CLASS II Drug recall · Reported 12 Feb 2020 · FDA Enforcement Report
Ranitidine Hydrochloride (powder) recalled
Spectrum Laboratory Products is recalling Ranitidine Hydrochloride (powder), USP, distributed in 11 states. The recall was initiated on 14 Jan 2020 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-0825-2020
- FDA event ID
- 84799
- Recalling firm
- Spectrum Laboratory Products, Gardena, CA
- Classification
- Class II
- Status
- Terminated
- Recall initiated
- 14 Jan 2020
- FDA classified
- 4 Feb 2020
- Reported
- 12 Feb 2020
- Type
- Voluntary: Firm initiated
- Customers notified by
- Letter
- Reason category
- Nitrosamine Impurity
- Drug class
- Stomach & Acid Reflux Medication
Timeline
| 14 Jan 2020 | Recall initiated by company | |
| 4 Feb 2020 | Classified by FDA | +21 days |
| 12 Feb 2020 | Published in enforcement report | +8 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: Presence of NDMA impurity detected in product.
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
Ranitidine Hydrochloride (powder), USP, Rx only, Spectrum Chemical Mfg Corp., a) 1 gram, b) 5 grams, c) 25 grams, d)100 grams, e) 500 grams, f) 1 Kilogram
Where it was distributed
The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
ArizonaCaliforniaFloridaGeorgiaNew JerseyPennsylvaniaRhode IslandSouth CarolinaTexasUtahWyoming
Questions about this recall
Why was it recalled?
CGMP Deviations: Presence of NDMA impurity detected in product.
Which lots are affected?
Lot #:11E0585, Exp. October 2023
Where was it sold?
The recalled API was distributed to pharmacies in the following states: AZ, CA, FL, GA, NJ, PA, RI, SC, TX, UT, WY. The API was also distributed internationally to Canada and UAE.
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 Spectrum Laboratory Products
All 9| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS I | Epinephrine (L-Adrenaline), USP, CAS 51-43-4 amber recalled | Spectrum Laboratory Products | Packaging Defects | Nationwide |
| Drug | CLASS II | Estriol [(16a, 17B)-Estra-1,3,5(10)-triene-3,16,17-triol recalled | Spectrum Laboratory Products | Potency & Assay | Nationwide |
| Drug | CLASS II | Fentanyl Citrate USP, Active Pharmaceutical Ingredient recalled | Spectrum Laboratory Products | Foreign Material | 4 states |
| Drug | CLASS II | Levonorgestrel, U.S.P. active pharmaceutical ingredient recalled | Spectrum Laboratory Products | Manufacturing (CGMP) Deviations | Nationwide |
Other Ranitidine recalls
All 55| Reported | Class | Recall | Company | Reason | Where |
|---|---|---|---|---|---|
| Drug | CLASS II | Ranitidine 150 mg, a) 60 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine 300 mg, 30 Tabs recalled by Direct Rx | Direct Rx | Nitrosamine Impurity | FL, GA |
| Drug | CLASS II | Ranitidine Tablets, USP, 150 mg x 10 blister card) recalled | American Health Packaging | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | Ranitidine Oral Solution, USP, 150 mg/, [ x Dose Cups recalled | Precision Dose | Nitrosamine Impurity | Nationwide |
| Drug | CLASS II | ranitidine hydrochloride, USP a) bottles recalled | PD-Rx Pharmaceuticals | Nitrosamine Impurity | 12 states |