CLASS II Drug recall · Reported 17 Apr 2019 · FDA Enforcement Report
Losartan Potassium # USP, 100 mg are white to off white recalled
H J Harkins is recalling Losartan Potassium # USP, 100 mg are white to off white, film coated, tear drop shaped, distributed in California. The recall was initiated on 4 Mar 2019 and the FDA has classified it as Class II.
Check your package
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
Recall details
- Recall number
- D-1083-2019
- FDA event ID
- 82574
- Recalling firm
- H J Harkins, Grover Beach, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 4 Mar 2019
- FDA classified
- 7 Apr 2019
- Reported
- 17 Apr 2019
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Blood Pressure Medication
Timeline
| 4 Mar 2019 | Recall initiated by company | |
| 7 Apr 2019 | Classified by FDA | +34 days |
| 17 Apr 2019 | Published in enforcement report | +10 days |
Companies usually start a recall weeks before the FDA classifies and publishes it; the gap above is that lag.
Reason for recall
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Nitrosamines are impurities that can form during drug manufacturing or storage. Above the FDA acceptable intake limit, long-term exposure may raise cancer risk. The FDA advises patients to keep taking the medicine until they have a replacement.
Product as listed by the FDA
Losartan Potassium 100 mg Tablets # 30 Losartan potassium tablets USP, 100 mg are white to off white, film coated, tear drop shaped tablets, debossed with "H" on one side and "145" on the other side.
Where it was distributed
Product was distributed to a physician's office in California.
Questions about this recall
Why was it recalled?
CGMP Deviations:Traces amounts of N-Nitroso N-Methyl 4- amino butyric acid (NMBA) impurity found in Active Pharmaceutical Ingredient (API).
Which lots are affected?
Pharma Pac NDC: 76519-1033-03, Pharma Pac Lot # LTO00EW, Exp. 11/19, MFG NDC 31722-0702-30, MFG Lot # LOP17087, Exp. 11/2019.
Where was it sold?
Product was distributed to a physician's office in California.
What should I do if I have it?
Check the lot number on your package against the affected lots. If it matches, contact the pharmacy that dispensed it or your prescriber before stopping any medication.
What does Class II mean?
Class II means the product may cause temporary or medically reversible health problems, or the probability of serious harm is remote.
Read the official FDA notice · Source record retrieved 26 Sep 2026. The FDA describes openFDA data as unvalidated; the official notice takes precedence. This page reports the record and gives no medical advice.
More recalls from H J Harkins
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Acetaminophen and Codeine Phosphate recalled by H J Harkins Company | H J Harkins | Manufacturing (CGMP) Deviations | AZ, CA |
| Drug | CLASS II | Acetaminophen 500 mg tablet packaged in a) 30-count bottles recalled | H J Harkins | Packaging Defects | Nationwide |
| Drug | CLASS II | Ranitidine, a), b), c), d), e) recalled by H J Harkins Company | H J Harkins | Nitrosamine Impurity | 4 states |
| Drug | CLASS II | Neomycin 3.5 mg/g / Polymyxin B10000 USP Units/g recalled | H J Harkins | Manufacturing (CGMP) Deviations | CA |
| Drug | CLASS II | Diphenhydramine HCL Liquid, 12.5 mg recalled by H J Harkins Company | H J Harkins | Sterility | Nationwide |
Other Losartan # recalls
All 98| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Losartan Potassium and Hydrochlorothiazide Tablets recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma USA | Foreign Material | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP, 25 mg recalled by Strides PharmaLosartan Potassium | Strides Pharma | Foreign Material | Nationwide |
| Drug | CLASS II | Losartan potassium & Hydrochlorothiazide Tablets 100 mg/25 recalledLosartan Potassium And Hydrochlorothiazide | Macleods Pharma Usa | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 25 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |
| Drug | CLASS II | Losartan Potassium Tablets, USP 100 mg recalled by PD-Rx PharmaceuticalsLosartan Potassium | PD-Rx Pharmaceuticals | Potency & Assay | Nationwide |