Sandoz Recalls Ranitidine Capsules Due to NDMA Impurity
Sandoz is recalling specific lots of Ranitidine Hydrochloride Capsules 150mg because a trace amount of the impurity NDMA was detected.
What this means for you
Illness, injury, or structural failure has been reported. Stop using the product immediately and contact the manufacturer for a refund or repair.
Our severity reasoning: The recall is classified as FDA Class II, which corresponds to a Severe rating under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA).
Plain-English summary
Sandoz, Inc. is recalling 100,314 bottles of Sandoz Ranitidine Hydrochloride Capsules 150mg (NDC 0781-2855-60). The affected product was distributed nationwide in the United States. The recall is due to the detection of a trace amount of an unexpected impurity, N-nitrosodimethylamine (NDMA), which is a CGMP deviation.
The affected lots include HC9266, HD1865, HP9441, JK7994, and JK8659. The source text does not specify the exact distribution dates or the specific states where the product was sold, only that the distribution was U.S. Nationwide.
Consumers should check their medication for the NDC number 0781-2855-60 and the lot numbers listed above. If the product matches these details, it should be returned to the pharmacy or point of purchase for a refund or replacement. Patients should consult their healthcare provider for alternative treatment options if necessary.
The recalled product
- Product
- Sandoz Ranitidine Hydrochloride Capsules 150mg 60 Capsules Rx Only Manufactured by Sandoz Inc. Princeton, NJ Product of India NDC 0781-2855-60
- Manufacturer
- Sandoz, Inc
- Category
- Drug — Prescription Medication
- Affected units
- 100,314
Distribution
Distributed nationwide across the United States.
Part of a larger recall action
This product is one of 3 recalled by Sandoz, Inc under a single FDA (Drugs) recall action. The agency files each product separately, so the size of the action is not visible from this page alone.
See all 3 products in this recall →Related recalls
Same manufacturer · Sandoz, Inc
See all →- LowFocalin XR 5mg capsules carry incorrect or missing lot and expiry
FDA (Drugs) · 2026-06-24
- ModerateCyclophosphamide injection vials recalled after a transportation temperature excursion
FDA (Drugs) · 2025-09-24
- ModerateCiprofloxacin and dexamethasone otic suspension recalled following temperature abuse
FDA (Drugs) · 2025-09-17
- SevereBuffered penicillin G potassium vials may actually contain cefazolin for injection
FDA (Drugs) · 2025-07-09
- SevereSandoz cefazolin cartons contained vials labeled as penicillin G potassium
FDA (Drugs) · 2025-07-09
Same hazard · ndma impurity
See all →- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets
FDA (Drugs) · 2021-05-26
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-02-10
- SevereNostrum Recalls Metformin Hydrochloride Extended-Release Tablets Due to NDMA Impurity
FDA (Drugs) · 2021-01-20
- SevereDenton Pharma Recalls Metformin Hydrochloride Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-11-11
- SevereDirect Rx Recalls Metformin Hydrochloride Extended Release Due to NDMA Impurity
FDA (Drugs) · 2020-11-11