American Health Packaging Recalls Ranitidine Tablets Due to NDMA Levels
American Health Packaging is recalling 53,619 cartons of Ranitidine Tablets, 150 mg, due to potential N-Nitrosodimethylamine (NDMA) amounts above FDA-established levels.
The agency’s classification
FDA (Drugs): Class II
Class II is a situation in which use of or exposure to a violative product may cause temporary or medically reversible adverse health consequences, or where the probability of serious adverse health consequences is remote.
This is the agency’s own classification, taken from its notice. The severity score below is our assessment, not the agency’s. How recall classes work
What this means for you
Our assessment, not the agency’s: severity 4/5 (Severe).
The hazard poses a serious risk of illness, injury, or structural failure. 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 for significant injury or health risk scenarios.
Plain-English summary
American Health Packaging is recalling 53,619 cartons of Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only. The product is packaged and distributed by American Health Packaging in Columbus, Ohio. The affected NDC carton number is 60687-322-01 and the NDC Unit Dose Card number is 60687-322-11.
The recall was initiated due to Current Good Manufacturing Practice (CGMP) deviations involving potential N-Nitrosodimethylamine (NDMA) amounts above levels established by the FDA. The affected lots include 179516, 179745, 180712, 180819, 181403, 182544, 183155, 183236, 185739, 186600, and 186702, with expiration dates ranging from 12/31/2019 to 12/31/2020.
The product was distributed nationwide in the USA. Consumers and healthcare providers should stop using the recalled product and contact their healthcare provider or pharmacist for guidance on alternative treatments or returns.
The recalled product
- Product
- Ranitidine Tablets, USP, 150 mg, 100 Tablets (10 tablets x 10 blister card), Rx Only, Packaged and Distributed by: American Health Packaging, Columbus, Ohio 43217. NDC carton: 60687-322-01; NDC Unit Dose Card: 60687-322-11
- Manufacturer
- American Health Packaging
- Category
- Drug — Prescription Medication
- Affected units
- 53,619
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 (17)
- Lot
- expiry: Lots 179516
- 179745
- exp 12/31/2019
- Lot 180712
- exp 02/29/2020
- Lot 180819
- exp 04/30/2020
- Lots 181403
- 182544
- 183155
- 183236
- exp 05/31/2020
- Lots 185739
- 186600
- 186702
- exp 12/31/2020
Distribution
Distributed nationwide across the United States.
Related recalls
Same manufacturer · American Health Packaging
See all →- LowBuprenorphine Sublingual Tablets Recalled for Labeling Mix-up
FDA (Drugs) · 2026-09-09
- ModerateNitrofurantoin Capsules 100 mg recalled for failed dissolution specifications
FDA (Drugs) · 2022-05-25
- ModerateCyanocobalamin Injection Recalled Due to Subpotency and Assay Non-Compliance
FDA (Drugs) · 2022-05-04
- SevereOxycodone Hydrochloride Oral Solution Recall Due to Impurity Failure
FDA (Drugs) · 2022-03-16
- ModerateMetoprolol Succinate ER Tablets Recall for Failed Dissolution
FDA (Drugs) · 2022-02-02
Same hazard · ndma contamination
See all →- SevereMetformin Hydrochloride Extended-Release Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2022-02-02
- ModerateMetformin 750 mg Extended Release Recalled for NDMA Contamination
FDA (Drugs) · 2022-01-19
- HighMetformin Hydrochloride Tablets Recalled for NDMA Contamination
FDA (Drugs) · 2021-06-30
- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA
FDA (Drugs) · 2020-11-25
- SeverePreferred Pharmaceuticals Recalls Metformin HCl Extended Release Tablets Due to NDMA
FDA (Drugs) · 2020-07-08
Similar recalls
- SevereRemedyRepack Recalls Ranitidine Tablets Due to Potential NDMA Contamination
FDA (Drugs) · 2020-01-29
- SevereAmerican Health Packaging Recalls Ranitidine Syrup Due to NDMA Impurity
FDA (Drugs) · 2020-01-08
- LowNabumetone Tablets Recalled for Missing Medication Guide Labeling
FDA (Drugs) · 2020-07-01
- SevereRite Aid Ranitidine Tablets Recalled for Potential NDMA Contamination
FDA (Drugs) · 2019-11-20
- SevereAAA Pharmaceutical Recalls Ranitidine Tablets Due to NDMA Impurity
FDA (Drugs) · 2020-01-15
- SeverePD-Rx Recalls Ranitidine Hydrochloride Tablets Due to NDMA Contamination
FDA (Drugs) · 2020-02-12