Reported Dec 18, 2019 · Ongoing

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10),…

Amneal Pharmaceuticals, Inc.

Moderate riskThis product could cause temporary or reversible health problems — stop using it.

What you should do

Stop using the affected lot and contact the recalling firm for the return or refund process. Check the FDA enforcement report for lot-level detail.

Firm contact: Amneal Pharmaceuticals, Inc. · 50 Horseblock Rd · Brookhaven, NY · 11719-9509

Ranitidine Tablets, USP 150 mg a).60-count bottles (NDC 65162-253-06) , b).100-count bottles (NDC 65162-253-10), c).180-count bottles (NDC 65162-253-18), d).500-count bottles (NDC 65162-253-50) and e)1000-count bottles (NDC 65162-253-11).

Lot codes and dates: 270 of 270 codes
AR171764A
11/2019
AR171875A
11/2019
AR171876A
11/2019
AR171981A
11/2019
AR180020C
1/2020
AR180206A
1/2020
AR180207A
1/2020
AR180208A
1/2020
AR180438A
2/2020
AR180439A
2/2020
AR180481A
3/2020
AR180482A
3/2020
AR180483A
3/2020
AR181690A
10/2020
AR181691A
10/2020
AR181806A
11/2020
AR190058A
12/2020
AR190059A
12/2020
AR190183A
1/2021
AR190184A
1/2021
AR171984A
12/2019
AR180020B
1/2020
AR180675A
4/2020
AR180868B
5/2020
AR181807A
11/2020
AR190366B
2/2021
AR171986A
12/2019
AR171987A
12/2019
AR180255A
1/2020
AR180441A
2/2020
Amount recalled: N/A

The agency filed one notice per product. You are reading one of them; the other 4 are below.

CGMP Deviations: Impurity N-nitrosodimethylamine (NDMA) found in API

This product could cause temporary or reversible health problems — stop using it.

The guide adds the identifying codes laid out for scanning, symptoms to watch for, a timeline, and news coverage of this recall.

Free recall alerts

One email when a matching recall is published. No account, no cost, unsubscribe in one click.

We email you about recalls and nothing else. Every send has a one-click unsubscribe, and you can change your preferences any time without an account.