-allergy-alert-undeclared-egg-cabricharme-cheesePublished September 11, 2026
Download matching recalls as CSV
CSV exports include up to 5,000 matching rows (applying your current filters), not the full dataset if it's larger.
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A chart of recalls grouped by month.
Download CSVSummary (Year to date)
- 1,527 recalls have been announced year to date.
- Aug 2026 was 24% lower than the previous complete period (Jul 2026: 240).
- The highest complete period was Jun 2026 (297).
- Sep 2026 is incomplete and not included in the figures above.
- Complete data
- Incomplete
A bar chart of the total number of recalls in this dataset by recall class.
| Class | Recalls |
|---|---|
| Class II | 24,313 |
| Class I | 9,786 |
| Class III | 2,876 |
| Not Yet Classified | 2 |
| Class | Recalls |
|---|---|
| Class II | 24,313 |
| Class I | 9,786 |
| Class III | 2,876 |
| Not Yet Classified | 2 |
FDA Recall Terminated Historical recordClass II
CHLORESIN (acetaminophen 325mg, dextromethorphan HBr 15mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Manufactured For Afassco Inc. Minden NV 89423, NDC 51532-0107-2
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Maximum Strength Non Aspirin Pain Reliever/Fever Reducer (acetaminophen 500 mg) 2 tablet packets, Mfg. for: Advanced First Aid, Baltimore MD 21237, American Safety & First Aid, Osceola, IN 46561, NDC 67060-210-68
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
AERO TAB Cold Relief (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5mg) 2 tablet packets, Mfg. for: Aero Healthcare, Valley Cottage, NY 10989
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Cold Tablet Pain Reliever/Fever Reducer/Expectorant/Nasal Decongestant (acetaminophen 325 mg, Guaifenesin 200mg, Phenylephrine HCl 5 mg) 2 tablets per packet, Mfg, for Respond Industries and American First Aid, Mason, OH 45040
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Nasal & Sinus Decongestant (phenylephrine HCl 5mg) 2 tablets per packet, Mfd. for Cintas First Aid & Safety, Mason OH 45040
- Reason
- cGMP deviations
- Published
- February 9, 2022
- Distribution
- Nationwide
FDA Recall Ongoing Historical recordClass II
Medroxyprogesterone Acetate Injection, IM, 150 mg/mL, packaged in 1 ml Single Dose Vial, RX Only, Ideal Pharmacy, 2333 Morris Ave, Union, NJ 07083
- Reason
- Lack of Assurance of Sterility
- Published
- February 9, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Doxylamine Succinate and Pyridoxine Hydrochloride Delayed-Release Tablets 10 mg/10 mg, 100-count bottle, Rx Only, Manufactured by: Actavis Laboratories FL, Inc., Fort Lauderdale, FL 33314, USA, Distributed by: Actavis Pharma, Inc., Parsippany, NJ 007045 USA, NDC 0591-2132-01
- Reason
- Failed Dissolution Specification: Dissolution results are below specification limits for the active ingredient
- Published
- February 9, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
CTx12 5000 Kit which contains 3 boxes of CariFree CTx4 GEl 5000 gel tubes. 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
- Reason
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
CariFree sample boxes, contains one tube of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321.
- Reason
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
CTx36 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and six boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
- Reason
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
CTx26 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and two bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle an two boxes of 4fl.oz. Carifree CTx4 Treatment Rinse.
- Reason
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
CTx21 Kit, contains three tubes of CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and three bottles of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
- Reason
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
CTx7 Kit, contains one tube CariFree CTx4 Gel 5000, 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 and one bottle of CariFree CTx3 Rinse, Mint Anticavity Rinse, 16 fl oz. bottle.
- Reason
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass III
CariFree CTx4 GEl 5000 1.1% Neutral Sodium Fluoride Mint, 2 oz (57 g) Rx only NDC: 61578-205-01 Manufactured by Oral BioTech Albany, Oregon 97321 Distributed in 12-pk/cases
- Reason
- Subpotent Drug: Product contains less Sodium Fluoride than listed on product label.
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Proctofoam HC (hydrocortisone acetate 1% and pramoxine hydrochloride 1%) topical aerosol, 10 g aerosol containers, Rx Only, Distributed by Meda Pharmaceuticals Inc, Somerset, New Jersey 08873-1120, NDC 0037-6822-10.
- Reason
- cGMP deficiencies
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Metoprolol Succinate Extended-Release Tablets, USP 50 mg, 500-count bottle, Rx Only, Manufactured by: Alkem Laboratories Ltd., Mumbai - 400 013 INDIA. NDC 68001-501-03
- Reason
- Failed Dissolution Specifications
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Pioglitazone Tablets USP, 45 mg, 500 count bottles, Distributed by: Aurobindo Pharma USA, Inc., East Windsor, NJ -- NDC 57237-221-05
- Reason
- Superpotent and Failed Tablet/Capsule Specifications
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Trypan Blue 0.03%, 0.5mL per syringe, Sterile Ophthalmic Solution for Injection Preservative Free, Single Use Syringe, For Intraocular Injection, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
FDA Recall Terminated Historical recordClass II
Vancomycin HCl Oral Solution (PF) 125mg / 2.5mL (50 mg/mL), 2.5 mL per syringe, Single Dose Syringe for Oral Use Only, Edge Pharma, LLC, 856 Hercules Dr., Colchester, VT 05446, NDC 05446-1348-01
- Reason
- CGMP Deviations
- Published
- February 2, 2022
- Distribution
- Nationwide
Data last updated:
Recall records are summarized from official FDA and USDA sources. Notices may be updated, reclassified, terminated, or withdrawn. Always review the linked official notice for the most current instructions. Read the full medical disclaimer.
