Appco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
Appco Pharma LLC is recalling Ranitidine Capsules 300 mg because the active ingredient contained the impurity N-nitrosodimethylamine (NDMA).
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' severity score under the rubric, particularly given the presence of a known carcinogenic impurity (NDMA) in a pharmaceutical product.
Plain-English summary
Appco Pharma LLC is recalling Ranitidine Capsules 300 mg, 30 count bottles (NDC 62559-691-30). The recall involves 1,632 bottles of the prescription medication. The product was manufactured by Appco Pharma LLC in Piscataway, NJ, and distributed by ANI Pharmaceuticals, Inc. in Baudette, MN.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations, specifically the discovery of the impurity N-nitrosodimethylamine (NDMA) in the active pharmaceutical ingredient (API). The affected batches are #1905227UE and #1905228UE, both with an expiration date of April 2021.
The product was distributed to six major distributors and wholesalers, some with multiple locations, who may have further distributed the product. Consumers and healthcare providers should check their inventory for these specific batch numbers and expiration dates. If found, the product should be returned to the distributor or disposed of according to local regulations.
The recalled product
- Product
- Ranitidine Capsules 300 mg, 30 count bottles. Rx only, Manufactured by: Appco Pharma LLC, Piscataway, NJ 08854, Distributed by: ANI Pharmaceuticals, Inc., Baudette, MN 56623, NDC 62559-691-30.
- Manufacturer
- Appco Pharma LLC
- Category
- Drug — Prescription Medication
- Affected units
- 1,632
Is your product affected?
Check your packaging against the codes below. If any of them match, the product is part of this recall.
Lot numbers (3)
- Batch # 1905227UE
- exp. date Apr-2021 1905228UE
- exp. date Apr-2021
Distribution
Distribution scope not specified by the agency.
Part of a larger recall action
This product is one of 2 recalled by Appco Pharma LLC 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 2 products in this recall →Related recalls
Same manufacturer · Appco Pharma LLC
See all →- HighPrazosin hydrochloride 100-count bottles recalled over nitrosamine impurity
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride further lots recalled over nitrosamine impurity levels
FDA (Drugs) · 2026-04-08
- HighPrazosin hydrochloride tablets recalled over nitrosamine impurity above limits
FDA (Drugs) · 2026-04-08
- ModerateVenlafaxine Extended-Release Tablets Recalled for Missing Tablet Identification
FDA (Drugs) · 2025-01-29
- SevereAppco Pharma Recalls Ranitidine Capsules Due to NDMA Impurity
FDA (Drugs) · 2020-01-15
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